- 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 mentors other associates within maintenance and operations. + Monitor output quality and quantity; troubleshoot as needed to make necessary machine and parameter… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …manufactured products are appropriately measured and monitored according to Glenmark Monroe quality system requirements and regulatory guidelines (eg, FDA 21 ... Microbiology/EM Team Lead provides direct oversight and guidance in the Quality Control Microbiology and Environmental Monitoring (EM), including applicable support… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices. In addition, personnel in this position ... specific batch records. - Maintain documentation and functional work areas to GMP standards. - Communicates effectively to area leadership and all cross functional… 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 ... author and refine SOPs, batch documents, and standard work instructions, setting clear quality and safety standards from day one. You will help recruit, schedule,… more
- J&J Family of Companies (Wilson, NC)
- …for performing manufacturing procedures and the execution of scheduled tasks within a GMP environment. This position is responsible for quality and maintaining ... + Accurately complete documentation in SOP's, logbooks and other GMP documents and/or systems. + Maintain equipment and instruments....with all state and federal regulations and guidelines including FDA , EPA and OSHA. + Adhere to the safety… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …enhance equipment reliability and efficiency + Ensure all maintenance activities comply with FDA regulations, GMP , ISO standards, and safety protocols + Utilize ... skills (written & verbal). 7. Strong attention to detail and GMP experience (including knowledge of change control, validation, and commissioning processes)… more
- Fujifilm (Holly Springs, NC)
- …Sciences or Engineering and without any experience * 3+ years of experience in GMP Quality Assurance and/or similar role * Experience in Validation, cGMP ... manufacturing operations and/or Quality oversight, in an FDA regulated facility. * High level of familiarity/understanding of validation of production equipment,… more
- Lilly (Concord, NC)
- …adequately staffed with trained & qualified employees. Strict adherence to safety and quality rules and procedures is expected. Direct line supervision for this role ... leadership on manufacturing floor ensuring high level of safety, quality , and productivity to maintain reliable supply of products...2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + STEM… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines. + Conduct thorough investigations to ... documentation is completed following Good Documentation Practices (GDP). **Compliance and Quality Assurance:** + Ensure all deviations are managed in compliance with… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …learning and mastering manual and automated testing procedures conducted within an FDA regulated GMP /GLP environment. Performs biological testing of moderate to ... by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols' activities focus on fulfilling the needs of its… more