- Fujifilm (Holly Springs, NC)
- …are manufactured and tested in strict compliance with Good Manufacturing Practices ( GMP ) regulations. You will maintain quality systems that align with CGMP, GDP, ... and process together with monitoring of Quality metrics for GMP Operations + Works with internal teams and clients...and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines. * Experience collaborating… more
- Merck (Durham, NC)
- …calibration, assigned capital project work, and support Good Manufacturing Practice ( GMP ) operations for all facility shutdowns + Coordinates with Site Engineering ... PLC's, VFD's, and automation (BAS) systems in a Good Manufacturing Practices ( GMP )environment. + Must be fully aware of requirement specifications from a… more
- Merck (Durham, NC)
- …Promotion, Micro-IDs, Gas Testing, LIMS, SAP, Trackwise, Investigations with GMP experience. **Education Minimum Requirement:** + Bachelor's degree preferably in ... and Skills:** + EM Sampling in a pharmaceutical setting (not EPA) with GMP experience + Quality Control, Quality Assurance and/or cGMP experience In addition, the… more
- Merck (Wilson, NC)
- …industrial control, measurement, and recording equipment | Prepares accurate GMP acceptable documentation recording measured information for file retention + ... + Accountable for performing assignments in conformance with appropriate Regulatory ( GMP 's) and department standard operating procedures which assure the quality of… more
- Kelly Services (Wilson, NC)
- …by managing and maintaining controlled documents such as SOPs and GMP -regulated materials. + Administer and troubleshoot the site's Electronic Document Management ... teams including Learning & Development to support Good Documentation Practices (GDocP) and GMP training efforts. + Act as a documentation SME during audits and… more
- Lilly (Durham, NC)
- …Process Technician is responsible for providing support and QA oversight to GMP operations in the Warehouse and Logisitics area. The Technician supports multiple ... regular presence in warehouse and logistics areas to monitor GMP programs and quality systems. + Reviews and approves... programs and quality systems. + Reviews and approves GMP documentation in support of daily operations such as:… more
- Amgen (Holly Springs, NC)
- …ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery. Support of engineering and ... environment + Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Downstream… more
- Fujifilm (Holly Springs, NC)
- …ensuring compliance with safety, regulatory, and Good Manufacturing Practices ( GMP ) standards. Additionally, this role also provides training, technical support, ... weather events + Ensures utility systems are operating in compliance with GMP , Occupational Safety and Health Administration (OSHA), and other regulatory standards +… more
- Fujifilm (Holly Springs, NC)
- …timely completion of project milestones and deliverables. This role supports GMP compliant laboratory operations in accordance with regulatory guidelines and ... Plans and DS/DP Specifications. * Authors, reviews, and leads updates of controlled GMP documents related to QC Sample Plans and QC Specifications. * Leads, authors,… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and infrastructure. Candidate will also be required to work autonomously in a GMP environment in addition to being an active contributor to the Production ... procedures and Preventative Maintenance Activities. + Adherence to FDA Regulations, GMP , ISO, HSE (OSHA), Department Procedures, and Manufacturing Directions. +… more