Quality Assurance Specialist

About the Role:
Location: Tarzana, CA (100% onsite, possible travel to Santa Monica)
Duration: 12 months w/possibility of extension
Working Hours: 4x10s (8am-530pm) starting either Sunday or Wednesday (TBD)
Pay: $31.92 per hour
Position 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 Operations.
This position includes weekend technical support and operates on one of the following shifts, which 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 2-3 years of relevant CGMP laboratory experience; OR Associate's degree preferably in Biology or equivalent with 5 years of relevant CGMP laboratory experience. PHD overqualified
-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), 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.
Top 3 Skills to Have:
Batch disposition
Ability to handle deviations and Capas
Cell therapy experience (nice to have)
Preferred Qualifications:
-Experience in Cell or Gene Therapy.
-Well versed in various analytical techniques Flow cytometry, dPCR, cell-based potency and/or ELISA experience.