What are the responsibilities and job description for the QA Validation Specialist 3 position at Spectra Force?
Position Title: QA Validation Specialist 3 Work Location: Portsmouth NH 03801 Assignment Duration: 6 Months Work Arrangement: Onsite Position Summary: Role is Equipment validation and Cleaning Validation. Experience with Kneat is absolutely required. Experience with Ellab for Temp Mapping is a plus. Background & Context: Biopharmaceutical manufacturing operations supporting GMP equipment validation and quality systems in a controlled production environment. Key Responsibilities: • Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment. • Drive/own the validation plans and execution of equipment changes and process improvements. • Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required. • Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state. • Program, organize, and maintain Validation equipment and supplies including dataloggers and probes. • Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Clean-In-Place (CIP), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment. • Develop validation protocols from plans and engineering documents. • Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc. • Perform assigned Quality Systems activities within Document Management System (DMS), TrackWise Quality System (Change Control, Deviation, CAPA). • Perform other duties as assigned. Qualification & Experience: • Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Clean-In-Place (CIP), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment. • Kneat experience is absolutely required for building equipment requalifications and validation activities. • Experience with Ellab for Temp Mapping is a plus.
Salary : $815 - $7,986