Quality Specialist
Core
Independent quality assurance oversight for the site's Quality Control Laboratory and contract labs, ensuring timely approval of laboratory investigations, analytical method transfers, and Certificate of Analysis (CoA) reviews.
Role type
Quality Specialist (QA/QC)
Builds
Quality assurance documentation and approvals for pharmaceutical manufacturing
Domain
Healthcare / Pharmaceuticals / Generics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EU GMP knowledge, analytical method transfer coordination, supplier investigation evaluation, CoA review, documentation approval, problem-solving, GMP compliance
Preferred skills
TrackWise, LIMS, Empower software usage, C1 level language proficiency
Technologies
TrackWise, LIMS, Empower
Responsibilities
Ensure timely and proper approval of laboratory investigations per SOPs; Support supplier investigation evaluation and approval; Review and ensure availability of Certificates of Analysis; Coordinate Elemental Impurity measurements; Ensure GMP principles are adhered to; Participate in GMP-related training for staff
Seniority
Mid-level, independent contributor
