- BioFire Diagnostics, LLC. (Durham, NC)
- …procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations + Provide assistance with the review and revision of ... OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + Ability… more
- West Pharmaceutical Services (Kinston, NC)
- …manufacturing experience preferred + Experience working with ISO standards, FDA and cGMP required + Pharmaceutical manufacturing experience preferred + ... drawings, specifications, safety rules, operating instructions, procedure manuals and regulatory documentation. + Ability to write routine reports, correspondence… more
- Fujifilm (Holly Springs, NC)
- …efficiency * Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections * Works 12-hour shift on 2-2-3 ... in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. **Preferred Requirements:** * Working knowledge and experience… more
- Kedplasma (Burlington, NC)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... and alerts management of donor flow issues. + Follows all SOPs and regulatory policies and procedures, including the employee handbook. + Responsible for remaining… more
- ThermoFisher Scientific (Greenville, NC)
- …(QA) department. The role focuses on driving and tracking activities related to regulatory requirements, particularly 21 CFR Part 11 and EU Annex 11, within ... systems. This position is essential for maintaining a culture of compliance with FDA , EMA, and other global health authority expectations related to GMP, GDP, and… more
- ITW (Washington, NC)
- …This position reports to ITW Medical's Director, Quality Assurance & Regulatory and is responsible for Quality Assurance activities associated with the ... to identify effective solutions for scrap reduction. Compliance/Certification + Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including… more
- BioLife Plasma Services (Raleigh, NC)
- …and build your skills by contributing to financial, marketing, administrative, regulatory , quality, people, and facilities management. + **Contribute to Creating ... QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment **We Offer Comprehensive… more
- Cordis (Raleigh, NC)
- …information request about off-label products or indications + Collaborate with regulatory and compliance teams to ensure all scientific/marketing materials adhere to ... relevant regulations and standards (eg, FDA , CA, PMDA,Sunshine Act) + Responsible for identifying clinical insights and knowledge gaps and be able to articulate the… more
- HCA Healthcare (Asheville, NC)
- …efficient and effective department operation while maintaining compliance with all ACR, MQSA/ FDA and State of North Carolina within quality and regulatory ... guidelines. Observes strict confidentiality and follows all HIPAA laws in dealing with patients, families, and co-workers. **What qualifications you will need:** + Required Education: Graduate from an accredited Radiological program, Bachelor Degree in related… more
- Teleflex (Morrisville, NC)
- …implemented or existing systems and processes according to quality, compliance, and regulatory requirements * Identify and address technical or operational risks and ... working understanding of technology across many disciplines + Working knowledge of SOX and FDA 21 CFR Part 820 requirements + Firm understanding of IT best practices… more