Associate Quality Control Analytical

AstraZeneca•Rockville, MD

2d•Onsite

About The Position

The Associate, QC Analytical, supports cGMP lot release and stability testing for cell therapy products by preparing samples and reagents, accomplishing test methods, operating instruments per SOPs, and maintaining accurate documentation. The role focuses on learning and performing routine activities with high quality and data integrity, assisting with lab maintenance and inventory, and supporting QC operations to meet timelines.

Requirements

Associate’s degree with three (3) years of relevant lab experience.
Laboratory experience in a pharmaceutical/biotech or related academic setting.
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 escalation of discrepancies.
Demonstrates effective cross-functional collaboration, embraces 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.

Nice To Haves

Exposure to QC, cGMP environments, or regulated documentation is a plus.
Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline with at least three (3) months of industry internship experience.

Responsibilities

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.
Prepare reagents, controls, and standards; perform sample receipt, labeling, and chain-of-custody according to SOPs.
Operate assigned instruments per SOPs including daily checks, calibrations, and routine maintenance.
Record data contemporaneously in relevant electronic systems; ensure completeness, accuracy, and compliance with ALCOA+ principles.
Maintain inventory of consumables and reagents; perform lab housekeeping, 5S, and equipment cleaning; support sample logistics and courier/chain-of-custody processes.
Assist in documenting deviations and events; provide data and observations for investigations (e.g., OOS/OOT); follow implemented CAPAs and change controls.
Complete method training and analyst qualifications; maintain proficiency through periodic reassessments; seek feedback and demonstrate continuous learning.
Communicate testing status, material needs, and issues to the team; support scheduling and sample coordination to meet lot release timelines.