- Novo Nordisk (Clayton, NC)
- …batch reports, SOPs, etc. required + Demonstrated knowledge of requirements/expectations of regulatory authorities eg FDA required + Experience with IT systems, ... system to support production plans. Meet or exceed customer, business & regulatory requirements in accordance with Novo Nordisk Way. Relationships Reports to Senior… more
- ThermoFisher Scientific (Greenville, NC)
- …relevant standards. + Ensure all processes and documentation are up-to-date and ready for regulatory inspections (eg, FDA , EMA). + Act as a subject matter expert ... communication, leadership, and interpersonal skills. + Knowledge of quality systems, regulatory compliance (eg, cGMP), and audit preparation. + Ability to work… more
- Cytel (Raleigh, NC)
- …with a strong foundation in statistics. + Demonstrated experience interacting with regulatory agencies (eg, FDA , EMA) and contributing to health authority ... machine learning), with experience across all phases of development and global regulatory interactions. We are seeking an **Executive Consultant** - a seasoned… more
- US Foods (Lexington, NC)
- …safety, quality, and preventative maintenance. * Support the FSQA Manager to Ensure regulatory compliance with USDA, FDA , State and local authorities and act ... safety and raw material compliance specifications * Manage labeling compliance with USDA/ FDA regulations * Ensure complete data collection and trending on relevant… more
- Actalent (Wilson, NC)
- …PM, and QMS frameworks. + Ensure electrical documentation adheres to GDP standards and regulatory compliance (eg, FDA , NEC, NFPA, OSHA). + Develop and manage ... project budgets, cash flow forecasts, and detailed implementation schedules for electrical scope. + Lead or mentor junior engineers and technicians in electrical project execution and troubleshooting. + Generate and manage electrical engineering documentation… more
- Oracle (Raleigh, NC)
- …**Oracle Cloud SCM, Manufacturing, Quality, and ERP** integrations. + Knowledge of ** regulatory compliance processes** ( FDA , ISO, cGMP) and quality documentation ... management. + Familiarity with **Oracle Visual Builder Studio** , **BI Publisher** , and **Reports** for PLM analytics. + Certification in **Oracle Cloud PLM or PDH** modules. + Strong understanding of **product data governance frameworks** and enterprise data… more
- Reckitt (Wilson, NC)
- …into SOP and PM frameworks. + Ensure documentation complies with GDP standards and regulatory requirements (eg, FDA , OSHA, ISO). + Assist in preparing project ... schedules, progress reports, and documentation such as layout drawings, URS, and traffic flow maps. + Participate in project meetings to communicate progress and identify risks. + Monitor contractors and installation teams under supervision to ensure… more
- Novant Health (Winston Salem, NC)
- …independently while following department/program policies and procedures, as well as regulatory requirements (ex. FDA , FACT). + Administers pre-transplant ... conditioning chemotherapy regimens and pre-CAR T lympho-depleting chemotherapy. + Performs hematopoietic cell transplantation and cellular product infusions. + Maintains and cares for patient venous access used during apheresis procedure. + Monitors patients… more
- Reckitt (Wilson, NC)
- …PM, and QMS frameworks. + Ensure electrical documentation adheres to GDP standards and regulatory compliance (eg, FDA , NEC, NFPA, OSHA). + Develop and manage ... project budgets, cash flow forecasts, and detailed implementation schedules for electrical scope. + Lead or mentor junior engineers and technicians in electrical project execution and troubleshooting. + Generate and manage electrical engineering documentation… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Knowledge and Skills : Strong understanding of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as ... timely manner. This position will also provide site representation for regulatory surveillance program. JOB RESPONSIBILITIES: Financial: Provide support in resource… more