Specialist Pharmaceutical Quality Systems

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

• 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 postgolive 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.