Quality Assurance Specialist m/f/d
Core
Coordinate, review, and process quality events, deviations, nonconformances, complaints, CAPAs, and change controls using MasterControl eQMS in a biopharma operations setting.
Role type
Quality Assurance Specialist (Operations)
Builds
Quality system compliance and operational integrity for biopharma clients
Domain
Biopharmaceuticals / Quality Management
Deliverable
dashboards & analysis
Required skills
GMP knowledge, MasterControl eQMS, CAPA management, Change Control management, SOP authoring, Risk analysis, Data metrics reporting
Preferred skills
Science degree (Chemistry/Pharmacy/Biology), 2+ years QMS experience, QM software experience
Technologies
MasterControl, MS Office (Excel, Word, Outlook)
Responsibilities
Coordinate and process events, deviations, nonconformances, complaints, CAPAs, and change controls; Draft, review, and update SOPs and work instructions; Support risk analyses and validation activities; Prepare quality system metrics and monthly statistics; Assist with customer audits and regulatory inspections.
Seniority
Junior to Mid-level, individual contributor
