Specialist, Quality Control Analytical, Cell Therapy

AstraZeneca; Rockville (MD); On-site; USD 81,000 - 121,000; Full time

Benefits offered by this job

Incentives program

Retirement plan

Paid time off

Health, dental, and vision coverage

Job summary

Regulatory Jobs is seeking a QC Analytical Specialist in Rockville, MD to perform routine and non-routine analytical testing supporting cGMP lot release and stability of cell therapy products. You will execute approved methods (flow cytometry, ELISA, PCR, cell-based assays) with data integrity and documentation, collaborating with cross-functional teams to meet testing timelines.

This role requires a Bachelor’s degree and at least 3 years of hands-on lab experience, with the ability to work

Qualifications

• Bachelor's degree required in Biological Sciences, Chemistry, Biochemistry, or related field.
• Minimum of 3 years’ experience with laboratory techniques relevant to cell therapy or biologics.
• Hands-on experience with analytical methods for cell therapy or biologics (flow cytometry, ELISA, PCR, cell culture, cell count/viability, functional assays); familiar with instrumentation/software.
• Demonstrate cross-functional collaboration, flexibility in a evolving environment, and a positive, solutions-oriented attitude.

Responsibilities

• Analytical testing: perform QC testing for cell therapy products per approved methods and SOPs, meeting cGMP, GDP, and ALCOA+ expectations.
• Instrument operation and maintenance: operate, calibrate, and maintain instruments; document activities and escalate issues promptly.
• Documentation and compliance: maintain accurate records and contribute to SOP/test method development; support audits.
• Quality systems: participate in investigations (OOS/OOT, deviations) and support CAPAs and change controls.
• Training and knowledge sharing: complete method qualifications and train peers as needed; ensure analyst proficiency.

Skills

Flow cytometry

ELISA

PCR

Cell culture

Cell counting/viability

Cross-functional collaboration

Education

Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline

Tools

Flow cytometer

ELISA reader

PCR instruments

Job description

Job Description

Role Overview

Rockville, Maryland

The Specialist,QCAnalytical, performs routine and non-routine analytical testing to supportcGMP lotrelease and stability of cell therapy products. The role executes approved methods (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays) with high quality and data integrity,maintainsaccuratedocumentation, 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 positionisfora4days per week, 10 hoursper day shift,Sunday through Wednesday.

Role Responsibilities

Analytical testing:Execute QC testing for cell therapy products (flow cytometry, ELISA, PCR,cell basedassays, cell count/viability) per approved methods and SOPs, meeting cGMP, GDP, and ALCOA+ expectations.

Instrument operation and maintenance:Operate, calibrate, and perform routine maintenance and troubleshooting on relevant instruments; document activities and **escalate** issues promptly.

Documentation and compliance:Maintainaccurate, contemporaneous records in relevant electronic systems and forms; author/review SOPsandtest methods,ensure readiness for internal/external audits and regulatory inspections.

Quality systems:Participatein laboratory investigations (e.g., OOS/OOT, deviations) by gathering data, performing preliminary assessments, and documenting findings; support implementation of CAPAs and change controls.

Training and knowledge sharing: Complete method qualifications andmaintainanalystproficiency; provide peer training on established procedures as qualified.

Planning and teamwork:Coordinate daily testing priorities, sample receipt, and material control with the team; communicate testing status and risks to ensure on-time lot release.

Minimum Requirements

• Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline.

• Minimum of 3years’ experiencewithlaboratory 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.

• Demonstrate effective cross-functional collaboration, embrace flexibility in a constantly evolving environment, andmaintainsa positive,solutions‑orientedattitude to drive outcomes.

• Ability to work on-site in a lab-based rolefor the assigned shift.

The annual base pay (or hourly rate of compensation) for this position ranges from $80,909.60 - $121,364.40.Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.