- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …data for evaluation and execution of stability study as per Quality and regulatory requirement. Timely complete testing and ensure compliance during analytical ... and Critical Investigations to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct.… more
- ThermoFisher Scientific (Greenville, NC)
- …As an Engineer III, Validation, you will provide direct quality support through compliance , regulatory assessment, and validation activities. You will lead and ... Greenville, NC, site and will report to the Sr Manager , Validation. The Drug Product Division - North America...shortcomings in processes and systems. + Host and coordinate regulatory inspections performed by the FDA , MCA,… more
- Merck (Durham, NC)
- …Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product activities ... this knowledge in own work + Understands and applies regulatory / compliance requirements relative to their role...a team environment **Preferred:** + Experience with responding to regulatory questions with multiple agencies ( FDA , EMA,… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …the daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations ... of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary… more
- Kedplasma (Hickory, 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
- United Therapeutics (Research Triangle Park, NC)
- …to ensure compliance of new systems with all mandatory legal, regulatory and security policy requirements Minimum Requirements + Associate Degree in computer ... holidays) on a rotational basis + Participation in Change Manager Role on a rotational basis + Excellent written...scale + Knowledge of specific pharmaceutical and medical industry compliance regimes and controls a plus (ie FDA… more
- Medtronic (Charlotte, NC)
- …in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics ... by management + All activities must be performed in compliance with the Quality System + Travel requirement (international...understand schematics and engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable… 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. ... of two primary areas: Scientific Research & Development (SR&D) and Scientific and Regulatory Affairs (S&RA). Within these spaces you could work in various spaces… 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
- Merck (Wilson, NC)
- …and Skills:** * Relevant work experience encompassing a working knowledge of FDA regulatory requirements * cGMP experience in a pharmaceutical manufacturing, ... Process, Manufacturing Scale-Up, Motivating Teams, Pharmaceutical Packaging, Professional Networking, Regulatory Compliance , Social Collaboration, Strategic Thinking, Technical… more