- GRAIL (Raleigh, NC)
- …to Standard Operating Procedures, Work Instructions, and Quality Standards in a FDA -regulated facility are mandatory. In addition, this individual will also be ... Facility Assets (utilities, equipment, and systems) functionality, reliability, and compliance . + Operate/ Utilize the Computerized Maintenance Management System… more
- CSL Plasma (Winston Salem, NC)
- …+ In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. + Evaluates vein ... (SOPs). You will report to the Assistant Center Manager **The Role** + In compliance with SOPs perform all aspects of the pheresis procedure and plasma collection,… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and improves procedures and Preventative Maintenance Activities. a. Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing ... related to maintenance and reliability is communicated and/or documented for compliance , history, and reliability. c. Strive towards continuous improvement of… more
- ThermoFisher Scientific (Greenville, NC)
- …(ie new lines/processes) + Implementing standard methodology (ie ensuring understanding / compliance with updated Annex 1 - leading the transition and any risk ... sterile lines) would be beneficial. + Familiarity with US FDA , EU Annex-1 and other regulations and guidance. +...+ Outstanding technical writing skills + Influencing + cGMP Compliance + Strong sense of diplomacy and assertiveness +… more
- Teleflex (Morrisville, NC)
- …to minimize cost of quality throughout the product's lifecycle. * Ensure compliance of all practices to the Quality Management System. Ensure comprehensive ... Understand applicable external regulations and internal standards that drive compliance and apply them in their daily function. Perform...industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820. * Proficient in MS Office, and Minitab… more
- Fujifilm (Raleigh, NC)
- …mapping for project and or post go-live support cases in compliance with the company's quality procedures. **Company Overview** At FUJIFILM Healthcare ... customization, and electronic delivery of technical clinical tools and supplements. + Compliance with respect to all applicable requirements of the company's quality… more
- Catalent Pharma Solutions (Greenville, NC)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. Catalent's ... a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer...entries are accurately documented and compliant with SOPs and FDA cGMP guidelines. + With minimal supervision, conduct setup,… more
- Mentor Technical Group (NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With… more
- Burns & McDonnell (Charlotte, NC)
- …effective management of change orders. + Applies knowledge and understanding of FDA , cGMP, and other concepts, practices, codes, and procedures within the industry. ... data as required by the project managers to verify design compliance with project, client, and industry standards, including constructability. + Quality… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... of UT databases, abstracts, manuscripts, and posters, ensuring scientific validity and compliance with regulatory standards + Collaborate with HEOR to support and… more