Specialist, Quality Control Analytical, Cell Therapy (Sunday - Wednesday)

AstraZeneca•Rockville, MD

1d•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, while maintaining high quality, data integrity, and accurate documentation. The Specialist participates in laboratory investigations and collaborates with the QC team and cross-functional partners to meet testing timelines and ensure compliant operations. This is an on-site, lab-based 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.
Ability to collaborate effectively cross-functionally, adapt in an evolving environment, and maintain a positive, solutions-oriented attitude.
Ability to work on-site in a lab-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 and cGMP, GDP, and ALCOA+ expectations.
Operate, calibrate, maintain, and troubleshoot relevant instruments; document activities and promptly escalate issues.
Maintain accurate, contemporaneous records in relevant electronic systems and forms.
Author and review SOPs and test methods, and support readiness for internal and external audits and regulatory inspections.
Participate in laboratory investigations, including OOS/OOT events 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 help ensure on-time lot release.