AstraZeneca · 2 hours ago
Associate, Quality Control Analytical, Cell Therapy
AstraZeneca is a global biopharmaceutical company, and they are seeking an Associate for their Quality Control Analytical team. The role involves supporting cGMP lot release and stability testing for cell therapy products, focusing on routine analytical testing, sample preparation, and maintaining documentation with high data integrity.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Routine analytical testing: Complete assays under supervision (e.g., automated cell counting, viability, ELISA, PCR, flow cytometry, basic cell culture handling) following approved methods and cGMP/GDP expectations
Sample and reagent preparation: Prepare reagents, controls, and standards; perform sample receipt, labeling, and chain-of-custody according to SOPs
Instrument operation: Operate assigned instruments per SOPs including daily checks, calibrations, and routine maintenance
Documentation and data integrity: Record data contemporaneously in relevant electronic systems; ensure completeness, accuracy, and compliance with ALCOA+ principles
Lab support and readiness: Maintain inventory of consumables and reagents; perform lab housekeeping, 5S, and equipment cleaning; support sample logistics and courier/chain-of-custody processes
Quality systems participation: Assist in documenting deviations and events; provide data and observations for investigations (e.g., OOS/OOT); follow implemented CAPAs and change controls
Training and qualification: Complete method training and analyst qualifications; maintain proficiency through periodic reassessments; seek feedback and demonstrate continuous learning
Collaboration and communication: Communicate testing status, material needs, and issues to the team; support scheduling and sample coordination to meet lot release timelines
Qualification
Required
Basic hands-on experience with laboratory techniques relevant to cell therapy or biologics (e.g., pipetting, aseptic technique, ELISA basics, PCR setup, cell counting/viability)
Understanding of core cGMP concepts, Good Documentation Practices, and laboratory compliance; ability to follow SOPs precisely and ask clarifying questions
Strong focus on right-first-time execution, accurate record-keeping, and timely response to escalation of discrepancies
Demonstrates effective cross-functional collaboration, accepts flexibility in a constantly evolving environment, and maintains a positive, solutions oriented attitude to drive outcomes
Enthusiasm to develop new technical skills and expand responsibilities with experience
Ability to work on-site in a lab-based role; willingness to support off-hours/weekend testing as needed to meet patient supply timelines
Associate's degree with relevant lab experience may be considered
At least one year of laboratory experience in a pharmaceutical/biotech or related academic setting. Exposure to QC, cGMP environments, or regulated documentation is a plus
Preferred
Bachelor's degree in Biological Sciences, Chemistry, Biochemistry, or related discipline
Benefits
Qualified retirement programs
Paid time off (i.e., vacation, holiday, and leaves)
Health, dental, and vision coverage in accordance with the terms of the applicable plans
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
H1B Sponsorship
AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Recent News
Essential Business
2026-01-24
2026-01-23
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