3 of 3 CAPA Jobs in Cambridge

oversight of lab change control, driving robust impact assessments, document updates, and effectiveness checks that safeguard data integrity and continuity of operations.Issue Investigation and CAPA: Identify, triage, and investigate quality issues, complaints, and non-conformances using root cause analysis; generate and track corrective and preventive actions in partnership with ...

and defend QA processes and documentation to scientists and cross-functional teams Process complaints and nonconformances, ensuring accurate and compliant record keeping Assist in CAPA (Corrective and Preventive Actions) activities Support change control processes and documentation Monitor, evaluate, and report key quality performance indicators (KPIs) related to lab quality Participate ...

Compliance: Embed CAP/CLIA, ISO 15189, ISO 13485, IVDR, HTA and HBS requirements in day-to-day practice, including SOP authorship, deviation/CAPA management, and audit readiness, so our lab remains inspection-ready and trusted.Clinical Trial Testing Support: Perform and oversee prospective diagnostic testing for clinical studies, ensuring ...