- Merck (Durham, NC)
- …/ AP or US region. **Primary Responsibilities:** + Delivery of best-in-class computer systems validation to capital projects. + Drive the adoption of automation ... coordinate activities across sites. + Ensure compliance with Computer Systems Validation (CSV) and Systems ...appropriate levels of resiliency and performance + Experience in manufacturing analytics systems , including supply and demand… more
- Astellas Pharma (Sanford, NC)
- ** Specialist , QA Validation ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to ... on Astellas, please visit our website at **www.astellas.com** . **The Role** The Specialist , QA Validation will be primarily responsible for the implementation,… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …Hybrid position based out of our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout ... in the development of cGMP operating procedures that relate to process, computer systems , and equipment validation . + Assures compliance with SOPs upon… more
- J&J Family of Companies (Wilson, NC)
- …States of America **Job Description:** Johnson & Johnson is currently seeking a ** Manufacturing Process Specialist ** to join our Johnson & Johnson Innovative ... demand for our current portfolio of medicines and our future innovations. **The Manufacturing Process Specialist ** is a technical expert supporting the … more
- Kelly Services (Winston Salem, NC)
- ** Manufacturing Specialist III - Cell Processing** **Location: Winston Salem NC** **Contract Role, potential to convert but no guarantee** **Hourly Pay Rates: ... performing critical product freezing and storage, and driving continuous improvement. The Manufacturing Specialist III is also responsible for mentoring team… more
- Merck (Wilson, NC)
- …and Validation . **Summary, Focus and Purpose** The Vaccines Technology Specialist position is responsible for providing technical support to primary filling, ... + Familiarity with Change Execution Management tools + Working knowledge with Systems Applications and Products (SAP) / Manufacturing Execution System (MES)… more
- Fujifilm (Holly Springs, NC)
- …approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems * Provides QA oversight and supports DSM operations in ... **Position Overview** The QA Specialist , Drug Substance Manufacturing (DSM) is...of DSM project processes. This role provides oversight of validation program execution for these processes and systems… more
- Merck (Wilson, NC)
- …high liability to projects of varying scopes. Expertise in qualification and process validation practices for complex systems is essential to success in this ... Engineer is responsible for providing technical support of our Manufacturing Division-Wilson packaging and medical device assembly lines. Responsible for… more
- Novo Nordisk (Clayton, NC)
- …GMP practices required + Good knowledge of overall practices for drug product manufacturing , aseptic filling process, quality management systems a plus + Proven ... around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps...of change control systems and Quality Management Systems (QMS) required + Thorough validation knowledge… more
- Fujifilm (Holly Springs, NC)
- …of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable ... **Position Overview** The QA Specialist , Operations is responsible for partnering in the...years' experience in a GMP environment * Experience in Validation , cGMP manufacturing operations and/or Quality oversight,… more