Specialist QA
Core
Lead investigations, approve validation protocols and change controls, and manage site quality programs for pharmaceutical and medical device manufacturing.
Role type
Senior IC Quality Assurance Specialist
Builds
Quality assurance programs and validated manufacturing processes
Domain
Pharmaceutical/Biotechnology manufacturing and regulatory compliance
Required skills
Change control management, Validation protocols, CAPA management, Incident investigation, Risk assessment, Lot disposition, Site audit leadership, Regulatory agency interaction, Process validation, Quality program ownership
Preferred skills
NPI experience, Change Control, FATs, Validation, PPQs
Technologies
None stated
Responsibilities
Lead investigations, Lead site audits, Approve process validation protocols and reports, Approve change controls, Provide lot disposition, Review Risk Assessments, Represent QA on NPI team, Approve Environmental Characterization reports, Release of sanitary utility systems, Approve planned incidents, Own site quality program procedures, Request Quality on incident triage team, Review and approve product MPs, Support Automation activities, Support facilities and environmental programs, Review and approve Work Orders, Review and approve EMS/BMS alarms, Approve NC investigations and CAPA records
Seniority
Senior, hands-on IC