- Astellas Pharma (Sanford, NC)
- …assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, ... functions to instill a 'Quality Culture' by coaching in the application of GMP principles including the underlying rationale of those principles. + Author, review… more
- Lilly (Durham, NC)
- …staff, focusing on the visual inspection of parenteral products and adherence to GMP requirements. + Mentor junior staff and develop training materials to promote ... organization. **Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by...+ 10+ years of experience with parenterals in a GMP -regulated environment, with at least 5+ years of experience… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …following standard operating procedures (SOP) and batch records in accordance with FDA current Good Manufacturing practices (cGMP). In addition, personnel in this ... the highest quality standards. + Maintain documentation and functional work areas to GMP standards. + Capable of lifting and moving heavy equipment parts and… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …working a 2-2-3 rotation schedule. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry ... a timely manner. + Maintains compliance with SOPs, GLP, GMP , and HSE requirements. + Prepares for regulatory, customer,...Experience participating in the management of regulatory audits (ie FDA , MDSAP, ISO, OSHA, EPA, etc.). + Experience in… more
- Lilly (Concord, NC)
- …Leader and safety representatives to implement safety projects. + Follow all GMP , and other regulatory requirements. Participate in quality initiatives and audits. ... Provides leadership for compliance to FDA , OSHA, EPA regulations. + Identifies and implements performance...Minimum 3+ years of Previous warehouse/logistics experience in a GMP environment + SAP/EWM experience a plus + DOT… more
- J&J Family of Companies (Wilson, NC)
- …QA teams to ensure that accurate impact assessment is determent and site GMP guidelines followed. The CVS Automation Engineer for Johnson & Johnson Innovative ... on the project is conducted to a consistently high standard, following JNJ and GMP guidelines + Support C&Q team during commissioning on various CSV topics + Drive… more
- Fujifilm (Durham, NC)
- …design and implementation of a global, harmonized C&Q/OR program across all FB GMP manufacturing facilities. The role will work closely with global and site ... C&Q/OR standards and procedures designed to ensure facilities, utilities and equipment used for GMP production are fit for purpose and operate in a state of control.… more
- ThermoFisher Scientific (Greenville, NC)
- …and client requirements. Sr Director will engage with key global regulators to include FDA , EMA, and ANVISA; and identify mechanisms to assure that our practices and ... effective products and make Quality a competitive advantage by achieving outstanding GMP regulatory compliance with zero patient impacting events and drive quality… more
- Corning Incorporated (Durham, NC)
- …+ Minimum of 6 years' experience with equipment maintenance in an FDA compliant manufacturing environment. + Specific work experience required in use of ... and good documentation practices per company and Good Manufacturing Practice ( GMP ) standards. + Maintain clean tooling for extruders, injection molding equipment,… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... goal‑setting, and open communication to hit daily deliverables and maintain GMP compliance. You will collaborate closely with QA, warehouse, manufacturing, and… more