Senior Specialist Quality Control Analytical

AstraZeneca • Gaithersburg, MD

2d • Onsite

About The Position

The Senior Specialist, QC Analytical, provides operational and technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stability. The role focuses on right‑first‑time analytical assay execution (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell‑based assays) and end‑to‑end laboratory readiness, including people and equipment oversight. Responsibilities span routine testing execution, laboratory operations management, quality record management, and audit/inspection readiness. The Senior Specialist partners closely with other QC teams, MSAT/Analytical Development, Manufacturing, QA, and Supply Chain to ensure the lab operates safely, compliantly, and efficiently to meet patient supply timelines.

Requirements

• Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline
• Minimum of 5 years' experience in pharmaceutical/biotech QC with emphasis on laboratory operations/management in a cGMP setting.
• Demonstrated experience operating a QC laboratory in a regulated environment with knowledge of cell therapy specific considerations (e.g., chain of identity/chain of custody, rapid turnaround for patient supply, phase‑appropriate controls).
• Proven ability to plan and coordinate laboratory operations, manage competing priorities, and communicate status, risks, and mitigations to cross‑functional stakeholders; experience presenting in audits/inspections.
• Hands‑on experience with qualification and maintenance of key QC instruments and with lab informatics (LIMS/ELN/LES, instrument data systems); strong command of data integrity controls and computerized systems compliance.
• Competence in leading investigations and implementing CAPAs; working knowledge of change control, risk management, and documentation practices aligned to cGMP and GDP.
• Ability to design and deliver effective training; mentor analysts on safe, compliant, and efficient lab practices; cultivate a culture of quality and continuous improvement.
• Effective cross‑functional partner with Manufacturing, MSAT/AD, QA, Supply Chain, Facilities, and EHS; comfortable operating in a fast‑changing environment and adjusting plans to meet patient‑critical timelines.
• Ability to work on-site in a lab-based role; willingness to support off-hours/weekend testing as needed to meet patient supply timelines.
• This role will require occasional weekend support.

Nice To Haves

• Experience in cell therapy lot release and stability preferred.

Responsibilities

• Perform and oversee QC testing for cell therapy products (flow cytometry, ELISA, PCR, cell based assays, cell count/viability) per approved methods, ensuring adherence to cGMP, GDP, and data integrity expectations (ALCOA+).
• Coordinate day‑to‑day QC lab activities including sample intake, scheduling, and testing flow.
• Build testing schedules; balance priorities to meet lot release and stability timelines.
• Maintain accurate, contemporaneous records in relevant electronic systems and forms; author/review SOPs, test methods, and certificates of analysis; ensure readiness for internal/external audits and regulatory inspections.
• Train and coach junior team members on methods, cGMP/GDP, safety, and data integrity; support qualification of analysts and ongoing proficiency assessments.
• Coordinate testing schedules, sample logistics, and material controls; communicate status and risks; escalate issues proactively to meet lot release timelines.
• Drive 5S, visual management, standard work, and deviation trend reviews; improve flow and increase right‑first‑time performance.

Benefits

• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health coverage
• Dental coverage
• Vision coverage
• Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles

What This Job Offers

• Job Type: Full-time
• Career Level: Senior