Associate, Quality Control Analytical

AstraZeneca•Los Angeles, CA

22h

About The Position

AstraZeneca is seeking an energetic and experienced individual with a cell therapy quality control background to join its Quality Control (QC) team. The Associate will contribute to the product pipeline by performing QC analytical method qualification, lot release testing, sample management, and other assigned tasks. The position helps ensure the laboratory meets CGMP Quality Control standards. The role 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.

Requirements

Bachelor's degree, preferably in Biology or equivalent, and 1–2 years of relevant CGMP laboratory experience; or an Associate's degree, preferably in Biology or equivalent, and 2–3 years of relevant CGMP laboratory experience.
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 cell culture, flow cytometry and 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.
Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced, dynamic team setting.
Excellent attention to detail, strong communication skills, and the ability to analyze raw data effectively.

Nice To Haves

Experience in Cell or Gene Therapy.
Well versed 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.