- Merck (Durham, NC)
- …, including successful completion of engineering runs, clinical batches, successful process validation , and maintaining alignment with the sending/partner sites ... responsible for tactical and strategic decisions related to tech transfer and process stabilization. The Associate Director will ensure optimized product quality and… more
- Fujifilm (Holly Springs, NC)
- …Management * Prior drug substance or manufacturing experience, including process validation , transfer, commercialization, and manufacturing support and ... manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This role interfaces with customers and… more
- Kelly Services (Morrisville, NC)
- …team members as needed. + Support cross-functional teams in equipment qualification, process validation , and deviation investigations. + Participate in routine ... hands-on aseptic processing, equipment setup and maintenance, and participation in process improvements within a GMP-compliant environment. The ideal candidate will… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …level Positions) + Perform the Tracking System Deployment for Stability Samples/ Process Validation Samples etc. + Perform the Training Tracking Tool/Software ... procedures and systems for RM, PM, FD and in process testing in QC lab. Provide information, data for...transfer of analytical methods for new products. Execute cleaning validation of new products. + Assist in the monitoring… more
- Lilly (Concord, NC)
- …+ Facility, Equipment, Systems Start-up + Equipment design, qualification, and process validation . + Manufacturing Execution Systems and electronic batch ... project phase, the Operations Associate (OA) will support commissioning, qualification, and validation of the Device Assembly and Packaging (DAP) areas as well as… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …of QC staff + Perform the Tracking System Deployment for Stability Samples/ Process Validation Samples etc. + Perform the Training Tracking Tool/Software for ... procedures and systems for RM, PM, FD and in process testing in QC lab. Provide information, data for...transfer of analytical methods for new products. Execute cleaning validation of new products. + Assist in the monitoring… more
- Lilly (Concord, NC)
- …facility or area start up experience + Previous equipment qualification and process validation experience + Previous experience with highly automated syringe ... capability, for a diverse leadership and quality assurance staff to support qualification, validation and routine production + Manage a team of up to approximately… more
- Insight Global (Marion, NC)
- …-Ensure compliance with FDA, ISO, and GMP regulations throughout the validation process . -Coordinate with cross-functional teams (engineering, quality assurance, ... our medical device manufacturing facility. This role will work closely with Validation Engineers to develop and maintain project schedules, ensuring timely execution… more
- Lilly (Concord, NC)
- …C&Q / Verification and Validation oversight including automation and computer systems validation + Use process knowledge and control strategy to make quality ... better for people around the world. **Responsibilities:** The Quality Assurance Process team member is responsible for demonstrating leadership, teamwork, and… more
- Corning Incorporated (Wilmington, NC)
- …manufacturing new and advantaged products and processes; design and execute product or process validation tests in a manufacturing plant; analyze data, draw ... improve and industrialize Optical Fiber manufacturing platforms (platform = process + equipment) for revolutionary manufacturing processes, thereby enabling… more