Associate, Quality Control Analytical

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. 

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. 

The annual base pay (or hourly rate of compensation) for this position ranges from $55, 920.80 to $83,881.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.