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Kelly Science, Engineering, Technology & Telecom · 2 days ago

Senior QA Associate

Petaluma, CA

Full-time

Onsite

Senior Level

5+ years exp

Kelly Engineering is committed to advancing solutions for challenging issues in healthcare. The Senior QA Associate will assist in leading the Quality Assurance department, ensuring compliance with pharmaceutical regulations and driving quality processes for product launches.

Staffing & Recruiting

Responsibilities

Assist the QA Manager in building, scaling and managing the QA team

Ensure regulatory compliance with GMP, FDA, ISO13485 and combination product requirements

Assist in launch readiness and quality activities to meet urgent product timelines

Develop and implement SOPs, validation protocols, and quality documentation systems

Assist in audit and inspection preparation

Drive root cause analysis, CAPA programs, and continuous improvement

Engage with R&D, manufacturing, and regulatory teams to align quality and business goals

Qualification

FDA regulationsISO standardsGMP complianceQuality Assurance experienceSOP developmentRoot cause analysisCAPA programsContinuous improvementAudit preparationTeam management