Specialist Pharmaceutical Quality Systems
AstraZeneca
Summary
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.
Job description
Key Responsibilities
- Digital Systems Integration: Lead onboarding and configuration of laboratory digital tools across QC processes, ensuring workflows, templates, roles, and access align with operational needs and controlled documentation.
- Stakeholder Collaboration: Act as liaison among laboratory staff, IT, QA, and project leadership to gather requirements, address concerns, align scope, and communicate status and decisions.
- Training & Documentation: Develop and deliver user-focused 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 challenges; coordinate incident triage and enhancement delivery with technical teams; maintain issue/change logs and user feedback loops.
- Data Integrity & Compliance: Ensure GxP aligned configuration and use across systems; uphold 21 CFR Part 11/Annex 11 controls, audit trails, role-based access, validated states, and traceability to URS/FRS/test scripts.
- LMS Core Operations Support: 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.
- Audit & Inspection Support: Prepare evidence packages (training records, configuration summaries, validation status, change histories) and participate in internal/external audits and inspections.
Minimum Qualifications
- Associate's degree with 3 years of relevant experience OR bachelor's degree in Life Sciences, Chemistry, Engineering, Biotechnology, or a related field with at least 2 years of relevant experience
- Experience in GMP laboratory operations, pharmaceutical quality systems, manufacturing support, laboratory digital systems, equipment, materials, sample management, stability, or another regulated technical environment
- Working knowledge of GMP/GxP, data integrity, ALCOA+, and controlled documentation requirements
- Ability to learn and work across multiple LMS processes and laboratory systems, including GQCLIMS, 1Lab, MODA, Businessmap, SAP, or comparable systems
- Demonstrated ability to maintain accurate records, manage concurrent assignments, follow issues through closure, and escalate risks appropriately
- Effective written and verbal communication, stakeholder engagement, and cross-functional coordination skills
Requirements
- Associate's degree with 3 years of relevant experience OR bachelor's degree in Life Sciences, Chemistry, Engineering, Biotechnology, or a related field with at least 2 years of relevant experience
- Experience in GMP laboratory operations, pharmaceutical quality systems, manufacturing support, laboratory digital systems, equipment, materials, sample management, stability, or another regulated technical environment
- Working knowledge of GMP/GxP, data integrity, ALCOA+, and controlled documentation requirements
- Ability to learn and work across multiple LMS processes and laboratory systems, including GQCLIMS, 1Lab, MODA, Businessmap, SAP, or comparable systems
- Demonstrated ability to maintain accurate records, manage concurrent assignments, follow issues through closure, and escalate risks appropriately
- Effective written and verbal communication, stakeholder engagement, and cross-functional coordination skills
Benefits
- 401(k) Retirement Programs
- Paid Time Off
- Vacation & Holiday Leave
- Health Insurance
- Dental Insurance
- Vision Coverage
- Short-Term Incentive Bonuses
- Equity-Based Awards
Company overview
AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.