Specialist, Quality Control Analytical, Cell Therapy; Sunday - Wednesday (4x 10 hour day shift)
About The Position
The Specialist, QC Analytical, performs routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays) with high quality and data integrity, maintains accurate documentation, and participates in laboratory investigations. The QC Specialist collaborates within the QC team and with cross-functional partners to meet testing timelines and ensure compliant operations. This position is for a 4 days per week, 10 hours per day shift, Sunday through Wednesday.
Requirements
- Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline.
- Minimum of 3 years’ experience with laboratory techniques relevant to cell therapy or biologics
- Hands-on experience with analytical methods for cell therapy or biologics, including flow cytometry, ELISA, PCR, cell culture, cell count/viability, and functional cell-based assays; familiarity with associated instrumentation and software.
- Demonstrate effective cross-functional collaboration, embrace flexibility in a constantly evolving environment, and maintains a positive, solutions‑oriented attitude to drive outcomes.
- Ability to work on-site in a lab-based role for the assigned shift.
Responsibilities
- Execute QC testing for cell therapy products (flow cytometry, ELISA, PCR, cell based assays, cell count/viability) per approved methods and SOPs, meeting cGMP, GDP, and ALCOA+ expectations.
- Operate, calibrate, and perform routine maintenance and troubleshooting on relevant instruments; document activities and escalate issues promptly.
- Maintain accurate, contemporaneous records in relevant electronic systems and forms; author/review SOPs and test methods, ensure readiness for internal/external audits and regulatory inspections.
- Participate in laboratory investigations (e.g., OOS/OOT, deviations) by gathering data, performing preliminary assessments, and documenting findings; support implementation of CAPAs and change controls.
- Complete method qualifications and maintain analyst proficiency; provide peer training on established procedures as qualified.
- Coordinate daily testing priorities, sample receipt, and material control with the team; communicate testing status and risks to ensure on-time lot release.
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
