Quality Control Jobs in AstraZeneca USA
Step into an impactful career supporting digital transformation within advanced cell and gene therapy laboratories. This Specialist Pharmaceutical Quality Systems role empowers life science professionals to drive efficiency, compliance, and innovation across QC operations. Ideal for candidates exploring quality control jobs or seeking growth within a leading global biopharmaceutical company, this opportunity combines technology, compliance, and operational excellence.
About the Company
AstraZeneca is a global, science-driven biopharmaceutical leader committed to delivering life-changing medicines and fostering an inclusive work environment. With a focus on innovation, patient impact, and scientific excellence, AstraZeneca provides rewarding career paths through AstraZeneca careers for professionals in research, manufacturing, quality, and digital transformation. The company champions diversity, equal opportunity, and continuous learning for all employees.
Job Details
- Job Title: Specialist, Pharmaceutical Quality Systems
- Location: Rockville, Maryland
- Job ID: R-241191
- Closing Date: December 14, 2025
Quality Control Job Summary
The Pharmaceutical Quality Systems Specialist supports digital system adoption, integration, and compliance across Quality Control (QC) Cell & Gene Therapy (CGT) laboratory operations. Responsibilities include system onboarding, stakeholder engagement, training, change management, and issue resolution. Core systems include 1Lab, GQCLIMS, MODA, and workflow tools such as Businessmap.
As part of the Laboratory Management & Stability (LMS) team, the role also supports stability program coordination, sample flow oversight, inventory management, and investigation support for OOT/OOS, deviations, CAPAs, and continuous improvement initiatives.
Key Responsibilities
Digital Systems Integration
- Lead onboarding and configuration of QC digital tools.
- Ensure workflows, templates, access roles, and documentation meet operational and compliance requirements.
Stakeholder Collaboration
- Serve as liaison between laboratory teams, IT, QA, and project leadership.
- Gather requirements, align scope, communicate updates, and address system concerns.
Training & Documentation
- Create and deliver training, SOPs, quick reference guides, and controlled templates.
- Conduct readiness assessments and provide post-go-live support.
Issue Resolution & Enhancements
- Troubleshoot system onboarding and usage issues.
- Coordinate incident triage, enhancements, and maintain change/issue logs and feedback systems.
Data Integrity & Compliance
- Ensure GxP-aligned configuration across systems.
- Uphold 21 CFR Part 11/Annex 11 requirements: audit trails, access controls, validation, and traceability.
LMS Core Operations Support
- Support sample flow oversight across QC CGT labs.
- Assist with OOT/OOS, deviations, CAPAs, and stability program activities.
- Maintain inventory management, including Kanban controls, min/max systems, and timely replenishment.
Audit & Inspection Support
- Prepare evidence packages (training, configuration, validation records, change histories).
- Participate in internal and external audits and inspections.
Minimum Qualifications
- Bachelor’s degree in Life Sciences, or related field + 1 year experience with digital lab systems in GMP environments.
- Knowledge of GMP/GxP, 21 CFR Part 11/Annex 11, ALCOA+ principles.
- Experience with 1Lab, GQCLIMS, MODA, Businessmap.
- Proven ability to deliver training, author SOPs, and lead change management for system implementations.
- Strong communication, stakeholder engagement, and cross-functional coordination skills.
Compensation & Benefits of Quality Control Jobs
- Annual base pay: $82,223 – $123,334 (dependent on location, skills, experience).
- Overtime pay for eligible roles.
- Short-term incentive bonus; eligibility for long-term incentive program (salaried).
- Comprehensive benefits:
- 401(k) retirement program
- Paid vacation, holidays, and leaves
- Medical, dental, vision, and prescription coverage
- Employment is at-will; pay and compensation programs may be adjusted based on performance and market factors.
