- 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:** + Bachelor's degree in biomedical… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …of 10 years relevant experience - Experience in dealing with the FDA regarding license submissions, inspections and audit follow-up required - Aeseptic/sterile ... filling experience preferred *Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level… 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 offices in Caguas, Puerto Rico, and Boston and we serve life sciences clients in six global… 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 offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… 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 offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more
- Charles River Laboratories (Raleigh, NC)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices. In addition, personnel in this position ... will employ above average mechanical aptitude and acceptable aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Personnel in this position will provide support in inspection and packaging… more
- Catalent Pharma Solutions (Greenville, NC)
- …and logbook entries are accurately documented and compliant with SOPs and FDA cGMP guidelines. + With minimal supervision, conduct setup, changeover, and ... manufacturing activities with adherence to SOPs and safety requirements. + Other duties as assigned. **The Candidate** + High school diploma or equivalent with at least 2 years of experience in pharmaceutical OSD manufacturing or + Associate degree with at… more
- ThermoFisher Scientific (High Point, NC)
- …Life: + Follow quality standards in accordance with company policy, cGMP and FDA requirements. + Assist in the installation and maintenance of utilities systems and ... equipment components for electrical power distribution, instrumentation and controls, electrical machinery, responsible for knowledge of codes and standards. + Perform preventive and predictive maintenance. + Performs alternating or rotating shift work as well… more
- North Carolina State University (Raleigh, NC)
- …study administrative duties and budgetary activities. Required Qualifications: + Experience working on FDA regulated trials + Ability to work with a high degree of ... independence and initiative. + Experience with Microsoft Office, Teams, and REDCap. + Ability to pay attention in detail. Preferred Qualifications: + Master's degree or higher in health services research, exercise and sports science, public health,… more