Quality Assurance Officer
Core
Ensure consistent execution of quality standards and regulatory compliance in a GMP environment to enable customer breakthrough discoveries.
Role type
Quality Assurance Officer (Regulated Industry)
Builds
Quality systems, documentation, and compliance frameworks for pharmaceutical/medical device products.
Domain
Life Sciences / Pharmaceutical / Medical Device
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality systems management, GMP compliance, regulatory requirements knowledge, batch record review, SOP management, deviation handling, CAPA execution, quality audit execution, root cause analysis, quality management software proficiency, documentation review, analytical problem solving
Preferred skills
Chemistry/Biology/Biotechnology/Engineering background, Quality Systems or GMP certifications, Lean/Six Sigma methodologies, TrackWise/SAP proficiency, internal/external audit support
Technologies
TrackWise, SAP, Microsoft Office
Responsibilities
Ensure product quality and regulatory compliance in a GMP environment, drive continuous improvement initiatives, collaborate with cross-functional teams, perform detailed documentation review and quality assessments, conduct internal quality audits and support external regulatory audits, execute quality investigations and root cause analysis
Seniority
Individual Contributor
