- Kelly Services (Clayton, NC)
- …position oversees quality systems, documentation, laboratory operations, regulatory compliance , employee development, staffing, training, and budget. **Primary ... systems + Documentation and data integrity + Laboratory operations + Regulatory compliance (GMP/GxP) + Budget planning and oversight + Employee relations and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …for managing all aspects (ie quality systems, documentation, laboratory operations, compliance , training, staffing and budgetary needs, etc.) of the Quality Control ... Control business unit (quality systems, documentation, laboratory operations, overall compliance , oversee department budget, employee relations,etc.). + Follows cGMP… more
- Mentor Technical Group (NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With… more
- Alaka'ina Foundation Family of Companies (Camp Lejeune, NC)
- …is evaluated by observation and outcomes for effectiveness of operations and compliance with medical requirements and professional standards in terms of quality and ... sponsors, etc. + Review new research protocols for consistency, completeness, and compliance with all DoD, BUMED, NMCCL, and other federal and applicable state… more
- ThermoFisher Scientific (Greenville, NC)
- …priorities. . Ensures production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, ... solutions, and preparing summary reports/recommendations for management. . Assures compliance to all applicable regulations by proactively interpreting regulatory… more
- ThermoFisher Scientific (Greenville, NC)
- …and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead ... ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed.… more
- Veterans Affairs, Veterans Health Administration (Durham, NC)
- …care program that meets current Joint Commission, Food and Drug Administration ( FDA ), College of American Pathologists (CAP), NFPA, and VA requirements, particularly ... codes, regulations, guidelines and standards to make recommendations to assure compliance with healthcare facility programs. (c) Ability to understand the… more
- CSL Plasma (Wilmington, NC)
- …+ In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. + Evaluates vein ... (SOPs). You will report to the Assistant Center Manager **The Role** + In compliance with SOPs perform all aspects of the pheresis procedure and plasma collection,… more
- Evolent (Raleigh, NC)
- …prior authorization and financial scope reconciliations, ensuring accuracy and compliance . + Conduct ongoing surveillance of coding updates from authoritative ... for Medicare & Medicaid Services (CMS), Food and Drug Administration ( FDA ), and various prior authorization lists, facilitating timely decision-making for clinical… more
- BrightSpring Health Services (Charlotte, NC)
- …compounding/clean room areas and related equipment are cleaned, sanitized and maintained in compliance with company policies and procedures, and USP 797 and USP 800 ... quality improvement activities + Adheres to all accreditation, OSHA, FDA , state, local and federal regulations, and USP 797...all sterility testing done in the clean room in compliance with company policies and procedures, and USP 797… more