QA Compliance Specialist - LSA
Core
Ensures adherence to GMP regulations and internal quality standards by supporting Quality Systems and Compliance programs.
Role type
QA Compliance Specialist
Builds
Quality systems activities, inspection readiness, and compliance reporting
Domain
Pharmaceutical manufacturing / Life Sciences / GMP
Deliverable
dashboards & analysis
Required skills
GMP regulations knowledge, deviation management, CAPA handling, change control, investigation support, regulatory inspection readiness, quality metrics tracking, SOP development, cross-functional collaboration
Preferred skills
eQMS platforms (TrackWise, Veeva, MasterControl), Life Sciences degree
Responsibilities
Support Quality Systems activities including deviations, CAPAs, change controls, investigations, and quality risk management; Review quality records and documentation for GMP compliance; Assist with inspection readiness for regulatory inspections, customer audits, and internal audits; Track, trend, and report Quality Metrics, KPIs, and compliance indicators; Collaborate with cross-functional teams to identify compliance gaps and support corrective actions; Provide GMP guidance to operational groups; Assist with SOP development and management.
Seniority
Mid-level, hands-on IC
