- Owens & Minor (Morrisville, NC)
- …medical supplies onto delivery vehicle. + Complies with all applicable regulatory requirements including providing documents needed for the driver qualification file ... is performed on a timely basis according to DOT, FDA and Joint Commission. + Responds to emergency delivery...+ Must meet job-related requirements to comply with DOT, FDA and Joint Commissions regulations. **SKILLS, KNOWLEDGE AND ABILITIES**… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA , and internal quality standards. This position is in a fast-paced, ... FDA regulated environment in the Pharmaceutical Industry. This role...SOPs and cGMP. Compliance: + Maintain current knowledge of regulatory and industry standards, trends and advancements. + Responsible… 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 ... works autonomously to enhance efficiency while upholding safety, environmental, and regulatory standards Primary Duties: + Receives, verifies, and inspects incoming… more
- Reckitt (Wilson, NC)
- …that production is executed efficiently, safely, and in compliance with all regulatory , quality, and cGMP standards. The manager is accountable for delivering daily ... actions documented in SPIN. + Maintain full compliance with cGMP, FDA , and internal quality standards, overseeing batch documentation, deviation management, and… more
- Cambrex High Point (Durham, NC)
- …and (where required) development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity, and impurities by ... managing* Good business acumen* Strong understanding of company SOPs, and regulatory guidance documents.* Strong knowledge of safety procedures and quality… more
- Cardinal Health (Raleigh, NC)
- …to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company ... (GPOs, IDNs, hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory /compliance and contract manufacturing. **_Responsibilities_** + Demonstrate strong business… more
- ThermoFisher Scientific (Greenville, NC)
- …and implement systems to achieve process improvements and efficiencies. + Coordinate regulatory inspections performed by the FDA , MCA, and other agencies. ... with clients on agreements and resolving significant validation, product, and regulatory issues. + Prepare, review, and approve production, validation, and audit… more
- United Therapeutics (Morrisville, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... studies, training and supporting technologists, maintaining QC/QA documentation and regulatory readiness, and contributing to our robust research and development… more
- ThermoFisher Scientific (Wilmington, NC)
- …trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring. As part of your work with ... trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor… more
- Lilly (Concord, NC)
- …At least 2 years working within manufacturing/operations. + Understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA, or ... Environmental (HSE) functional groups + Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related… more