Quality Assurance Analyst
Core
Ensure daily manufacturing operations comply with cGMP and ISO 9001 requirements, acting as the first point of contact for production issues and compliance questions.
Role type
Quality Assurance Analyst (Manufacturing)
Builds
GMP-compliant pharmaceutical/chemical production batches and validated processes
Domain
Life Sciences / Chemical Manufacturing
Required skills
GMP regulations knowledge, deviation investigation, change control management, validation documentation review, batch disposition, audit support, process startup oversight, continuous improvement project participation
Preferred skills
Chemistry or engineering background, SAP and TrackWise experience, 3-5 years industrial experience in GMP environment
Technologies
SAP, TrackWise, Microsoft Office
Responsibilities
Provide or approve initial assessments for all quality events; Review and approve minor deviations and change controls; Review validation documents; Disposition GMP API and final intermediate batches; Ensure adherence to site cleaning program; Approve Master Production Records; Provide oversight for audit-related activities; Contribute to continuous improvement via project teams; Provide backup support for customer audits and regulatory inspections (via careerplan.io/jobs/R52014-1-quality-assurance-analyst-at-evonik)
Seniority
Mid-level, hands-on IC
