- 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
- Reckitt (Wilson, NC)
- …SCADA, DCS) for manufacturing / utility operations. + Serve as automation SME and ensure compliance with GxP, FDA , EU Annex 11, and 21 CFR Part 11 requirements. ... design using AutoCAD Electrical or EPLAN. + Experienced in regulatory compliance : GMP, FDA , ISO 9001/13485, EHS, electrical codes, and safety standards. + Strong… 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
- J&J Family of Companies (Wilson, NC)
- …1-year experience in Computer System Validation in a cGMP pharmaceutical facility in compliance with FDA regulations. + Knowledge of Automation Control Systems, ... at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle… 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