Katalyst CRO
Responsibilities
Review and approve the documents required to qualify through the production process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode and Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)). Supplier coordination in support of selection and qualification of new suppliers or changes to existing supplied products and processes. Support, review, and approval of Process Validation (IQ/OQ/PQ), MSA and Control Plan. Route PPAP Checklist in Agile. Leverage GMP (Good Manufacturing Practices) and navigate industry regulations to include FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485, and ISO 14971. PPAP experience; supplier document review and approval per MDT process; supplier control and management; work closely with suppliers. TrackWise and MAP Agile experience. Critical component identification and qualification; perform receiving inspection; driving supplier activities; leadership toward supplier activities and interaction. Qualifications
Good experience in CAPA process. Measurement System Analysis / Test method Validation. Test protocol and report preparation. Seniority
Associate Employment type
Contract Industries
Pharmaceutical Manufacturing Location
Minneapolis, MN
#J-18808-Ljbffr
Review and approve the documents required to qualify through the production process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode and Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)). Supplier coordination in support of selection and qualification of new suppliers or changes to existing supplied products and processes. Support, review, and approval of Process Validation (IQ/OQ/PQ), MSA and Control Plan. Route PPAP Checklist in Agile. Leverage GMP (Good Manufacturing Practices) and navigate industry regulations to include FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485, and ISO 14971. PPAP experience; supplier document review and approval per MDT process; supplier control and management; work closely with suppliers. TrackWise and MAP Agile experience. Critical component identification and qualification; perform receiving inspection; driving supplier activities; leadership toward supplier activities and interaction. Qualifications
Good experience in CAPA process. Measurement System Analysis / Test method Validation. Test protocol and report preparation. Seniority
Associate Employment type
Contract Industries
Pharmaceutical Manufacturing Location
Minneapolis, MN
#J-18808-Ljbffr