- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- The Director, Global Product Quality , GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing global ... quality systems are aligned with **Good Manufacturing Practices ( GMP )** and regulatory requirements while driving **efficiency, consistency, and continuous… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …of product standards and extensive pharmaceutical experience preferably in manufacturing, quality assurance, and/or GMP auditing and demonstrated project ... extensive experience as a related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing and demonstrated project management… more
- Herbalife (Winston Salem, NC)
- …Experience with food, supplement or pharmaceutical manufacturing + Knowledge and understanding of GMP quality systems At Herbalife, we value doing what's right. ... of production materials to released, rejected, hold, etc. + Document quality -related incidents using appropriate GMP documentation (eg, nonconforming materials… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …as well as drive continuous improvement. **Job Description** + Responsible for directing quality oversight of GMP contract manufacturers of Otsuka clinical and ... **Job Summary** The Associate Director, Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial products at… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …a controlled way that is in accordance with regulatory expectations and applicable GMP /GDP quality standards. This role will provide specialized Biologics ... bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible… more
- Astellas Pharma (Sanford, NC)
- …such as Standard Operating Procedures (SOPs), specifications, protocols, and reports for Quality and GMP -related functions. + Author, review, and approve ... **Specialist, Quality Assurance for QC** Do you want to...website at www.astellas.com . **Purpose and Scope:** The **Specialist, Quality Assurance for QC** will be responsible for providing… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …well as drive continuous improvement. **Job Description** + Responsible for directing quality oversight of GMP contract manufacturers of controlled substances ... **Job Summary** The Associate Director Controlled Substances, Quality Global Product Quality - API/DP...batch record review and release process for + OAPI GMP release of Contract Manufacturers operations supporting clinical and… more
- Lilly (Durham, NC)
- …product related issues. + Provides guidance in operational areas to ensure robust Quality Systems and GMP compliance (documentation review, gap assessments and ... on our exciting future. As a result, Lilly is looking for experienced Quality Assurance Sr. Principal Scientist to support our growth in Research Triangle Park… more
- Fujifilm (Holly Springs, NC)
- … Risk Management principles **Preferred Requirements:** * 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility * ... and tested in strict compliance with Good Manufacturing Practices ( GMP ) regulations. You will maintain quality systems...Manufacturing Practices ( GMP ) regulations. You will maintain quality systems that align with CGMP, GDP, and other… more
- Amgen (Holly Springs, NC)
- …in a regulated environment (eg cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and ... Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors. + System guidance to… more