- Kelly Services (Winston Salem, NC)
- …Regulatory CMC (Contractor)** to provide specialized support for Chemistry, Manufacturing , and Controls (CMC) compliance and documentation activities. This ... and analyze technical data from QA, QC, and Manufacturing teams to support regulatory filings. + Ensure that all documentation aligns with regulatory… more
- Merck (Durham, NC)
- …cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP) + Demonstrated ability to work both independently and as ... **Job Description** **Job Description** Our Manufacturing Operations teams are the people that make...facility. + Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering… more
- Fujifilm (Holly Springs, NC)
- …as the subject matter expert (SME) and provides technology transfer support , technical oversight, and strategic input for Process Analytical Technologies (PAT). ... 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging… more
- Merck (Durham, NC)
- …pharmaceutical manufacturer? If so, then this is the opportunity for you! Our Manufacturing Division is a team of dedicated, energetic individuals who are committed ... external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply… more
- Fujifilm (Holly Springs, NC)
- …with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess ... maintaining compliance with quality standards + Provides comprehensive QA oversight and support for manufacturing operations and associated support functions… more
- GE Vernova (Wilmington, NC)
- …shift. + Develop and support the growth of all team employees. + Support manufacturing leaders in the strategic planning of staffing, equipment, and other ... Ensure team members are provided adequate training, resources and support to assure safe manufacturing practices in...Power Point, Excel, Outlook) + Ability to interpret engineering documentation , such as PIDs + Nuclear plant operations or… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …and other regulatory bodies. + Lead the development of validation strategies and documentation to support compliance efforts. **Integration with SAP & Non-SAP ... SAP systems, working closely with cross-functional teams to enhance manufacturing processes, quality management, and overall system integration. **Strategic Solution… more
- Merck (Durham, NC)
- …all required processing equipment, materials, supplies and products needed to support manufacturing . + Operates various computer-controlled process support ... and manufacturing operations. The individual in this position will support the vaccine manufacturing process through hands on processing activities.… more
- Fujifilm (Holly Springs, NC)
- …work experience; or + PhD with no prior experience + Large scale manufacturing support experience with chromatography for several types of chromatographic ... documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports,… more
- Merck (Durham, NC)
- **Job Description** Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality ... work in the local plant connected to our global manufacturing network to ensure the highest quality of raw...others and contribute to process improvements. This position will support the vaccine drug substance site readiness through licensure… more