Senior Specialist Pharmaceutical Quality Systems

AstraZeneca • Rockville, MD

7d • $98,725 - $148,088

About The Position

Senior Specialist Pharmaceutical Quality Systems Summary: The Pharmaceutical Quality Systems Senior Specialist supports Quality Control (QC) cell and gene therapy (CGT) laboratory operations by ensuring the reliability and readiness of laboratory infrastructure. The role emphasizes equipment lifecycle management, cross-functional coordination, and compliant, efficient operations. As part of Laboratory Management and Stability (LMS) team, the role supports shared core responsibilities such as stability program coordination, sample flow oversight, inventory management, and the management of OOT/OOS, deviations, CAPAs, and continuous improvement initiatives.

Requirements

• 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

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.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees