- UNC Health Care (Lenoir, NC)
- …judgment and coordinates and supervises the activities to maintain FDA /ACR requirements. **Responsibilities** : + Performs quality radiographs on patients ... supervises all quality control tests to meet ACR and FDA requirements for digital mammography. + Ensures all quality...completed within the required parameters of the ACR and FDA . + Uses appropriate device to measure viewbox intensity.… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP BRH ... operations, ensuring alignment with industry regulations such as GxP, FDA , and 21 CFR Part 11. Design scalable, efficient,...comply with relevant Life Sciences industry regulations, including GxP, FDA , EMA, and other regulatory bodies. + Lead the… more
- Perdue Farms, Inc. (Lewiston Woodville, NC)
- …interface with internal, external, customer and regulatory (USDA and/or FDA where applicable) inspectors regarding sanitation related non-conformance reports and ... ensuring strict enforcement of Perdue Farms Standards, USDA, FSIS, FDA , GFSI, OSHA and customer requirements. + Leads or...proven experience in managing Sanitation Programs in USDA / FDA / GFSI regulated facilities. Without degree, must have… more
- IQVIA (Durham, NC)
- …expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use of Patient ... development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED +...regulatory practices, expectations and engagements outside of the US FDA and EMA In addition, take on other leadership… more
- Arc3 Gases (Dunn, NC)
- …direct medical plant operations in compliance with US Food and Drug Administration ( FDA ) regulations to provide quality medical gas products to our customers. The ... plant operators. + Maintain all medical paperwork as per FDA requirements. + Run daily branch automated orders as...training for new and existing employees as required by FDA and Arc3 policies. + Maintain a clean and… more
- J&J Family of Companies (Wilson, NC)
- …Matter Expert (SME) during internal and external regulatory audits (including FDA , EMEA). + Maintains various databases of production and distribution information: ... + Demonstrates expertise in a number of the following areas: cGMPs, FDA regulations, biotherapeutics manufacturing, sampling of raw materials, weigh & dispense of… more
- BD (Becton, Dickinson and Company) (Mebane, NC)
- …Typically requires oversight from a more senior level engineer + ISO compliance, FDA 21 CFR 820 compliance, and cGMP efforts - Understands and has knowledge ... of FDA and ISO regulations and cGMP. Requires oversight from...knowledge and understanding of the Food and Drug Administration ( FDA ) 21 CFR 820 and International Organization for Standardization… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …equivalent Bioworks Certificate or production manufacturing experience in a regulated industry (ie FDA , USDA, NRC) or a 2 or 4 year college degree preferred ... or production manufacturing experience in a regulated industry (ie FDA , USDA, NRC) or a 2 or 4 year...or production manufacturing experience in a regulated industry (ie FDA , USDA, NRC) or a 2 or 4 year… more
- Stryker (Durham, NC)
- …Health & Safety role responsibilities:** + Ensure compliance with OSHA, EPA, FDA , ISO 13485, and company-specific EHS standards. + Develop, implement, and maintain ... facility layouts. + Ensure engineering activities comply with applicable regulations, including FDA 21 CFR Part 820 and ISO 13485. **What you need:** **Required:**… more
- Reckitt (Wilson, NC)
- …/ utility operations. + Serve as automation SME and ensure compliance with GxP, FDA , EU Annex 11, and 21 CFR Part 11 requirements. + Validate and maintain ... technologies for performance optimization. + Drive regulatory alignment (GMP, FDA , ISO, EHS) across automation activities and support audits, validation,… more