- 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 (Durham, NC)
- …administration engineering group (primarily automation) supporting asset delivery, process development, commissioning, qualification, validation and startup ... supporting systems through user requirements, design, build, commissioning, qualification, validation , and subsequent operation. + Provide leadership and develop… more
- Lilly (Concord, NC)
- … validation , technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing. + 5+ years in pharmaceutical manufacturing ... guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant… more
- Lilly (Durham, NC)
- …detail-oriented Visual Inspection Subject Matter Expert (SME) specializing in parenteral pharmaceutical products. The SME will be responsible for overseeing and ... the internal and external manufacturing network. **Technical Expertise & Process Optimization** : + Serve as the go-to expert...Q standards, Common Q practices, ) and execution documents ( validation reports, PoDs ) to support the visual inspection… more
- EMCOR Group (Raleigh, NC)
- …the country's most versatile and respected providers of environmental rooms for pharmaceutical , biotech, museum, and academic applications. As part of EMCOR Group, ... environmental chambers and laboratory equipment. Execute field-testing, calibrations, and validation testing. Perform preventive maintenance services. Service includes refrigeration,… more
- Lilly (Durham, NC)
- …Previous facility or area start up experience + Previous equipment qualification and process validation experience + Previous experience with SAP or other ... and guidance to site activities (eg, six sigma, new product/ process development, change controls) as material quality SME +...+ Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study + Experience working in… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …objectives to business partners. + Partnering with end-to-end with business process owners, technical solution owners, engineers, and analysts to understand ... Profound grasp of Machine Learning lifecycle - feature engineering, training, validation , scaling, deployment, scoring, monitoring, and feedback loop. + Have… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …summaries, assemble/format submissions in such a manner to facilitate the review process + Inform other departments on new regulatory developments. + Research ... Minimum 4 years of related technical and/or regulatory experience in pharmaceutical industry + Experience with the pre-clinical, clinical, chemistry, manufacturing,… more
- Norstella (Raleigh, NC)
- …our customers come from over 3000 of the world's leading pharmaceutical , contract research organizations (CROs), medical technology, biotechnology and healthcare ... to be a part of Norstella, an organization that consists of market-leading pharmaceutical solutions providers united under one goal: to improve patient access to… more
- Teleflex (Morrisville, NC)
- …chemistry subject matter expert. * Execute testing to support sterilization validation , revalidation, and product change assessments. * Participate in nonconformance ... procedures, ISO standards, and FDA requirements. * May participate in validation for new analytical methods for supporting medical device biocompatibility. *… more