When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
- Provide quality decision making support and guidance to the QC and Manufacturing inspection process.
- Communicates shift activities to Quality Management and QC Group Leaders, providing details for quality issues and NCR occurrence. This includes recommending follow-ups and actions needed as a result of the non-conformance review.
- Manage Non-GMP lot file control and movement with the various work centers to product release.
- Inspect and follow QC procedures in compliance with ISO/GMP requirements including QA specifications, STP’s, blueprints and other engineering specifications.
- Set up and use all QC Department measuring and testing equipment, as well as identify equipment that is not in proper working condition.
- Supplier NCR and RGA management including facilitating the assignment of tasks and follow through to completion, review of the final paperwork for completeness and accuracy, and closing of the NCR.
- Be able to communicate inspection findings with appropriate personnel in the Quality, Manufacturing and Engineering departments. Participate in corrective action activities.
- Perform internal audits of the Quality management system in accordance with ISO13485 and 21CFR part 820.
- Support corrective actions as a result of audit findings, follow-up and ensure compliance.
- Provide support to both Penfield and Fairport facilities.
- Minimum of a H.S. Diploma or GED. A two year degree in technology or certification by ASQ is a plus
- Previous leadership experience is a plus
- At least 5 years of QC inspection experience in a ISO/GMP system
- Proficient in SAP QM system
ISO Auditor certification (If not certified, certification must be obtained within 2 years of employment)
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