- WCG Clinical (Cary, NC)
- …align expectations based on internal capability/capacity and compliance and regulatory requirements. By coordinating service delivery and orchestrating resources ... Current CIP (Certified IRB Professional) certification preferred. + Knowledge of FDA Code of Federal Regulations and ICH Guidelines. **QUALIFICATIONS/EXPERIENCE:** +… more
- Fujifilm (Holly Springs, NC)
- …efficiency + Participates in optimization or improvement initiatives and support regulatory agency and third‐party inspections. + Performs other duties as assigned. ... in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. + Experience in Commissioning, Qualification, and Validation… more
- Grifols Shared Services North America, Inc (Fayetteville, NC)
- …activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a ... all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration… more
- Stryker (Durham, NC)
- …+ Lead and mentor teams to build robust software architecture aligned with regulatory requirements. + Drive development and utilization of tools and systems that ... management. + Knowledge of medical device regulations (eg, US FDA 21 CFR Part 820, ISO 13485, ISO 14971,...820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, FDA cybersecurity guidance). 115,600.00 to 245,800.00 salary plus bonus… more
- System One (Concord, NC)
- …This position ensures trials are executed in accordance with ICH-GCP, FDA , and institutional standards, maintaining participant safety and scientific integrity. The ... the sponsor, CRO, and study staff. Responsibilities + Provide medical and regulatory oversight for dermatology-focused clinical studies. + Review and approve study… more
- Herbalife (Winston Salem, NC)
- …specializing in Document Control diverse backgrounds in quality assurance, regulatory compliance, and manufacturing operations. Their collective experience spans ... AND BACKGROUND REQUIRED TO BE SUCCESSFUL: Strong understanding of GMPs, FDA documentation requirements, and GDP. Proficiency in document management systems and… more
- Owens & Minor (Morrisville, NC)
- …medical supplies onto delivery vehicle. + Complies with all applicable regulatory requirements including providing documents needed for the driver qualification file ... is performed on a timely basis according to DOT, FDA and Joint Commission. + Responds to emergency delivery...+ Must meet job-related requirements to comply with DOT, FDA and Joint Commissions regulations. **SKILLS, KNOWLEDGE AND ABILITIES**… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA , and internal quality standards. This position is in a fast-paced, ... FDA regulated environment in the Pharmaceutical Industry. This role...SOPs and cGMP. Compliance: + Maintain current knowledge of regulatory and industry standards, trends and advancements. + Responsible… 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 ... monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + Monitors the safety and...collection center for audits. + Follows all SOPs and regulatory policies and procedures, including the employee handbook. +… more
- Transylvania Vocational Services (Brevard, NC)
- …+ Regulatory Compliance - Maintain readiness for audits (SQF, FDA , USDA, customer) and ensure documentation, verification, and safety standards are always ... food manufacturing (allergen-sensitive environments a plus). + Strong knowledge of FSMA, USDA, FDA , and GFSI (SQF preferred). + Proven ability to lead and motivate a… more