Associate, Quality Control Analytical
AstraZeneca
Summary
AstraZeneca is seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by performing QC analytical method qualification, execute lot release testing, sample management and other assigned tasks. This position is essential for ensuring that the laboratory meets the high standards required for CGMP Quality Control.
Job description
This position includes weekend technical support and may require non-traditional work schedules to support operational and business requirements. Scheduled work hours and shift assignments are subject to change.
Essential Responsibilities
- Perform CGMP release and stability testing (e.g., flow cytometry, ELISA, cell-based cytotoxicity, qPCR/dPCR) for cell therapy products and in-process samples.
- Receive, verify, label, store, and track samples, controls, and reagents to ensure traceability and timely transfer to testing laboratories, using paper and electronic systems and operating temperature-controlled units.
- Author and/or review analytical test results and technical documents, including analytical method qualification protocols and reports, and standard operating procedures (SOPs).
- Document activities, record observations, and complete all paperwork in accordance with CGMPs, SOPs, and protocols.
- Execute protocol-driven method qualification, verification, and validation, and support analytical technology transfer and method lifecycle management activities.
- Escalate and document invalid, OOS/OOT results; support deviations, CAPAs, and change controls; and contribute to investigations as needed.
- Follow Safety, Health, and Environmental procedures, maintain a safe and organized laboratory environment, and use appropriate PPE and aseptic/biocontainment practices.
- Perform other duties as assigned.
Qualifications
- Bachelor's degree preferably in Biology or equivalent with 1-2 years of relevant CGMP laboratory experience; OR Associate's degree preferably in Biology or equivalent with 2-3 years of relevant CGMP laboratory experience
- The ideal candidate will possess excellent attention to detail, strong communication skills, and the ability to analyze raw data effectively.
- Experience with sample receipt, storage and transfer.
- 1-2 years executing routine and non-routine analysis for CGMP lot release and stability testing using techniques including but not limited to cell culture, flow cytometry and cell-based methods, PCR (dPCR, qPCR), Immunoassays (ELISA), etc.
- Familiar with basic computer applications such as Microsoft Outlook, Word and Excel
- Experience operating and maintaining Temperature-Controlled Storage Units.
- Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting.
Preferred Qualifications
- Experience in Cell or Gene Therapy.
- Well versed in various analytical techniques Flow cytometry, qPCR, dPCR, cell-based potency and/or ELISA experience.
Requirements
- Bachelor's degree preferably in Biology or equivalent with 1-2 years of relevant CGMP laboratory experience; OR Associate's degree preferably in Biology or equivalent with 2-3 years of relevant CGMP laboratory experience
- Excellent attention to detail, strong communication skills, and ability to analyze raw data effectively
- Experience with sample receipt, storage and transfer
- 1-2 years executing routine and non-routine analysis for CGMP lot release and stability testing using techniques including but not limited to cell culture, flow cytometry and cell-based methods, PCR (dPCR, qPCR), Immunoassays (ELISA), etc.
- Familiar with basic computer applications such as Microsoft Outlook, Word and Excel
- Experience operating and maintaining Temperature-Controlled Storage Units
- Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting
Benefits
- Short-Term Incentive Bonuses
- Equity-Based Awards
- Retirement Programs
- Paid Time Off
- Health Insurance
- Dental Insurance
- Vision Insurance
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.