- Lilly (Durham, NC)
- …enhancing our visual inspection program and processes to ensure the highest quality standards. The ideal candidate will provide expert guidance on inspection ... technical knowledge, strong analytical skills, and a commitment to product quality and patient safety. **Key Responsibilities** : **Visual Inspection Program… more
- Kelly Services (Greenville, NC)
- …in deviation management, QA, or quality systems in a pharmaceutical or GMP -regulated environment. + Solid understanding of FDA , EMA, and ISO regulatory ... from standard operating procedures, protocols, or regulatory requirements within a GMP -regulated environment. This role plays a key part in ensuring compliance… 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 ... stakeholders in Quality , Engineering, MSAT, Operations, Automation, IT, and other departments...designed to ensure facilities, utilities and equipment used for GMP production are fit for purpose and operate in… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …ability to work as part of a team with minimal supervision. + Knowledge of FDA and/or GMP regulations preferred. + Prior ERP experience preferred. + Prior ... improvement efforts through the use/implementation of documentation innovation and quality related processes; thereby aligning and consolidating procedural documents… more
- BD (Becton, Dickinson and Company) (Mebane, NC)
- … role in Life Sciences, biotechnology, or related industries. * Experience working under GMP , regulated industries by FDA . or/and ISO 13485 is desirable. * ... necessary to support a change. * Troubleshoots and investigates quality and process issues within the manufacturing or QC...Sciences, biotechnology, or related industries. + Experience working under GMP , regulated industries by FDA . or/and ISO… 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 ... and production of material promptly and with the highest quality standards. + Maintain documentation and functional work areas...standards. + Maintain documentation and functional work areas to GMP standards. + Capable of lifting and moving heavy… more
- Lilly (Durham, NC)
- …utilization. + Follow all GMP , and other regulatory requirements. Participate in quality initiatives and audits. Compliance to FDA , EMEA, DEA, OSHA, IDEM, ... working safely and accountable for supporting all HSE corporate and site goals. + Quality experience with a safety first and quality always mindset. + Support… more
- Actalent (Winston Salem, NC)
- …tasked with supporting laboratory instrumentation and computerized systems within a GMP -regulated environment, with an emphasis on data integrity. This position ... are implemented and maintained in compliance with data integrity principles, GMP regulations, and internal policies. + Manage qualification, validation, and periodic… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles ( GMP /GLP). + Experience with chemistry or biochemistry ... 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… more
- Lilly (Concord, NC)
- …with 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...Strong interpersonal and communication skills + Solid understanding of quality and corporate policies + Solid understanding of the… more