Cell Therapy QC Analytical Specialist (4/10 Shift)

Regulatory Jobs; Rockville (MD); Vor Ort; USD 81.000 - 121.000; Vollzeit

Zusammenfassung

Regulatory Jobs in Rockville, Maryland seeks a QC Analytical Specialist to perform routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods (flow cytometry, ELISA, PCR, automated cell counting) with high quality and data integrity.

The position is on-site, four days per week, ten hours per day (Sunday through Wednesday).

Qualifikationen

• 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-based assays, 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 maintain a positive, solutions‑oriented attitude to drive outcomes.
• Ability to work on-site in a lab-based role for the assigned shift.

Aufgaben

• Analytical testing: 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.
• Instrument operation and maintenance: Operate, calibrate, and perform routine maintenance and troubleshooting on relevant instruments; document activities and escalate issues promptly.
• Documentation and compliance: 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.
• Quality systems: 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.
• Training and knowledge sharing: Complete method qualifications and maintain analyst proficiency; provide peer training on established procedures as qualified.
• Planning and teamwork: Coordinate daily testing priorities, sample receipt, and material control with the team; communicate testing status and risks to ensure on-time lot release.

Kenntnisse

Flow cytometry

ELISA

PCR

Cell culture

Cell counting / viability

Instrument software

Ausbildung

Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline

Tools

LIMS

SOP/documentation software

Jobbeschreibung

Regulatory Jobs in Rockville, Maryland seeks a QC Analytical Specialist to perform routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods (flow cytometry, ELISA, PCR, automated cell counting) with high quality and data integrity.

The position is on-site, four days per week, ten hours per day (Sunday through Wednesday).