- Medtronic (Charlotte, NC)
- …in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or ... understand schematics and engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Reckitt (Wilson, NC)
- …a talented team of Process Engineers and Process Technologists, the Technical Manager ensures the efficient, safe, and high-quality manufacturing of liquid and oral ... business imperatives forward. Collaboration is key, and the Technical Manager works cross-functionally to uncover opportunities, deliver impactful improvements, and… more
- Reynolds American (Winston Salem, NC)
- …countries with over 55,000 employees. The GGP prepares you for a Lead Manager role within one year, with international career opportunities across BAT's footprint. ... experience working in a laboratory setting. + Knowledge of FDA regulation processes or experience in another FDA... FDA regulation processes or experience in another FDA -related industry. + Open to relocate globally. + High… 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 ... + Demonstrated knowledge of regulatory/compliance requirements, including anti-kickback laws, FDA promotional regulations, Sunshine Act; and demonstrated knowledge of… 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 ... holidays) on a rotational basis + Participation in Change Manager Role on a rotational basis + Excellent written...medical industry compliance regimes and controls a plus (ie FDA 21CFR 11, HIPAA/HITECH) + Present ideas and information… 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 ... and systems. + Host and coordinate regulatory inspections performed by the FDA , MCA, and other regulatory agencies. + Defend policies, procedures, rationales, and… more
- Cambrex High Point (Durham, NC)
- …workflows for drug substance and drug product. Reporting to the ( Manager , Associate Director, or Director), the Analytical Services Supervisor will provide ... and (where required) development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity, and impurities by… 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 ... Critical Investigations to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct. +… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …** ** **Summary:** Under the direct supervision of the Quality Systems Manager , perform quality assurance and Training functions to ensure compliance with internal ... documentation review for unsuitable test results. * Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are… more
- Kedplasma (Greenville, NC)
- …of the donor during the plasmapheresis process under the direction of Center Manager . Operates within the scope of EU Guidance on Good Manufacturing Practice and ... FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...and meeting(s) in a timely manner as instructed by supervisor/ manager . + Cooperate with department personnel, as well as… more