Investigation & Client Quality Specialist
Core
Ensure product quality, drive continuous improvement, and maintain GMP compliance in a quality assurance team.
Role type
Quality Assurance Specialist (Regulated Industry)
Builds
Quality systems and documentation 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
cGMP knowledge, ISO standards (13485/9001), quality system documentation, batch records, SOPs, deviations, CAPA, quality management software (TrackWise, SAP), root cause analysis, internal/external audit support, Lean/Six Sigma
Preferred skills
Chemistry/Biology/Biotechnology/Engineering background, Quality Systems/GMP certifications, continuous improvement methodologies
Technologies
TrackWise, SAP, Microsoft Office
Responsibilities
Perform detailed documentation review and quality assessments, conduct internal quality audits, support external regulatory audits, collaborate with cross-functional teams to maintain quality standards
Seniority
Individual Contributor
