Specialist, Quality Control Analytical, Cell Therapy (Wed - Saturday)
AstraZeneca
Summary
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.
Job description
Role Overview
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, Wednesday - Saturday.
Role Responsibilities
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.
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
- Maintain a positive, solutions-oriented attitude
- Ability to work on-site in a lab-based role for the assigned shift
Benefits
- 401(k) Retirement Programs
- Paid Time Off
- Vacation
- Holiday Pay
- Leaves
- Health Insurance
- Dental Coverage
- Vision Coverage
- Short-Term Incentive Bonuses
- Equity-Based Awards
Company overview
AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.