Lead Specialist QA Quality Systems, Quality - 1st Shift
Core
Lead complex/critical investigations, trends, and CAPA actions while overseeing site quality systems and supporting external audits in a GMP environment.
Role type
Senior IC Quality Systems Specialist (GMP)
Builds
Investigation reports, CAPA actions, quality metrics, and compliance documentation for pharmaceutical manufacturing.
Domain
Healthcare / Pharmaceutical Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, cGMP standards, change control, statistical analysis, technical writing, cross-functional problem solving, audit support, continuous improvement, CAPA management, deviation triage, quality system oversight
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead complex/critical investigations and propose CAPA actions; Represent QA in deviation triage and containment; Facilitate cross-functional structured problem solving; Compile and analyze data for Annual Product Reviews and Management Reviews; Perform Periodic Quality Reviews (PQRs); Provide oversight for potentially critical complaints; Lead periodic and special cause trending assessments; Provide leadership for assigned elements of the Site Quality System; Lead continuous improvement project teams; Approve laboratory investigations and incidents; Serve as Site Contact for Global Quality Initiatives; Support external audits and health authority inspections; Mentor and train Quality Systems Specialists
Seniority
Senior, hands-on IC
