QA Validation Specialist 3
eTeam Inc.Portsmouth, NH
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Overview
Remote
On-site
Job Description
Title: QA Validation Specialist 3Location: Portsmouth, NHDuration: 6 monthsDescription:
- Experience with Kneat is absolutely required. Experience with Ellab for Temp Mapping is a plus
- Manager is looking for candidates with Cleaning Val (CIP, COP, SIP). 95% of equipment is Single Use, so the Cleaning Val is limited mostly to Media Hold/Media Fill. Cleaning Val is mostly Drafting SOPs
- Other equipment includes Autoclaves, Parts Washers, and Storage equipment (cold and ambient). Looking for the worker to Build Equipment Re-qualifications in Kneat.
- 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.
- Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated states.
- 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.
- Program, organize, and maintain Validation equipment and supplies including dataloggers and probes
- Develop validation protocols from plans and engineering documents.
- Perform assigned Quality Systems activities within Document Management System (DMS), TrackWise Quality System (Change Control, Deviation, CAPA)
- Perform other duties as assigned.
- Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc.
- Job Summary: Equipment Validation Analyst Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
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FAQs About QA Validation Specialist 3 Jobs at eTeam Inc.
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This job at eTeam Inc. is located in Portsmouth, NH, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at eTeam Inc.?
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