New · posted Oct 19
AstraZeneca · Pharmaceuticals
Specialist, Quality Control Analytical, Cell Therapy
- Rockville, MD
- On-site
- Full-time
- Associate & Specialist
Closes Nov 13, 2026 · 24 days left
The role
Role Overview - Rockville, Maryland
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 (e.g., 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.
Date Posted
18-Oct-2026
Closing Date
12-Nov-2026
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.
What you need
Minimum Requirements
- Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related discipline.
- 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, 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, and maintains a positive, solutions‑oriented attitude to drive outcomes.
- Ability to work on-site in a lab-based role for 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.
What you'll do
Analytical testing: Execute QC testing for cell therapy products (flow cytometry, ELISA, PCR, cell based assays, 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: Maintain accurate, contemporaneous records in relevant electronic systems and forms; author/review SOPs and test methods, ensure readiness for internal/external audits and regulatory inspections.
Quality systems: Participate in 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 and maintain analyst proficiency; 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.
Pay and benefits
$81,000 – $121,000 a year
Employer providedQualified retirement programs
Paid time off
Health coverage
Dental coverage
Vision coverage
Short-term incentive bonuses
Where you'll work
Rockville, MDOn-siteOpen in Maps (opens in a new tab)
More jobs in Rockville, MDJob intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 71% above the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US111 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $81,000 | — | $121,000 |
| All US (middle half) | $48,000 | $59,000 | $76,000 |
This role: AstraZeneca's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 306 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not AstraZeneca's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods9
- Documentation and SOPs6
- Collaboration and leadership5
- Data and digital systems4
- GMP and compliance3
- Investigations and CAPA2
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
Company hiring pulse
AstraZeneca on Regulatory Jobs
- 17
- Open roles
- 14
- Distinct roles
- 7
- Locations
By discipline
- Regulatory10 59%
- Quality7 41%
By level
- Director9 53%
- Associate & Specialist4 24%
- Manager2 12%
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Specialist, Quality Control Analytical, Cell Therapy at AstraZeneca
Applications close November 13. $81K–$121K a year, employer provided.