- Gilead Sciences, Inc. (Raleigh, NC)
- …**Stakeholder Engagement:** + Work with stakeholders across IT, business operations, quality assurance , and regulatory teams to define and prioritize ... the challenges and regulatory considerations related to batch release, manufacturing, and quality assurance processes. + Familiarity with GxP (Good Manufacturing… more
- Cambrex High Point (High Point, NC)
- …of CAPA plans, Change Requests, and Deviations in coordination with the Associate Director, Quality Assurance + Author and Revise Quality Documents where ... relevant background/leadership in GXP/QA/regulatory compliant pharmaceutical laboratory environment or Quality Assurance /Regulatory Affairs role (prefer late phase/commercial… more
- Fujifilm (Holly Springs, NC)
- …to operational readiness during project phase. This role is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation ... Engineer, DSM Operations is responsible to help drive the Quality oversight for the direction of all Drug Substance...experience * 3+ years of experience working in a GMP regulated environment * Experience in Validation, cGMP manufacturing… more
- WestRock Company (Winston-Salem, NC)
- …based on machine performance. * Liaison with other departments such as quality assurance , warehouse, maintenance, and project coordination to ensure ongoing ... or waste. Includes accuracy, following correct procedures, such as, GMP , SOP, ISO requirements, performing all quality ...as, GMP , SOP, ISO requirements, performing all quality checks, complete and legible documentation. Knowledge of Field… more
- Merck (Wilson, NC)
- …Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product Release, ... Pharmaceutical, Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset. As the primary point of contact for all dealings… more
- Altium Packaging (Mount Airy, NC)
- …training plans and conducts or assigns safety, maintenance, machine operation and quality assurance training to new employees Prepares documentation and provides ... team. Drives compliance with standard operating procedures and policies, such as Safety, Quality , GMP , and CPS. May be assigned to one or more of following… more
- Astellas Pharma (Sanford, NC)
- …and alignment with departmental/site/global goals. + Establish and foster a cGMP quality culture that prepares the site for regulatory pre-approval inspections and ... DI requirements, and/or that remediation and/or mitigation actions are monitored via a Quality System (ie, TWD eQMS, Change Mgmt., etc.) + Assist in the… more
- Fujifilm (Holly Springs, NC)
- …for the Learning & Development team * Uses discretion to make informed quality related decisions for the Learning & Development team * Generates, reviews, and ... 2+ years' experience in a cGMP manufacturing operation and/or Quality oversight, in an FDA regulated facility OR *...0 years' experience * 1-3 years' experience in a GMP environment * Learning Management Software (LMS) experience *… more
- Dairy Farmers of America (Winston Salem, NC)
- …resolve basic to moderate operating difficulties . Collect required samples needed for quality assurance testing . Ensure that the proper packaging materials are ... production line . Complete all required documentation and scheduled quality checks . Monitor weights, seals, caps, and general...safety issues . Follow all DFA good manufacturing practices ( GMP ) and work in a manner consistent with all… more
- Actalent (Clayton, NC)
- …records, logging book entries, documenting work orders, performing process checks for quality assurance , and managing batch packaging records. A tech-savvy ... book entries. + Document work orders and conduct process checks to ensure quality . + Manage batch packaging records for materials. + Identify and report recurring… more