Lead / Senior Specialist, QA (External)
Core
Lead and support daily Quality Assurance activities in a biopharmaceutical manufacturing facility, ensuring compliance with GxP requirements and driving continuous quality improvement.
Role type
Senior IC Quality Assurance Specialist (Biopharmaceutical Manufacturing)
Builds
High-quality, safe medicines for global customers
Domain
Life Sciences / Biopharmaceuticals / GMP Manufacturing
Required skills
GxP compliance, deviation investigation, change control, CAPA management, data integrity, regulatory inspection support, material release, vendor investigation, project management, GMP facility operations
Preferred skills
None stated
Technologies
None stated
Responsibilities
Support daily QA activities in compliance with approved SOPs, policies, and cGxP requirements; Review and approve SOPs, protocols, reports, and quality records; Lead deviation investigations, change controls, CAPA plans, and troubleshooting activities; Ensure data integrity and drive continuous quality improvement; Support and lead regulatory inspections, customer audits, and audit responses; Perform material release, qualification, defect inspections, and review vendor investigation reports; Lead projects, manage deliverables, and coordinate cross-functional activities; Maintain strong stakeholder relationships and develop training and internal GxP auditing competencies; Participate in facility walkdowns and perform other duties as assigned.
Seniority
Senior, hands-on IC