- Biomat USA, Inc. (Research Triangle Park, NC)
- …based out of our RTP, NC Office.** Ensures current Good Manufacturing Practices ( cGMP ) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, ... review and approval of validation and quality assurance/ control documentation. + Assists in the...control documentation. + Assists in the development of cGMP operating procedures that relate to process, computer systems,… more
- Lilly (Durham, NC)
- …to make life better for people around the world. **Position Overview:** The Quality Assurance - Data Steward is responsible for improving business processes and ... to ensure key business objectives are met. The QA Data Steward represents Quality Assurance on projects, including six sigma. Finally, the QA Data Steward is… more
- Fujifilm (Holly Springs, NC)
- …etc. The QC Chemistry Sr. Analyst 1 adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical ... results and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective...assay performance and assists with implementing improvements that ensure quality and efficiency within QC Chemistry. * Identifies and… more
- ThermoFisher Scientific (Greenville, NC)
- …degree in those fields is highly preferred + 3+ years of experience in Quality Assurance, Quality control or Operations/Manufacturing + 1+ years of ... degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** **POSITION SUMMARY** This QA… more
- Actalent (Winston Salem, NC)
- …operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment ... such as control rate freezers and orbital shakers, performing final product...team members, leading investigations, and ensuring high levels of quality and compliance. Responsibilities + Lead and oversee cell… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …which includes, but is not limited to, the following systems: Document Control , Electronic Quality Management Systems (Investigation, Change Control , ... and major market complaints. Operational Excellence: + Handling of QMS documents like Quality Event/ deviation investigation, Change Control , APR etc. + Review… more
- Lilly (Concord, NC)
- …continuous improvement in deviation writing practices. + Good knowledge of cGMP , regulatory standards, and quality system requirements. Preferred Attributes: ... people around the world. The Deviation Mentor is a key member of the Quality Assurance (QA) team, responsible for teaching, mentoring, and guiding deviation and … more
- Catalent Pharma Solutions (Greenville, NC)
- …systems such as deviation management, analytical investigations (OOS), CAPA and change control . + Demonstrated experience leading Quality Assurance teams in ... **Associate Director, Commercial Quality Assurance** **Position Summary** Catalent, Inc. is a...and support in delivering technical excellence in compliance with cGMP , continuous improvement as well as meets internal business… more
- Kelly Services (Winston Salem, NC)
- …mentoring team members, leading investigations, and maintaining high levels of quality and compliance. **Essential Duties & Responsibilities:** + Lead and oversee ... storage of cell therapy products, ensuring adherence to procedures and maintaining quality standards. + Revise, update, and ensure adherence to SOPs, batch records,… more
- Actalent (Winston Salem, NC)
- …focusing on cell processing activities while ensuring compliance with cGMP guidelines. This position involves operating and maintaining production equipment ... such as control rate freezers and orbital shakers, performing final product...team members, leading investigations, and ensuring high levels of quality and compliance. Responsibilities + Lead and oversee cell… more