Senior Quality Assurance Specialist
Core
Lead complex audits, coordinate external assessments, and manage supplier qualification and risk monitoring for pharmaceutical manufacturing operations.
Role type
Senior Quality Assurance Specialist (Pharmaceutical Manufacturing)
Builds
Pharmaceutical manufacturing site quality oversight and supplier reliability
Domain
Healthcare / Pharmaceutical Manufacturing / Regulatory Compliance
Required skills
cGMP requirements knowledge, risk-based auditing, root-cause analysis, supplier qualification, corrective action evaluation, documentation review, batch record management
Preferred skills
Certified Quality Auditor (CQA), Certified Quality Improvement Associate (CQIA)
Technologies
Microsoft Office tools
Responsibilities
Lead preparation and execution for regulatory inspections and customer audits; Develop risk-based internal audit plans and evaluate systemic compliance risks; Lead risk-based qualification and auditing of critical suppliers; Evaluate root-cause analyses and oversee implementation of corrective action plans; Review quality documentation for accuracy and completeness; Deliver training and coaching on compliance gaps and remediation requirements
Seniority
Senior, hands-on IC
