- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... and systems + Ensure that the procurement operations function operates in full compliance with health, safety, and regulatory requirements + Ensure that all requests… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …expectations, and quality standards. Primary Duties + Perform all work in compliance with company policy and within the guidelines of bioMerieux's Quality System. ... Adhere to Regulatory requirements, including FDA , ISO, Legal, Ethical, and bioMerieux-specific procedures. + Source a variety of materials, equipment, and services… more
- US Tech Solutions (Wilson, NC)
- …all departments in respect of document control to ensure business, quality and compliance goals are met + Partners with other Departments to ensure that ... and assign privileges as directed by the QA Systems Manager + Set up review and approval routings for...Perform related duties as assigned by supervisor + Maintain compliance with all company policies and procedures **Experience:** +… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary… more
- Biomat USA, Inc. (Kannapolis, NC)
- …employees and supervise donor flow. * Learn and maintain thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration ... ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health...is performed. * Under the guidance of the Center Manager and/or the Assistant Manager , assure facility… more
- Kedplasma (Burlington, NC)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... and screening donors under the direction of the Center Manager . Operates within the scope of EU Guidance on...scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager . Primary responsibilities for this position will be: perform QC analysis in ... compliance to cGMP in line with standards prescribed by...to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of… more
- United Therapeutics (Research Triangle Park, NC)
- …automation, orchestration, and scale + Knowledge of specific pharmaceutical and medical industry compliance regimes and controls a plus (ie FDA 21CFR 11, ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
- ThermoFisher Scientific (Greenville, NC)
- …Position will support to the Greenville, NC, site and will report to the Sr Manager , Validation. The Drug Product Division - North America (DPD-NA) is one of the ... an Engineer III, Validation, you will provide direct quality support through compliance , regulatory assessment, and validation activities. You will lead and guide… more
- Medtronic (Charlotte, NC)
- …as assigned/requested by management + All activities must be performed in compliance with the Quality System + Travel requirement (international possible): 20-40% ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more