- Univar Solutions (Jamestown, NC)
- …+ Assist in gathering data and preparing branch prior to external Compliance and Quality Audits (Customer, Supplier, FDA or other Agencies, and Associations) + ... your career in areas that energize and excite you. Quality Assurance Technician WHAT YOU'LL DO: + Execute individual...WHAT YOU'LL DO: + Execute individual responsibilities toward branch quality systems aligned with Corporate Quality , Industry… more
- System One (Raleigh, NC)
- …related field (preferred) + 3+ years of pharmaceutical/biotech working experience in Quality Assurance in an FDA -regulated industry. + Experience with batch ... Job Title: Quality Associate Location: Raleigh, NC Type: Contract Overview The Quality Associate, will play a key role in supporting data migration, batch record… more
- Eliassen Group (Raleigh, NC)
- …develop corrective actions + Ensure all written materials align with company, quality , and FDA guidelines across all manufacturing components **Experience ... Requirements:** + Ability to manage competing priorities + Overall understanding of process instructions + Life Science Experience + Software Skills Required: MS Platform Suite, Oracle, Coupa + Functional knowledge of Engineering/Maintenance + Maximo or Asset… more
- Teleflex (Morrisville, NC)
- …by facility requirements. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device ... driven by our purpose to improve the health and quality of people's lives. Through our vision to become...totally Customer Centric in our unrelenting focus on Improving Quality , Service and Value as perceived by our customers.… more
- Fujifilm (Holly Springs, NC)
- …leadership, and team management experience * Experience in cGMP manufacturing operations and/or Quality role in an FDA /EMA regulated facility. * Experience and ... for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations....Substance Operations. In this role, you will oversee our Quality Product and Validation teams, along with the batch… more
- Fujifilm (Holly Springs, NC)
- … Assurance and/or similar role * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. * High level of ... DSM Operations (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance...the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams.… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …of our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA /Grifols Quality Systems are adhered to throughout the evaluation, review and ... approval of validation and quality assurance/control documentation. + Assists in the development of...additional corrective actions as required. + Communicates with Field Quality /Operations and other Operational and Quality Assurance… more
- Fujifilm (Holly Springs, NC)
- …experience in a GMP environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. * High level of ... QA Engineer, DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance...operational readiness. The QA Engineer, DSM is responsible for quality assurance oversight of day‐to‐day activities and resolution or… more
- Lilly (Durham, NC)
- …+ Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) and other ... with cross-functional business partners in Supply Chain, Engineering/Process Automation, Quality , Operations, Learning & Development, and global counterparts to… more
- Fujifilm (Holly Springs, NC)
- …a GMP environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility **Preferred Requirements** * ... Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of… more