- ThermoFisher Scientific (Greenville, NC)
- …Impactful Work:** As an Engineer III, Validation, you will provide direct quality support through compliance , regulatory assessment, and validation activities. ... systems to ensure compliance with new and changing regulations and conduct quality systems training across the company. + Identifying areas of non- compliance … more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA , and internal quality standards. This position is in a fast-paced, ... implement continuous improvement opportunities to optimize workflows in the quality control microbiology laboratory. OVERALL JOB RESPONSIBILITIES: Operational Excellence:… more
- Cambrex High Point (Durham, NC)
- …SOPs, and regulatory guidance documents.* Strong knowledge of safety procedures and quality compliance for assigned area* Strong knowledge of cGMP requirements.* ... manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career...development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity,… more
- IQVIA (Durham, NC)
- …part of the relevant content review teams. In this role and as part of the Medical Quality and Compliance team you will be working alongside and as part of the ... our clients in line with the requirements of the FDA (FDCA) / PhRMA / FTC for pharmaceuticals and...seamless and consistent approach to content approval and consultative compliance advice to the US based clients and business.… 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
- Reckitt (Wilson, NC)
- …this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege. **Research & Development** ... develop and enhance our existing portfolio, never compromising on quality or performance. We do the right thing, always,...+ Responsible for all R&D technical activities in the compliance programme under your remit, working closely with the… 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 ... daily operational plans to achieve center performance targets related to donor throughput, quality , and productivity. + Partners with Center Manager and Quality … more
- Merck (Raleigh, NC)
- …lead the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently ... with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. **Primary… more
- Reckitt (Wilson, NC)
- …Lean, Six Sigma, and Kaizen initiatives to drive continuous improvement in safety, quality , and productivity. + Compliance & Documentation: Ensure all processes ... comply with cGMP, FDA , and Reckitt quality standards. Maintain accurate and complete documentation (batch records, SOPs, deviation reports). + Cross-Functional… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and procedures adequately to confirm conformance and to provide input regarding the quality / compliance of each. + The ability to function in a ... improvement efforts through the use/implementation of documentation innovation and quality related processes; thereby aligning and consolidating procedural documents… more