- ThermoFisher Scientific (Greenville, NC)
- …environments. Responsibilities include scaling new processes, supporting product validation and post-approval qualifications, and supporting routine operations to ... mitigation strategies. + Prepare batch records, protocols, and reports for development, validation , and routine production. + Act as technical steward for assigned… more
- Lilly (Concord, NC)
- …the project phase, the Operations Associate (OA) will support commissioning, qualification, and validation of the Parenteral (PAR) areas as well as lead / assist in ... + Understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA, or other similar groups + Excellence in;… more
- Sumitomo Pharma (Raleigh, NC)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- Kelly Services (Winston Salem, NC)
- …development, critical process parameter identification, technology transfer, validation activities, and regulatory submission preparation. Strong collaboration ... adoption of advanced manufacturing technologies. + Plan and execute process validation and qualification studies to meet regulatory and quality standards. Develop… more
- ThermoFisher Scientific (Greenville, NC)
- …Staff Quality Control Environmental Monitoring Engineer will coordinate the validation environmental monitoring (EM) programs within our pharmaceutical manufacturing ... EM programs for cleanrooms and controlled environments. + Coordinate EM validation of air, surface, and personnel samples, including microbiological and particulate… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and mastering manual and automated testing procedures conducted within an FDA regulated GMP/GLP environment. Performs biological testing of moderate to advanced ... of assays and equipment. The incumbent will also support assay validation , method transfer, reagent and control qualification, and laboratory instrument maintenance… more
- Fujifilm (Holly Springs, NC)
- …**Job Description** **What You'll Do** * Manages analytical method transfer and validation activities for cell- and plate-based Bioassays for the QC Analytical ... * Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Performs other duties,… more
- Cytel (Raleigh, NC)
- …support for CMC-related studies, including formulation development, stability studies, process validation , and analytical method validation . + Collaborate with ... + Ensure quality and compliance with internal standards and regulatory guidelines (eg, FDA , EMA, ICH). **Here at Cytel we want our employees to succeed and… more
- Fujifilm (Holly Springs, NC)
- …analytical method TT and execution including method verification, transfer and validation * Interfaces with customers and program management to identify analytical ... * Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Supports the QC… more
- Lilly (Concord, NC)
- …the project phase, the Operations Manager (OM) will support commissioning, qualification, and validation of the Device Assembly and Packaging (DAP) areas as well as ... experience. + Understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA, or other similar groups + Excellence in; electronic,… more