QC Analytical Specialist — Cell Therapy (4x10h)

AstraZeneca; Rockville (MD); Vor Ort; USD 81.000 - 121.000; Teilzeit

Benefits dieser Stelle

Health, dental and vision coverage

Retirement programs

Paid time off

Zusammenfassung

AstraZeneca in Rockville, MD is seeking a Specialist, QC Analytical to perform routine and non-routine analytical testing in support of cGMP lot release and stability for cell therapy products.

You will execute approved methods (flow cytometry, ELISA, PCR) with strong data integrity, maintain documentation, and collaborate with cross-functional teams to meet timelines. On-site lab role with a 4-day, 10-hour shift (Sun–Wed).

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 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.

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 escalator 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

Data integrity

Ausbildung

Bachelor’s degree in Biological Sciences or related discipline

Tools

Cytometry software

LIMS

Jobbeschreibung

AstraZeneca in Rockville, MD is seeking a Specialist, QC Analytical to perform routine and non-routine analytical testing in support of cGMP lot release and stability for cell therapy products.

You will execute approved methods (flow cytometry, ELISA, PCR) with strong data integrity, maintain documentation, and collaborate with cross-functional teams to meet timelines. On-site lab role with a 4-day, 10-hour shift (Sun–Wed).