- 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 offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six… more
- Charles River Laboratories (Raleigh, NC)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Alaka'ina Foundation Family of Companies (Camp Lejeune, NC)
- …policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonization (ICH) ... regulations and IND/IDE requirements. + Knowledge of medical terminology and treatment concepts. + A comprehensive, intensive, practical knowledge of the entire clinical research program that includes: protocol preparation, processing for approval, and… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …APP will also provide oversight for administration of both investigational and FDA -approved enzyme replacement therapy infusions for patients with lysosomal storage ... Employment Type: Permanent Faculty Vacancy ID: FAC0005542 Salary Range: Dependent on Experience and Qualifications Position Summary/Description: The Division of Genetics and Metabolism in the Department of Pediatrics at the University of North Carolina is… more
- ThermoFisher Scientific (Greenville, NC)
- …be considered! **Knowledge, Skills, Abilities:** Knowledge in GMP's and FDA regulations. Technical writing experience, preferred. Technical and operational knowledge ... of start-up of aseptic environment for live virus vaccines. Strong decision-making skills. The ability to handle multiple ongoing activities and ability to prioritize tasks. Outstanding attention to detail and organizational skills. Capable of flourishing in a… more
- Burns & McDonnell (Charlotte, NC)
- …effective management of change orders. + Applies knowledge and understanding of FDA , cGMP, and other concepts, practices, codes, and procedures within the industry. ... + Demonstrated ability to develop designs in new or renovated facilities which integrate equipment, processes, and people. + Experienced in developing Process Architect deliverables across the Life Sciences industry including but not limited to Animal Health,… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** + BA/BS or equivalent, with 5+ years of… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications** Experience: + Minimum five (5) years previous service-related experience. + Demonstrated ability at operating installation tools and test equipment. + Extensive knowledge and experience in… more
- Catalent Pharma Solutions (Greenville, NC)
- …and logbook entries are accurately documented and compliant with SOPs and FDA cGMP guidelines. + Assist with setup, manufacturing, and changeovers with adherence ... to SOPs and safety requirements. + All other duties as assigned. **The Candidate** + High school diploma or equivalentwith at least 1 year of manufacturing or related experience or completion of Grads2Work Program or BioWorks certificate program required. +… more
- CSL Plasma (Wilmington, NC)
- …donor disconnect. + In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. + Evaluates ... vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the… more