- IQVIA (Durham, NC)
- …**CONNAISSANCES, COMPETENCES ET APTITUDES REQUISES :** + Connaissance des directives de la FDA (Food and Drug Administration) et de leur impact sur les operations + ... facilitate escalation management. **RESPONSIBILITIES:** + Ensure consistent and outstanding quality against department deliverables. + Manage customer relationships and… more
- Kelly Services (Winston Salem, NC)
- …regulatory compliance support-including change controls and deviations-while contributing to high- quality regulatory documentation for US and global filings. The ... support regulatory filings. + Ensure that all documentation aligns with regulatory standards ( FDA , EMA, ICH) and internal SOPs. + Assist in preparing responses to… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …working a 2-2-3 rotation schedule. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry ... Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC. + Quality + Ensures all testing documentation is completed in...Experience participating in the management of regulatory audits (ie FDA , MDSAP, ISO, OSHA, EPA, etc.). + Experience in… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and manufacturing operations. This position ensures compliance with cGMP, ISO, FDA regulations, company policies, and safety guidelines while overseeing the physical ... + Receives, verifies, and inspects incoming deliveries to confirm material quality and accuracy. + Quantifies, stores, and organizes materials using warehouse… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices. In addition, personnel in this position ... maintain good attendance. - Responsible for maintaining the company-s high standards of quality , to meet the day-to-day scheduling needs and have the ability to… more
- Cardinal Health (Raleigh, NC)
- …to update manufacturer knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct secondary research (eg, ... manufacturers and products. + **Executive presentations:** Consolidate information into high- quality presentations or memos with meticulous attention to detail.… more
- 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
- Reckitt (Wilson, NC)
- …by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege. **Supply** Our supply ... relationships. Our Manufacturing Excellence team help us improve the efficiency, quality and safety of our manufacturing operations, and our Logistics Excellence… more
- Lilly (Concord, NC)
- …safety projects. + Follow all GMP, and other regulatory requirements. Participate in quality initiatives and audits. Provides leadership for compliance to FDA , ... Strong interpersonal and communication skills + Solid understanding of quality and corporate policies + Solid understanding of the...and basic requirements of regulatory agencies such as the FDA , OSHA, and EPA + Demonstrate solid judgement and… more
- Mentor Technical Group (Monroe, 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 ... overseeing work order activity compliance with respective regulatory requirements (ie FDA , DEA, OSHA). + Manage Work through the Computerized Maintenance Management… more