- Actalent (Winston Salem, NC)
- …engineering. + Understanding of full compliance for lab instrumentation, validation protocols, FDA compliance , audit, lab equipment, IQ, OQ, PQ. + Audit and ... provides technical oversight, manages qualification activities, and ensures regulatory compliance and data reliability throughout system lifecycles. Responsibilities +...FDA experience. Additional Skills & Qualifications + Education in… more
- BD (Becton, Dickinson and Company) (Mebane, NC)
- …to engineering drawings. Typically requires oversight from a more senior level engineer + ISO compliance , FDA 21 CFR 820 compliance , and cGMP efforts - ... Understands and has knowledge of FDA and ISO regulations and cGMP. Requires oversight from...regulations and cGMP. Requires oversight from SME to ensure compliance in all applicable areas + Computer Aided Design… more
- ManpowerGroup (Raleigh, NC)
- …on the job and specialized technical training. Strong applied and working knowledge of FDA ; GMP; GLP; compliance and NIST traceability. Expert knowledge of test ... II is expected to have a broader knowledge base of instrumentation and regulatory compliance . They will continue to train on new instrumentation areas and build an… more
- Lilly (Durham, NC)
- …awareness within the organization. ** Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by ... across the internal and external manufacturing network, and drive compliance with regulatory requirements. This role requires in-depth technical knowledge,… more
- UNC Health Care (Hendersonville, NC)
- …the initial and ongoing consent process is performed and documented in compliance with FDA , International Conference on Harmonization Good Clinical Practice ... clinical care for patients enrolled in a clinical trial while adhering to all FDA , OHRP and GCP guidelines and regulations. This position has a central role in… more
- Kelly Services (Wilson, NC)
- …+ Coordinate documentation review, approval, revision, and archival processes to ensure compliance with FDA /EMEA regulations. + Partner with internal teams ... Documentation Specialist, you will play a critical role in ensuring compliance and quality across key documentation systems within a cGMP-regulated environment.… more
- Lilly (Concord, NC)
- …regulatory requirements. Participate in quality initiatives and audits. Provides leadership for compliance to FDA , OSHA, EPA regulations. + Identifies and ... the importance of and basic requirements of regulatory agencies such as the FDA , OSHA, and EPA + Demonstrate solid judgement and initiative + Enthusiastic, positive… more
- Novant Health (Wilmington, NC)
- …resource allocation in dynamic environments. + Expertise in regulatory compliance (ICH/ FDA /OHRP), clinical trial budgeting/contracting, IRB/IBC relations, and ... Health's strategic research initiatives, overseeing clinical trials, and ensuring compliance across hospitals, clinics, and partnerships. This role provides… more
- Honeywell (Charlotte, NC)
- …batch execution and recipe management, quality management systems, regulatory compliance (GMP, FDA , EMA), manufacturing analytics, digital transformation ... challenges including technology transfer, batch execution, quality management, regulatory compliance , and operational efficiency. **Key Responsibilities** Lead and develop… more
- Teleflex (Morrisville, NC)
- …technical content is strongly preferred * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian ... Medical Device Regulations, and all other international regulatory requirements with which Teleflex complies. **Specialized Skills / Other Requirements** * Proficiency in Microsoft (ie PowerPoint (required), familiarity with other presentation tools a plus *… more