Associate, Quality Control Analytical

AstraZeneca•Los Angeles, CA

2d•$55,921 - $83,881

About The Position

AstraZeneca is seeking an energetic and experienced individual with a cell therapy quality control background to join its Quality Control team. The Associate will contribute to the product pipeline by performing QC analytical method qualification, executing lot release testing, managing samples, and completing other assigned tasks. The role helps ensure that the laboratory meets CGMP Quality Control standards. It includes weekend technical support and may require non-traditional schedules to support operational and business needs. Scheduled work hours and shift assignments are subject to change.

Requirements

Bachelor's degree, preferably in Biology or equivalent, with 1–2 years of relevant CGMP laboratory experience; or an 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 analyses for CGMP lot release and stability testing, using techniques including cell culture, flow cytometry, cell-based methods, PCR (dPCR, qPCR), and immunoassays (ELISA).
Familiarity with basic computer applications such as Microsoft Outlook, Word, and Excel.
Experience operating and maintaining temperature-controlled storage units.
Ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced, dynamic team setting.
Ability to provide weekend technical support and work non-traditional schedules as needed.

Nice To Haves

Experience in cell or gene therapy.
Proficiency in analytical techniques such as flow cytometry, qPCR, dPCR, cell-based potency, and/or ELISA.

Responsibilities

Perform CGMP release and stability testing for cell therapy products and in-process samples, including techniques such as flow cytometry, ELISA, cell-based cytotoxicity, and qPCR/dPCR.
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 and observations and complete 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.