AstraZeneca · 8 hours ago
Senior Specialist Pharmaceutical Quality Systems
Rockville, MD
Full-time
Onsite
Mid, Senior Level
$99K/yr - $148K/yr
6+ years expAstraZeneca is a leading pharmaceutical company, and they are seeking a Senior Specialist in Pharmaceutical Quality Systems to support Quality Control laboratory operations. The role involves managing laboratory infrastructure, coordinating cross-functional teams, and ensuring compliance with quality standards.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Manage laboratory infrastructure, utilities, and maintenance programs to ensure operation efficiency
Own preventive maintenance and calibration schedules; manage qualification status (IQ/OQ/PQ), lifecycle tracking, service history, and audit readiness
Interface with Facilities, Validation, and IT to address utilities, environmental monitoring, instrument integration, and computerized system support while maintaining QC ownership of readiness
Schedule, escort, and oversee external service vendors; ensure safety, GMP compliance, and complete service documentation
Admin/power user for GQCLIMS, 1Lab, Businessmap, and MODA
Support sample flow oversight across QC CGT labs; assist with investigations for OOT, OOS, deviations, and CAPAs; contribute to stability program; and maintain inventory management processes including Kanban room controls, min/max levels, and timely replenishment to sustain compliant operation
Prepare evidence packages (training records, configuration summaries, validation status, change histories) and participate in internal/external audits and inspections
Qualification
Required
High School Diploma and 10 years of experience or Associate's degree and 8 years of experience OR Bachelor's in Life Sciences, Engineering, or related field and 6 years' experience in GMP laboratory operations (CGT/biologics preferred); experience with equipment qualification and computerized system compliance
Strong knowledge of 1Lab, GQCLIMS, MODA, and Businessmap
Strong knowledge of GMP/GxP, 21 CFR Part 11/Annex 11, and ALCOA+
Audit/inspection support experience
Demonstrated vendor management and cross-functional coordination
Excellent stakeholder engagement, communication, and issue management
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
H1B Sponsorship
AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Essential Business
2026-01-24
2026-01-23
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