- Kelly Services (Greenville, NC)
- …Management:** + Identify, log, and manage deviations related to SOPs, quality standards, or regulatory requirements. + Lead investigations to determine root ... all documentation complies with Good Documentation Practices (GDP). **Compliance and Quality Assurance:** + Ensure deviation management aligns with internal SOPs,… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The QA Project Manager, Program Quality Assurance (PQA) is responsible for providing the PQA team with assistance and oversight of QA projects. ... in accordance with governing processes + Ensures project and operational quality objectives are met within desired timelines, contributing to team success… 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 ... manufacturing lines. + Maintain the MES system architecture (platform, software , interfaces, and client virtualization tools) by coordinating lifecycle management,… more
- Lilly (Concord, NC)
- …adequately staffed with trained & qualified employees. Strict adherence to safety and quality rules and procedures is expected. Direct line supervision for this role ... / Deliverables:** **Integrity** + Leading by examples with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority"… more
- Fujifilm (Durham, NC)
- …The role will work closely with global and site stakeholders in Quality , Engineering, MSAT, Operations, Automation, IT, and other departments to develop, implement ... risk-based qualification strategy aligned with industry guidance, the position ensures quality outcomes and compliance with health regulations to support the… 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
- Kelly Services (Winston Salem, NC)
- …process improvement initiatives focused on enhancing productivity, yield, and product quality through adoption of advanced manufacturing technologies. + Plan and ... execute process validation and qualification studies to meet regulatory and quality standards. Develop control strategies for critical process parameters (CPPs) to… more
- Fujifilm (Holly Springs, NC)
- …regulated environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. **Preferred ... Overview** The QA Engineer, DSM Operations is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes… 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:** * ... The QA Specialist, Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight… more
- ARAMARK (Cullowhee, NC)
- …directors on execution of special diets and meal plan accommodations, quality assurance programs and food service production. **Job Responsibilities** + Supports ... related to their specific needs. + Oversees compliance for FDA menu labeling laws. + May use nutrition analysis... menu labeling laws. + May use nutrition analysis software to analyze ingredients, products, and recipes. + Stays… more