- Biomat USA, Inc. (Research Triangle Park, NC)
- …changes with the potential to impact the safety, purity, potency, and quality of manufactured product are thoroughly reviewed, justified, documented, approved, and ... Responsibilities:** + Ensures compliance with Food and Drug Administration ( FDA ) regulations and all policies, guidelines, and standard operating procedures… more
- ThermoFisher Scientific (Greenville, NC)
- …We are seeking an experienced and meticulous QA Engineer III to join our Quality Assurance team as a Quality Validation Specialist. The ideal candidate will ... have a strong background in quality validation processes, excellent analytical skills, and a dedication to maintaining the highest standards of product quality .… more
- Fujifilm (Raleigh, NC)
- …and processes. + Provides on-going support to resolve application related and image quality concerns on both a product and system level. + Works closely with ... + Ensure compliance with all applicable requirements of the company's quality management system. + Maintains effective communications and working relationships with… 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 ... The QA Engineer, DSM Operations (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during the… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …per approved Manufacturing Directions while maintaining compliance with all job-related SOPs + Quality + Ensure that all batch paperwork is completed in an accurate, ... with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns + Maintain all work areas in a well-organized, clean and… 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 ... + Provide leadership on manufacturing floor ensuring high level of safety, quality , and productivity to maintain reliable supply of products to patients. +… more
- ThermoFisher Scientific (Greenville, NC)
- …skills. + Excellent communication and interpersonal skills. + Proficiency in quality management systems (QMS) and relevant software tools. **Preferred ... + Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines. + Conduct thorough investigations to… more
- Lauridsen Group Inc. (Selma, NC)
- …+ Administers plant training system. + Updates standard operating procedures (SOP's) for quality team. + Complies with and follows company food safety and quality ... prepares for the outgoing mail. + Maintains file for FDA documentation on export shipments. + May be responsible...with Lab responsibilities as needed, including backing up plant Quality Control. + Quality Control Lab Technician… more
- Alaka'ina Foundation Family of Companies (Camp Lejeune, NC)
- …compliance with medical requirements and professional standards in terms of quality and appropriateness. Independent judgment is exercised to determine appropriate ... policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonization (ICH)… 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 ... **Position Overview** The QA Engineer, DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during… more