• Fill, cap, and label chemical products accurately
• Weigh materials using electronic balances
• Manually fill liquid and powdered substances
• Operate semi-automated equipment for filling tasks
• Clean semi-automated equipment routinely
• Conduct fills in controlled environments
• Handle hazardous product fills following protocols
• Transfer bulk solutions using pumps
• Filter bulk materials with in-line or vacuum filters
• Torque caps manually using wrenches
• Set up and operate semi-automated capping systems
• Hand-label products as needed
• Operate automated labeling machinery
• Assist with filling line operations including loading and pack-off
• Assemble and pack product kits according to procedure
• Safely operate material handling equipment
• Clean laboratory glassware and batch tanks

• Follow all safety procedures and wear appropriate PPE
• Comply with Good Documentation Practices (GDP)
• Record equipment usage and verify calibration status
• Identify and correct unsafe conditions
• Attend required safety training, meetings, and activities
• Support quality systems and maintain ISO 13485 and ISO 9001 compliance
• Participate in 6S and continuous improvement initiatives
• Maintain clean work areas and audit readiness

• High school diploma or GED equivalent required

• Minimum 3 months of experience in chemical weighing, laboratory work, or product packaging
• Experience in ISO/GMP regulated environments preferred

• Basic math skills, including metric conversions
• Basic computer literacy
• Familiarity with safety procedures, GMP, SOPs, and UOPs
• Strong hand-eye coordination and mechanical aptitude
• Effective verbal and written communication
• Legible handwriting
• Ability to problem solve and use hand tools
• Strong interpersonal skills
• Must be able to occasionally lift 50 lbs

• Must be able to stand for extended periods and perform repetitive motions
• Work may involve hazardous chemicals and biological materials
• Exposure to fumes, airborne particles, and reactive or toxic substances
• Occasional exposure to extreme temperatures, humidity, and vibration
• Proximity to moving mechanical parts
• Loud noise levels may occur in the work environment
• Physical actions include walking, reaching overhead, stooping, kneeling, twisting, crouching, crawling, and frequent hand use
• May be required to wear safety equipment including air helmet, masks, steel-toe shoes, gloves, aprons, Tyvek suits, goggles, and safety glasses
• Must be able to occasionally lift/move up to 70 lbs
• Visual requirements include close, distance, color, peripheral, and depth vision, along with the ability to adjust focus

• High School Diploma or equivalent
• Ability to read, comprehend, and follow written procedures; understand and follow verbal instructions
• Ability to handle and maneuver small components and parts under microscope
• Ability to seat and stand for long periods of time
• Able to perform repeated tasks such as grab, pinch, pull, twist 

• Manual Assembling of medical devices
• Assemble and use tools under the microscope for long periods of time
• Hand soldering
• Cleanroom environment
• Maintain written and electronic documentation 

• This position is responsible for the production of high-quality medical devices within a cleanroom environment
• Working under close supervision, may perform a combination of assembly, repair, and test operations on medical catheters
• Maintain Compliance and Quality while performing routine assignments according to standardized procedures
• Ensure that relevant job documentation for cell operations and functions is accurate and up to date
• Be able to clearly communicate ideas, problems and solutions
• Maintain a positive attitude when interacting with internal customers and external customers
• Follow safety guidelines while onsite
• As an FDA regulated company, maintaining accurate documentation ensures all parts are traceable and quality issues can be addressed 

Job Title: MES Engineer (Entry-Level)

• Design, develop, test, and implement MES solutions with a focus on continuous improvement.
• Create and execute detailed project plans using MES tools such as Siemens, Camstar, and other software platforms.
• Provide administrative support and configuration for MES applications.
• Analyze and understand standard manufacturing processes to inform MES design.
• Collaborate with engineering and quality assurance teams to ensure compliance with industry standards and regulations.
• Train and guide associates on MES systems, functionality, and best practices.
• Monitor and track product flow and process data within the MES system.
• Manage user access within MES software, including adding and deleting users.
• Troubleshoot and resolve plant floor execution issues and business system integration problems.
• Develop and execute qualification test plans to validate MES configurations and ensure system readiness.
• Implement production technology transfer requirements into IT and automation systems.
• Collaborate with cross-functional teams to optimize MES workflows during system implementation and upgrades.
• Contribute to the development of MES best practices, documentation, and reporting tools for operational performance tracking.
• Provide ongoing field support for MES issues to maintain system reliability and efficiency.

• Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field (preferred)
• Internship or coursework in manufacturing systems, automation, or MES (a plus)
• Strong problem-solving skills and attention to detail
• Excellent communication and interpersonal skills
• Ability to work both independently and in a team environment
• Familiarity with MES platforms such as Siemens, Camstar, or equivalent is a plus

• Opportunity to work with cutting-edge manufacturing technologies
• Hands-on training and mentoring from experienced professionals
• Cross-functional team collaboration and exposure to real-world applications
• Career growth in a fast-paced, innovative environment

• Performs routine assignments according to specified and/or standardized procedures. Work is closely and continually reviewed.
• Ensure that relevant job documentation for cell operations and functions is accurate and up to date.
• Be able to clearly communicate ideas, problems and solutions to all levels of manufacturing management in both written and oral form.
• Maintain a positive attitude when interacting with internal customers and external customers such as tours.
• Follow safety guidelines and utilize appropriate safety devices when performing all operations. Participate in continuous improvement/quality initiatives in order to enhance production processes to achieve quality and profitability metrics.
• Maintain accurate records to ensure traveler and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products.
• Demonstrates a basis understanding of Lean Manufacturing.
• Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics that continuously seek to improve the quality of operations.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements 

• Ability to read, comprehend, and follow written procedures
• Understand and follow verbal instructions
• Understanding of and ability to utilize electronic data collection systems and computer software packages.
• Ability to prioritize work by determining the sequencing and timing of different jobs based on precedence and importance.
• Ability to handle and maneuver small components and parts.
• Ability to make critical decisions and judgments with minimal supervision.

• High School degree or equivalent

• Ability to operate powered industrial equipment and perform hand weighing operations. Also able to setup and run drum massager, delumper, filling machine, capper, automated labeler, and other ergonomic equipment.
• Knowledge of product flow throughout the packaging process.
• Ability to effectively communicate in a professional manner with all levels of staff both orally and written.
• Ability to work in a group setting.
• Ability to demonstrate attention to detail.
• Ability to work quickly and adjust to changing priorities in a fast-pace environment.
• Demonstrated problem-solving and team building skills with the ability to work with a diverse group of people.

• Provides training and operational support to the department
• Maintains high-quality work environment by sharing knowledge and experiences so team members are motivated to perform at their highest level
• Keeps supervisor informed of potential and/or existing concerns
• Leads by example in performing core packaging job elements by meeting or exceeding performance expectations, following health and safety guidelines, job accuracy, and following company and regulatory requirements.
• Participates in and supports the development and implementation of process improvement projects and leads test cycles to challenge current practices, improve system efficiency, enhance customer service, and maintain compliance
• Troubleshoot problems within the department
• Demonstrates working knowledge of department operating systems.
• Maintains orders, work areas and stock locations in a safe, clean, and organized manner.
• Reports unsafe or potentially unsafe hazards to any member of management
• Miscellaneous duties and tasks as assigned
• Exemplary attendance and adherence to schedule

• Operate processing equipment:

• Fill, cap, and label chemical products accurately.
• Use electronic balances to weigh materials properly.
• Operate semi-automated equipment for liquid and powder fills.
• Perform manual fills as needed.
• Conduct routine cleaning of semi-automated equipment.
• Operate within environmentally controlled areas.
• Perform fills for hazardous materials.
• Transfer bulk solutions with pumps.
• Filter bulk materials using pumps, in-line filters, or vacuum filters.
• Manually torque caps using wrenches.
• Operate semi-automated cappers and automated labelers.
• Hand-label products as needed.
• Assist with loading bottles and packing operations on the fill line.
• Pack kits according to standard procedures.
• Safely operate material handling equipment to transport materials.
• Clean laboratory glassware and batch tanks.

• Follow all safety procedures consistently.
• Wear and maintain Personal Protective Equipment (PPE).
• Comply with Good Documentation Practices (GDP).
• Document equipment use and verify calibration status.
• Stay familiar with common hazards and take corrective actions as needed.
• Participate in safety trainings, meetings, and documentation activities.
• Support continuous improvement and process enhancements.
• Maintain ISO 13485 & ISO 9001 compliance.
• Engage in 6S activities and maintain audit readiness.

• Follow Merck’s Code of Conduct.
• Work cooperatively with team members to achieve departmental goals.
• Maintain good housekeeping practices and teamwork on the production floor.

• High School diploma or GED required.

• Preferred: At least 3 months of chemical weighing, laboratory, filling, or packaging experience.
• Preferred: At least 3 months working in an ISO/GMP regulated environment.

• Basic math skills (metrics & conversions).
• Basic computer literacy.
• Knowledge of safety rules, GMP, SOPs, and UOPs.
• Strong mechanical aptitude.
• Good hand-eye coordination.
• Ability to use hand tools and perform repetitive tasks.
• Effective communication (written and oral).
• Legible handwriting.
• Problem-solving skills.
• Strong interpersonal and teamwork skills.
• Able to occasionally lift up to 50 lbs.

• Extended periods of standing and repetitive movements.
• Working with or near hazardous chemicals and human source materials.
• Exposure to fumes, airborne particles, toxic, caustic substances, and vibrations.
• Occasional work in extreme cold, heat, or humid conditions.
• Work around moving mechanical parts in potentially loud environments.
• Frequent physical activities: walking, reaching, stooping, kneeling, twisting, crouching, crawling, handling materials, operating tools.
• PPE use required: air helmet, mask, safety shoes, apron, rubber/Tyvek suits, protective gloves, safety glasses/goggles.
• Must occasionally lift/move up to 70 lbs.
• Specific vision requirements: close, distance, color, peripheral vision, depth perception, and focus adjustment.

• Temp-to-perm career opportunity in a regulated manufacturing environment.
• 4-day workweek for better work-life balance.
• Comprehensive safety and compliance training.
• Opportunity to gain experience in FDA, ISO, and GMP-regulated production processes.
• Grow your career with an industry-leading life sciences and pharmaceutical company.

• High School Diploma or equivalent
• 1-3 year previous experience
• Ability to operate forklift 

• Will operate a forklift, but this is a warehouse housekeeping position
• Sweep Floors - Pick up Plastic/Cardboard/Trash (As Needed per Management)
• Trash (Take bins back and replace with new)
• Reject Bins (Take bins back and replace with new)
• Recycling Plastic and Cardboard (Take bins back, bail, and replace with new)
• Shop Vac the dock plates
• Lowbay tunnels & Cold Storage Sweep (As Needed per Management)
• Floor Scrubber Lowbay tunnels & Cold Storage
• Stacker Inputs and Outputs
• Floor Scrubber in HiBay (During Stacker Cleaning)
• Sweep Floors - Pick up Plastic/Cardboard/Trash (As Needed per Management)
• Recycling Plastic and Cardboard (Take bins back, bail, and replace with
• Clean Lowbay Dock Area (Loading Trash Truck, Dunnage and recycling
• Floor Scrubber in case pick tunnel (Includes E & F Tunnel)
• Floors - Sweep to remove all debris. Run floor scrubber in all aisle ways. Mop as needed.
• Drains - Clean to remove all debris. Mop as needed.
• Clean Layer Picker (Confirm available with Dan Colson)
• Cobweb Removal of interior perimeter walls of the entire building
• Bullpen cleaning (Sweeping & Vacuum Carpets, Moping, Dusting, shining Stainless steal, Door Windows)

• Performs daily assigned standard work according to the department’s governing processes (i.e., GSP’s, OPs, QPs, or SOPs).
• Ensures materials are distributed on time and accurately per the production schedule.
• Inventory counting and adherence to inventory control processes.
• Provides support to non-operations stakeholders with their good receipts, allocation, movements, and shipments.
• Learns and operates automated systems/equipment, and sequences of operation, including Equipment setup, operation, and cleaning; Monitoring, maintaining, and troubleshooting of equipment.
• Responsible for daily attendance in Tier meetings.
• Responsible for the operation of powered industrial vehicles in a safe and compliant manner.
• Required to handle or manage hazardous materials.

• Proactively collaborate with peers in other shifts/functions to achieve daily targets.
• Support the leaders to maintain and cultivate the organization's culture. Collaborate with the team and leaders to achieve departmental goals.
• Communicates outside the department with manufacturing and associated organizations.

• Maintain the Right to Operate and ensure that all processes are performed safely and healthily; Address and escalate any potentially unsafe hazards.
• Ensure accuracy and completeness of all procedures and instructions related to the proper receipt, quarantine, storage, and disbursement of materials as it relates to FDA, OSHA, FAA, QSR, ISO, Good Manufacturing Practices, manufacturing exception events (MEEs), and other company policies and procedures.
• Audit readiness (OSHA, FAA, FDA, etc.); Performs department initiatives to prepare for internal/external audits and inspections.
• Timely reporting of safety hazards, incidents, and near misses.
• Completes all assigned training. Responsible for maintaining 95% or above training compliance.

• Organize and maintain logistics areas according to 6S principles.
• Identifies gaps and may participate in process improvements and continuous improvement initiatives utilizing Lean principles and tools.
• Performs other duties as assigned.

• High School Diploma/GED required.
• 1 year of relevant work experience, preferably in a GMP environment.
• 1 year of experience operating power industrial vehicles.

• Demonstrated experience with Lean/Continuous Improvement.
• Ability to read, write and comprehend English.
• Strong communication skills - written and verbal.
• Ability to be flexible and agile in a fast-paced, constantly changing, and high-volume environment.
• Strong organizational skills and attention to detail.
• Ability to use PC-based applications and general data entry skills.
• Previous experience with ERP systems; SAP preferred.
• Ability to work with cross-functional teams.
• Self-motivated.
• Ability to have prompt, regular and reliable worksite attendance.

• May stand, walk, sit, kneel, bend, and crouch for a combined 4 or more hours per day.
• May push, pull, and lift a minimum of 50 pounds. Repetitive, consistent movements of the wrists, hands, and fingers.
• Required to have good near visual acuity to perform activities throughout the processes in the assigned area.
• Must be able to work in, on, around, over, and under fixed equipment and machinery; to work from lifts and ladders; to manipulate heavy equipment, tools, and supplies; to concurrently manipulate multiple controls and machinery; and to wear and work in personnel protective equipment.
• This is an essential position supporting the organizational goals requiring attendance on weekends, holidays, and during an emergency or exceptional conditions.

• Quality and Safety 10% - Safety review and complete training.
• Production 65%
• CI 10% - 6S, CI actions and Hype initiatives.
• Teamwork and Collaboration 15% - Pass Down and Tier meetings.

• Data Analytics & Reporting:
  • Generate monthly performance reports on savings, compliance, and KPIs.
  • Analyze freight and shipping compliance including use of accounts, service levels, and routing guides.
  • Perform cost modeling and data-driven analyses to identify efficiency gains.
• Strategic Sourcing:
  • Develop and manage RFI/RFP processes; analyze results to inform sourcing strategies.
  • Track and report monthly savings from sourcing activities.
• Supplier & Contract Management:
  • Prepare quarterly and annual supplier performance reviews.
  • Maintain carrier contracts and update rate cards quarterly.
• Procurement Operations:
  • Oversee invoice auditing and payment workflows.
  • Handle new carrier setups, purchase orders, and resolve discrepancies.

• Bachelor’s degree in Supply Chain, Finance, Economics, or Business Administration.
• Minimum of 3 years’ experience in procurement, supply chain, or financial planning.
• Expertise in Microsoft Excel and Power BI (or similar analytics tools) is required.
• Strong communication, problem-solving, and self-management skills.
• Ability to comprehend and interpret complex financial statements (P&L, Income Statement, Cash Flow).
• Familiarity with international freight logistics (parcel, air, FTL, LTL) is a plus.

• Start Date: 30 days.
• Duration: Temp-to-hire. Candidate will be onboarded as a direct employee with our client pending performance reviews. 
• Location: Remote within the continental U.S.
• Hours: May include non-traditional hours to support international operations.

• High School Diploma or equivalent
• Energetic, quick learner, excellent attention to detail
• At least 1 year of experience

• Ideal candidate has reviewed docs in a GMP setting or worked in a quality role in a GMP setting
• Bachelors degree in any life science, GMP, Pharma industry experience
• Technical documentation for product design a plus

• Directly responsible for ensuring documents submitted to Quality are compliant to company procedures, regulatory requirements, and the quality manual
• Performs project review and audit of Device History Files (DHF’s) and technical files including:
  • Stability protocols and reports
  • Summary of Safety and Performance reports
  • Risk Management plans, reports, FMEAs
  • Post-Market Surveillance plans and reports
  • Performance evaluation plans and reports including scientific, clinical, and analytical documents.
  • Product composition reports
  • Sensitivity and specificity/Repeatability and reproducibility reports
  • Specification reports
  • General Safety and Performance Requirement reports
• Performs review of data and records supporting the DHF while assessing for good documentation and record keeping practices ensuring appropriate requirements are met
• Obtains information for clarification from process owners while providing appropriate and relevant feedback
• Coordinates files upon completion of review for upload into EDMS as necessary
• Electronically signs as technical approver for quality on applicable documents and within the validated electronic databases
• Write, revise and/or review Standard Operating Procedures
• Maintain extensive knowledge of Standard Operating Procedures and policies
• Supports internal and external audits as required
• Understands, supports, and communicates Company mission, vision, and values
• Understands and follows the requirements of the quality system
• Maintains current training requirements
• Trains other staff members as requested
• Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies
• Recommends, provides, or initiates solutions by actively providing suggestions for improvement
• Must be willing and able to work on weekends or extended hours as needed
• Follows regulatory and standard requirements as applicable to the site, i.e. MDSAP, ISO 13485, IVDD/IVDR, and compliance to the site Quality Manual
• Review and approve quality documentation and records
• Collaborates and coordinates with internal stakeholders to identify, escalate, and resolve quality issues
• Other duties as assigned or required

Remote Supplier Quality Auditor – Europe

• Coordinate with suppliers to schedule audits and manage pre-audit logistics, including travel arrangements when necessary.
• Conduct supplier audits (onsite or remote) according to applicable Quality Management System (QMS) standards and regulations.
• Prepare clear and detailed supplier audit reports meeting customer-specific requirements.
• Maintain updates in audit tracking systems (e.g., EtQ).
• Review supplier corrective actions and evaluate objective evidence for acceptance.
• Participate in audit-related meetings with clients and internal teams.
• Perform other duties as required by BEPC management.

• Languages: Must be fluent in English and German (written and verbal).
• Thorough knowledge of QMS auditing principles and techniques.
• Experience auditing to standards and regulations including:
  • ISO 9001
  • ISO 13485
  • MDSAP
  • ISO 17025
  • 21 CFR Parts 820 and 11
• Preferred: Additional European language proficiency.
• Strong leadership and collaborative skills to engage with all levels of management.
• Self-directed with the ability to work independently and manage priorities.
• Strong relationship-building and professional communication abilities.
• Positive, proactive “Can-do” attitude and commitment to meeting deadlines.
• Proficient in Microsoft Office tools (Word, Excel).
• Strong multitasking and problem-solving skills.
• Excellent written and verbal communication abilities.

• Required:
  • Bachelor’s degree in a technical or engineering field.
  • 3–5 years of auditing experience within the medical device industry or with associated suppliers.
• Preferred Certifications:
  • Certified Quality Auditor (CQA) or Certified Medical Device Auditor (CMDA).
  • ISO 9001/13485 certified lead auditor.

• This is a remote position requiring reliable home office setup.
• Standard work hours: Monday – Friday, 8:00 AM – 5:00 PM (flexibility needed to accommodate customer needs, including evenings or weekends).
• Flexible engagement as a part-time freelancer or full-time contractor depending on availability.

• Travel as needed:
  • Freelance/Part-time: As required by assignments.
  • Full-time: Approximately 60% travel for audits and client needs.

• ✅ Fluent English & German language skills
• ✅ Certified Quality Auditor (CQA) / Lead Auditor preferred
• ✅ Supplier auditing experience
• ✅ Proficiency in Microsoft Office
• ✅ Expertise in QMS standards and regulatory compliance

• Deliver prompt, professional service via calls and emails in a fast-paced environment.
• Address customer inquiries about product availability, order status, pricing, billing, and delivery.
• Accurately process orders and returns; resolve issues following company policies.
• Collaborate with internal departments to resolve customer concerns and ensure SLA compliance.
• Stay current on product information, systems, and reference tools to provide accurate assistance.
• Escalate complex issues to specialized teams as needed.

• Education: High school diploma required; associate’s or bachelor’s degree preferred.
• Experience:
  • Minimum of 2 years in a high-volume call center.
  • Background in order processing and customer service.
  • Proficient in CRM tools, ERP systems, and Microsoft Office.
  • Experience in medical device support or healthcare is a plus.
• Language: English required; Spanish proficiency is a strong plus.

• Start Date: ASAP
• Location: Remote (U.S.-based)
• Duration: Long-term contract
• Pay Rate: $20/hr
• 
  

• Subject matter expert in formulating stocks and bulk solutions.
• Improves cycle time, quality, safety, and delivery.
• Conducts in-process testing, troubleshooting, and SOP development.
• Supports verifications and material reservations.
• Plans and executes validations, leads process improvements.
• Supports 3+ reagent product lines.
• Manages documentation and inventory in validated systems.
• Collaborates with planning, QC, and production teams.
• Ensures end-of-shift communication.
• Assists with batch record reviews.

• Ensures safe practices and reports hazards.
• Leads safety improvements and quality audits readiness.
• Documents production processes in compliance with regulatory standards.
• Manages non-conformances and corrective actions.
• Oversees document changes and maintains training compliance.
• Maintains and certifies equipment.

• Works with peers and functions to exceed targets.
• Onboards and trains new employees.
• Maintains trainer certification.
• Supports organizational culture and goals.
• Communicates with internal and external teams.

• Expert in 6S and lean improvements.
• Tracks and analyzes operational metrics.
• Collaborates on maintenance and engineering improvements.
• Engages in and may lead tier meetings.

• Associate's Degree (required).
• Bachelor's Degree (preferred).

• 3 years with Associate’s Degree or 2 years with Bachelor’s Degree (required)
• Experience in a regulated industry and with GDP/GMP (required)

• Lab techniques, pipetting, handling hazardous materials
• Lean/Continuous Improvement
• Google Suite, ERP systems
• Critical thinking, problem-solving, organizational skills
• Strong verbal and written communication
• Time management in high-volume environments
• Ability to use industry technology and tools
• Able to work cross-functionally and independently
• Fluent in English
• Adheres to PPE and respirator use
• Physically able to stand, walk, lift 50 lbs, and perform repetitive tasks
• Work in varied physical conditions with equipment
• Travel Requirements: As needed, based on business needs

• Consistently uses company concepts, policies and procedures, familiar with and follows standard practices.
• Projects are assigned with defined scope and goals.
• Direction is provided by more senior engineering staff, management or project leader. - Participates in efforts to define new components, products or processes and identify technical challenges.
• Makes suggestions to improve work processes.
• Creates potentially patentable components for systems, or processes.
• Plans and executes assigned projects; utilizes thorough technical and theoretical understanding of numerous techniques.
• Analyzes data, evaluates results, forms conclusions and provides/implements process or document improvements.
• Applies advanced engineering knowledge to projects. - Executes experiments; participates in experimental design.
• Utilizes DOE where appropriate.
• Participates in technical team activities.
• Shares knowledge and expertise with others.
• Participates in project planning, process updates and contributes to experimental design. - Prepares and delivers presentations of project results to own or other groups.
• Monitors work to ensure quality, and continuously promote Quality First Time.

• Demonstrates potential for technical proficiency, engineering creativity, collaboration with others and independent thought.
• Strong understanding of engineering principles and concepts.
• Strong mechanical problem-solving skills.
• Hands-on ability/experience with electro-mechanical and small-scale fluidic/pneumatic systems.
• Root-Cause Analysis and troubleshooting skills and experience.
• Good written and verbal communication skills.
• Self-direction, ability to own tasks and work autonomously to complete assigned investigative tasks.
• Cross-functional team experience, experience solving technical problems of a multi-disciplinary nature.
• Excellent design skills, ability to develop simple solutions with minimum impact to existing design.

• BS degree in a directly related discipline.
• Experience: Requires a minimum of 4 years of related experience.

1. Initial phone screen
2. Onsite panel interview

• Must have medical device industry experience
• Experience as a Project Analyst or Project Coordinator supporting program managers
• Excellent communication skills, capable of interacting with upper leadership
• Proven ability to work independently and proactively
• Preferred: Scientific or engineering background

• Support senior project managers on complex, cross-functional programs
• Assist with maintaining master schedules, resource allocation, and budgets
• Track, manage, and facilitate the resolution of project risks and issues
• Process and maintain design control documentation and Design History Files (DHF)
• Maintain documentation supporting design inputs, risks, and trace matrix data
• Draft design control documents (e.g., project plans, trace matrices) for review
• Coordinate design reviews and ensure action items are tracked and resolved
• Engage with team members, including senior leadership, to complete deliverables
• Communicate project status updates to core team leaders and stakeholders
• Serve as liaison with QA Auditors for DHF audits, as needed
• Perform additional function-related activities as required by business needs

• Required: Bachelor’s Degree in Science or Engineering
• Preferred: Project management coursework or certification (e.g., CAPM, PMP)

• 2–5 years of experience in a regulated industry, ideally supporting project teams
• Familiarity with design controls and regulatory requirements

• Solid understanding of project management fundamentals (timelines, budgets, financials)
• Proficient in project management tools, including:
• Microsoft Project
• Smartsheet
• JIRA
• Asana
• Planview
• Excellent organizational skills and high attention to detail
• Ability to interact effectively with diverse teams, from leadership to technical staff
• Strong problem-solving and communication abilities

• Works closely with key personnel and participates in technical training to develop expert level understanding of assays, instrumentation, and software as it applies to documentation.
• Manages multiple user documentation projects at a time.
• Designs and implements work instructions, area guidelines, knowledge base topics, style guides/templates and departmental SOPS. Analyze current processes, identifying and evaluating options and suggesting changes with the intent of improving efficiency, or quality.
• Guides or performs the creation of new documentation and the review, revision and enhancement and approval of existing documentation. Identify and implement document changes to maintain consistency across product lines/processes.
• Performs and troubleshoots instrumentation, assays, software applications, etc. to develop and improve content.
• For INVs/CAPAs, conduct investigations using analytical skills and judgement, conferring with other writers and SMEs when appropriate, to determine root cause, and to recommend and implement changes.
• Supports core team members and project team leads in developing documentation timelines and deliverables.
• Attends project/core team meetings as required as extended core team representative and make recommendations regarding the IFU project schedule and deliverables required considering information learned at these meetings.
• When needed coordinates and manages translation projects. Work with translation vendors in managing translation development and procurement process. Responds to questions from the vendor with minimal help from management.
• Coordinates the collaborative review process and leads collaborative review sessions. Establish review and edit cycles based on the project timeline and availability of resources. Train cross-functional team on review process as needed.
• Coordinates the transition of documentation through preproduction, regulatory submission, and production phases as appropriate. Act as approver as needed.
• Uses discretion and judgement, including consideration of business priorities, to prioritize deliverables and manage “expedites.”
• Independently integrate SDS information into package inserts to comply with GHS standards.
• For inventoried items, prepare specs and work with procurement to ensure accuracy.
• Coordinates final production of documents w/ print vendors as required.
• As required, assign document change responsibilities, and provide training and assistance to EDMS users.
• Processes labeling project change orders in EDMS/Agile system.
• Initiates and drives departmental continuous improvement and implementation of best practices.
• Participates in professional development and works towards obtaining/maintain certification relevant to job functions.
• Works in conjunction with other departments where appropriate.
• Must follow all applicable FDA regulations and ISO requirements.

• Preferred Minimum Non-Technical Degree: College Degree
• Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree

• Preferred Minimum Non-Technical Degree: 5-8 Years
• Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelor’s Degree, 1-3 Years with Master’s Degree, 0-1 Years with PhD
• Experience with PLM systems
• Experience with source controls such as Team Foundation Server and GitHub is beneficial.

• In depth knowledge of Technical Writing Theory and Practices, Design Theory
• Proficiency in Adobe FrameMaker, MadCap Flare, InDesign, Author-IT and MS Office applications
• Project and time management skills
• Analytical, problem-solving, and troubleshooting skills
• Interpersonal skills
• Exceptional written and verbal communication skills. Adapts communication style to different audiences. Creates precise, accurate technical documentation. Able to facilitate group discussions.
• Knowledge of Agile, HTML or CSS is beneficial.

• High School Diploma or equivalent
• Flexibility with shift
• Time management, communication, adaptability and problem solving
• Exposure to Salesforce, Microsoft, and scanning preferred but not required
• Medical background preferred but not required

• Assisting the dept with outgoing and incoming mail, scanning, uploading documents to patient accounts
• Processing of financial assistance applications
• Case creation along with insurance verifications
• Assist with handling inbound and outbound phone calls to address patient inquiries and provide information about services
• Task Completion: Complete assigned tasks efficiently and accurately, ensuring all duties are performed to high standards
• Case Load Creation: Assist in creating and managing caseloads, ensuring accurate and timely processing of patient cases
• Documentation: Ensure patient documentation is correct, complete, and up to date, maintaining high standards of accuracy
• Insurance Verification: Verify and interpret insurance benefits and upload correct patient estimates to ensure accurate billing
• Financial Assistance Processing: Obtain all required documents for processing applications and is familiar with associated policies
• Administrative Support: Perform basic administrative tasks such as data entry, filing, and maintaining patient records
• Cross-Functional Collaboration: Ensures effective communication and teamwork across different teams to achieve common goals and drive organizational success 
• Emotional Intelligence: Act in a professional manner and be self-aware of their tone and energy, ensuring interactions are respectful, empathetic, and conducive to a positive work environment

• High School Diploma or equivalent
• Must be able to work alone or in a team and can follow procedures exactly

• Responsible for proper maintenance and operation of drug manufacturing equipment
• Accurately weighing raw materials and active ingredients and combining them into a blend
• Keeps the equipment and facility clean and in a state of good repair
• Participates in the completion of work orders, including batch record documentation per cGMP (current good manufacturing process)
• Accurately follows and completes documentation with minimal errors or corrections
• Completes training, including cGMP and safety training in a timely manner

• High School Diploma or equivalent
• 2+ years of previous experience 
• Must be able to read, comprehend and follow English written procedures at a 6th grade level
• Must have good basic math skills at a 6th grade level
• Must be able to speak, follow verbal instructions and communicate effectively in English
• Possesses understanding of and ability to utilize electronic data collection systems and computer software packages
• Must have good dexterity to handle and maneuver small components and parts
• Ability to prioritize work by determining the sequencing and timing of different jobs based on precedence and importance
• Ability to make critical decisions and judgments with minimal supervision

• Responsible for the production of high quality cardiovascular medical devices on a team within a manufacturing cell
• This position includes detailed assembly and operation of various equipment and machinery per documented procedures 
• This may include electronic assembly, casting/coating functions, mechanical assembly and packaging
• Cleans tools and equipment per documented procedures
• Disposes hazardous waste material on corresponding hazardous waste areas
• Assembles medical devices and related components
• Depending on work area, it may be a controlled cleanroom environment
• May include use of microscopes, use of hand tools, razor blades, syringes, soldering, adhesive bonding, and operating various equipment
• Performs routine assignments according to specified and/or standardized procedures
• Work is closely and continually reviewed
• Performs visual inspection and precision measurements on components and assemblies
• Performs tests on units using computerized test equipment
• Repairs and corrects devices/components using microscopes and applicable tools
• Packages devices ensuring all parts are accurate and documentation is complete
• Maintains accurate records to ensure travelers, shop floor paperwork and quality documents are accurate, all parts are traceable, and quality issues can be addressed to assure the quality of all products
• Follows safety guidelines and utilize appropriate safety devices and equipment when performing all operations
• Participates in continuous improvement/quality initiatives to enhance production processes to achieve quality and profitability metrics
• Notifies supervisor or lead of the need to replenish supplies/materials and of any production difficulties that cannot be readily corrected
• Participates with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics that continuously seek to improve the quality of operations. Cooperates in keeping a clean, sanitary work environment throughout the building
• Performs other related duties as directed or assigned

• Collaborate with scientists in Human Genetics department to analyze large datasets of genetic, genomic, and clinical data from internal studies (including our clinical trials and high throughput screens), collaborations with academic and industry partners, and public external data sets 
• Develop analytical approaches to integrate and interpret these data, delivering insights into disease biology to propel our translational goals 
• Coordinate the intake and preparation of new datasets as they become available for analysis 
• Document process, findings, and code 
• Present findings to the department and cross-functional collaborators and contribute to publications 

• Extensive experience in large-scale genetic/genomic data analysis including one or more of the following areas of expertise:
•  Understanding of principles of genetic epidemiology ○ Association analysis with array- and sequence-based genetic data 
• Analysis of sequence-based molecular assay data (e.g. RNA-Seq) including differential expression methods, single-cell sequencing data (eg scRNA-Seq, scATAC-Seq) and/or proteomic data 
• Integration of genetic and molecular data for multimodal analyses 
• PhD (or Masters with significant experience) in Statistical Genetics, Computational Biology, Bioinformatics, Genetic Epidemiology, or a related field 
• Fluent in R, python, and shell scripting. Some familiarity with C++ will be a plus 
• Experience working with git and high-performance computing (e.g. the slurm scheduling manager)
• Curiosity and desire to learn more about human genetics, bioinformatics, and biology 
• Ability to produce high-quality analysis results with minimal supervision. This includes meeting key deadlines and making sensible independent decisions 
• Good communication skills and experience working as part of a team

• Plan, schedule, and execute supplier quality audits, both remotely and onsite
• Assess conformance to applicable QMS standards including:
  • ISO 9001, ISO 13485, ISO 17025, MDSAP, 21 CFR Part 820 & Part 11
• Review documentation and conduct interviews to evaluate quality system compliance
• Document audit findings, nonconformances, and opportunities for improvement
• Generate clear, accurate, and professional audit reports and follow-up communications
• Maintain impartiality and confidentiality throughout all audit engagements
• Collaborate with client teams and suppliers to resolve audit-related queries
• Perform audits across a range of industries in line with client needs
• Submit invoices and required documentation in a timely and professional manner

• Fluency in spoken and written English; additional regional language skills a plus
• Strong understanding of quality management system auditing principles and techniques
• Demonstrated ability to self-manage, stay organized, and maintain documentation
• Effective communication skills to engage with stakeholders at all organizational levels
• Experience collaborating with suppliers and internal quality teams
• Proficiency in Microsoft Office tools (Word, Excel, Outlook)
• Ability to build and maintain positive professional relationships
• High degree of integrity, impartiality, and attention to detail

• Bachelor’s degree (or regional equivalent) in a technical field or engineering (required)
• 3–5 years of experience conducting QMS audits in the medical device industry or related supplier roles
• Experience auditing to ISO 9001, ISO 13485, MDSAP, 21 CFR 820/11, and ISO 17025
• Experience auditing laboratory activities preferred
• Lead Auditor Certification highly preferred:
  • ASQ CQA or CBA
  • ISO 9001 / ISO 13485 Lead Auditor

• Must operate as an independent contractor or self-registered business with a valid EIN (if applicable)
• Must provide proof of business liability insurance
• Compensation will be rendered via invoice submission for services performed

• Must be able and willing to travel throughout North America as needed to meet client and audit requirements
• Travel arrangements and reimbursement terms to be agreed upon per engagement

• Work with top-tier global clients in regulated, high-impact industries
• Flexible project-based assignments tailored to your expertise
• Independence and autonomy as part of a professional freelance network
• Opportunity to broaden your exposure across various regulated suppliers

• Review and approve all validation documentation for biopharmaceutical manufacturing processes, ensuring compliance with FDA, EMA, and other global regulatory requirements.
• Oversee and approve Facility and Equipment (FE) Validation documentation.
• Installation Qualification (IQ) – Verification that equipment is installed per design specifications. 
• Operational Qualification (OQ) – Testing of equipment functionality within specified operational limits. 
• Performance Qualification (PQ) – Ensuring systems operate consistently under real-world conditions 
• Protocols, discrepancies, summary reports, and periodic reviews to maintain validation status.
• Evaluate and approve vendor qualification documentation, ensuring that equipment and raw materials from suppliers meet biotech industry standards.
• Calibration, Maintenance, and Alarm Reviews
• Review and approve calibration records, preventive maintenance logs, and daily alarm reports to ensure the proper functioning of bioprocessing equipment.
• Environmental monitoring systems for temperature, humidity, and pressure differentials in cleanrooms.
• Ensure adherence to USP, ISO, and ICH guidelines for biotech manufacturing processes.

• Develop, implement, and maintain the Data Integrity Program to ensure compliance with: 
• FDA 21 CFR Part 11 (Electronic Records & Electronic Signatures). 
• EU Annex 11 (Computerized Systems in GMP). 
• ICH Q9 & Q10 (Quality Risk Management & Pharmaceutical Quality Systems).
• Assess change control proposals, deviations, and Corrective and Preventive Actions (CAPAs) to maintain compliance and mitigate risks.
• Implement audit trails, user access controls, and electronic documentation systems to protect data integrity in biotech operations.

• Act as a Subject Matter Expert (SME) for validation, engineering records, and data integrity, providing guidance to manufacturing, quality, and regulatory teams.
• Support regulatory inspections and client audits as the primary representative for validation records, engineering controls, and data integrity compliance.
• Mentor and lead a team of validation engineers and quality specialists, providing technical guidance on biotech validation challenges.
• Identify, implement, and standardize best practices in validation, engineering, and data integrity within the biotech industry.

• Partner with Process Development, Manufacturing, and Quality Assurance teams to optimize validation processes for biologics production.
• Develop and present reports on validation performance metrics, data integrity trends, and compliance status to senior leadership.
• Contribute to continuous improvement initiatives, leveraging new technologies and regulatory trends to enhance biotech manufacturing operations.

• Education: Bachelor’s or Master’s degree in Biotechnology, Engineering, Life Sciences, or a related field.
• Experience: Minimum 5+ years of validation and compliance experience in a biopharmaceutical or biotechnology manufacturing facility.

• Bioprocessing equipment validation (single-use systems, chromatography, sterile filtration, lyophilization) 
• Automation & computerized systems validation (CSV) for biotech production 
• Risk-based validation approaches (ASTM E2500, ISPE GAMP 5).

• Excellent analytical, problem-solving, and leadership abilities. 
• Strong understanding of regulatory expectations (FDA, EMA, ICH, ISO 13485 for medical biotech). 
• Effective communicator with experience managing cross-functional teams and external vendors. 

• Identify and implement process performance improvements related to Quality, Delivery, and Cost
• Design and execute change management plans to optimize product, people, and information flow
• Lead cross-functional teams to drive business improvement through Lean and Six Sigma tools
• Coach and mentor team members to develop continuous improvement capabilities
• Analyze data and manufacturing flows to reduce constraints and increase throughput
• Ensure compliance with quality and safety standards (ISO 13485, ISO 14001, OSHA 18001)
• Prepare and present business cases and project outcomes

• Education: Bachelor’s degree in Engineering or a related Science discipline (required)
• Experience: 1–3 years of experience in a business or manufacturing environment
• Strong understanding of Six Sigma, Lean methodologies, and Project Management
• Experience with continuous improvement tools like SPC, OEE, TQM, and CFM
• Green Belt or Black Belt certification (preferred)
• Knowledge of FDA regulations, GMP, and ISO standards
• Excellent communication and problem-solving skills

• Must be able to work onsite full-time
• Occasional travel (up to 10%) and flexibility for overtime or off-shift work if needed
• Ability to lead change and collaborate across teams
• Knowledge of cost control (COGS, Design to Value, standard cost development) is a plus

• Act in accordance with company policy
• Provide full time phone coverage (shift to be determined by management)
• Suggest new programs and or projects to promote customer service
• Determine appropriate action to take to resolve customer issues
• Determine when it is appropriate to escalate customer issues to management
• Work with Finance, Product Distribution and Customers to resolve disputes
• Act as customer advocate in investigating and responding to complaints while suggesting necessary process improvements to avoid recurrence
• Stay informed of current industry practices / trends
• Participate in the development and maintenance of department defined quality standards and measures
• Maintain effective and timely communication with team members as well as the supervisor regarding departmental issues
• Support corporate values
• Remain flexible to ever changing customer needs and requirements

• Process customer orders accurately
• Review inventory to determine appropriate customer order commitment.
• Maintain follow up on customer order issues.
• Interact with key customer purchasing personnel to advise of order status
• Ensure adherence to appropriate laws, regulations and programs

• Act as a liaison between customer, third party provider and GNE to facilitate customer returns.
• Ensure accurate posting of credits and debits in accordance to policy
• Ensure timely turnaround of customer authorizations

• Participating in the product launch process to ensure a positive outcome
• Administer special programs
• Support team decisions
• Respect diversity
• Being flexible with assigned schedule
• Have the ability to adapt to a constant changing environment
• Ability to work through conflicting, delayed or ambiguous information
• Actively Participate in various team initiatives; Lean Daily Management, etc.

• Decision Making – Thinks through problems clearly and logically; is decisive
• Technical and Business Expertise – Applies emerging knowledge and trend; builds strong relationships; contributes expertise within and beyond assigned area
• Communication - Listens well, expresses ideas fluently and logically, is open to input and feedback
• Teamwork and Collaboration – Creates an atmosphere of openness and trust; collaborates, offers support and encouragement
• Achieving Results – Is goal-directed and persistent; is accountable for meeting commitments, recognizes the contributions of peers

• Develop and optimize production processes for efficiency and quality.
• Oversee daily manufacturing operations, including scheduling and work orders.
• Lead plant maintenance and equipment calibration in collaboration with the Production Line and Mechanical Engineer Managers.
• Manage shipping, receiving, and inventory control processes.
• Maintain accurate digital records and inventory documentation.
• Hire, train, and motivate a team of manufacturing professionals.
• Implement strategies to enhance workplace productivity and employee engagement.

• Proven experience in plant or production management within a manufacturing setting.
• Strong leadership and team management skills, particularly in motivating and developing teams.
• Expertise in process improvement, inventory management, and workplace optimization.
• Familiarity with equipment calibration, plant maintenance, and repair.
• Excellent organizational and communication skills.
• Ability to pass a background check and drug screening.

• Salary Range: $65,000–$75,000/year, plus performance bonuses.
• Benefits: Comprehensive health insurance, 401(k) matching, and relocation assistance (negotiable).