Specialist, Quality Control Analytical, Cell Therapy (Sun - Wed)

AstraZeneca • Rockville, MD

5d • Onsite

About The Position

The Specialist, QC Analytical, performs routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods—including flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays—with high quality and data integrity, maintains accurate documentation, and participates in laboratory investigations. The QC Specialist collaborates within the QC team and with cross-functional partners to meet testing timelines and ensure compliant operations.

This is an on-site laboratory position in Rockville, Maryland, working four days per week for 10 hours per day, Sunday through Wednesday.

Requirements

• Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or a related discipline.
• At least 3 years of experience with laboratory techniques relevant to cell therapy or biologics.
• Hands-on experience with analytical methods for cell therapy or biologics, including flow cytometry, ELISA, PCR, cell culture, cell count/viability, and functional cell-based assays.
• Familiarity with associated instrumentation and software.
• Effective cross-functional collaboration skills.
• Flexibility in a constantly evolving environment and a positive, solutions-oriented attitude.
• Ability to work on-site in a laboratory-based role for the assigned shift.

Responsibilities

• Execute QC testing for cell therapy products using flow cytometry, ELISA, PCR, cell-based assays, and cell count/viability methods in accordance with approved methods and SOPs, cGMP, GDP, and ALCOA+ expectations.
• Operate, calibrate, maintain, and troubleshoot relevant instruments; document activities and promptly escalate issues.
• Maintain accurate, contemporaneous records in applicable electronic systems and forms; author or review SOPs and test methods; support readiness for audits and regulatory inspections.
• Participate in laboratory investigations, including OOS/OOT results and deviations, by gathering data, performing preliminary assessments, and documenting findings.
• Support implementation of CAPAs and change controls.
• Complete method qualifications and maintain analyst proficiency; provide peer training on established procedures when qualified.
• Coordinate daily testing priorities, sample receipt, and material control with the team.
• Communicate testing status and risks to support on-time lot release.

Benefits

• Eligibility for short-term incentive bonuses.
• Equity-based awards for salaried roles.
• Qualified retirement programs.
• Paid time off, including vacation, holidays, and leaves.
• Health coverage.
• Dental coverage.
• Vision coverage.

What This Job Offers

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