Senior Specialist, QC Microbiology, Cell Therapy
Listed on 2026-07-13
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Quality Assurance - QA/QC
Production QC/QA, Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Senior Specialist, QC Microbiology, Cell Therapy
Position Summary:
Responsible for supporting QC testing for in-process, final product, stability samples and for supporting environmental and facility monitoring, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts.
- Perform method transfer/verification/validation, routine testing of in-process, final product, and stability samples.
- Perform environmental/facilities monitoring and microbiological testing.
- Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
- Perform data verification, data review and review of GMP documentation for general and complex methods.
- Perform document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
- Train and mentor others on QC test methods, processes, and procedures.
- Perform other tasks as assigned.
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
- High problem‑solving ability/mentality, technically adept and logical.
- Ability to communicate effectively with peers, department management and cross‑functional peers about task status, roadblocks and needs.
- Ability to work in a fast‑paced team environment, meet deadlines, and prioritize work.
- Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.
- Bachelor's degree or equivalent in science; advanced degree preferred;
Netherlands MLO level 4 required. - 4+ years of relevant microbiological testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
- Demonstrated experience with microbiological techniques.
Summit West - NJ - US $40.97 - $49.64 per hour. The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.
Benefits- Health Coverage:
Medical, pharmacy, dental, and vision care. - Wellbeing Support Programs: BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Paid Time Off:
Exempt Employees flexible time off (unlimited, with manager approval), 11 paid national holidays (variant by location). Non‑exempt hourly employees 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays. - Additional time off: unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown.
BMS is committed to equal opportunity. We will consider qualified applicants with arrest and conviction records pursuant to applicable laws. We support reasonable accommodations for people with disabilities. For more information, see our comprehensive Equal Employment Opportunity statement.
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