- 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** + Bachelor's degree in computer science, Information Systems, Electrical/Mechanical Engineering, or other related field with a minimum of 8 years technical support related experience or… more
- Cook Medical (Winston Salem, NC)
- …CO-OPs* Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements* Must maintain ... all training requirements for the position, while seeking out opportunities for continuous development and growth Qualifications * College/University student entering Sophomore, Junior or Senior year the following Fall Semester or Graduate student enrolled in… more
- Amgen (Holly Springs, NC)
- …and International Conference on Harmonization (ICH) / Food & Drug Administration ( FDA ) mentorship documents related to analytical method transfer and validation. + ... Effective oral and verbal communication skills. + Technical writing skills and attention to details in documents. + A self-starter and valuable teammate. **What you can expect of us** As we work to develop treatments that take care of others, we also work to… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Strong understanding of CGMP/GLP and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical ... industry. Must be proactive, results-oriented with a strong attention to detail and strong time management skills. Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment. Ability to… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …or equivalent. + Two years' experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is desirable. + Knowledge of cGMPs and Industry Standards. ... + Ability to follow "Standard Operating Procedures". + Possess good verbal and written communication skills. + Possess basic math skills (addition, subtraction, division, multiplication). + Basic Computer skills. **Occupational Demands** Work is performed in a… more
- Merck (Raleigh, NC)
- …and focus on scientific education and dialogue + A thorough understanding of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant to the ... pharmaceutical industry and its customers to ensure compliance with all external and internal guidelines and standard operating procedures + Ability to organize, prioritize, and work effectively in a constantly changing environment and to motivate a team to do… more
- Parexel (Raleigh, NC)
- …applicable. + Ensure document structure, content, and style adheres to FDA /EMA or other appropriate regulatory guidelines, and comply with departmental, corporate ... or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before… more
- Teleflex (Charlotte, NC)
- …to organizational goals, policies, procedures, good manufacturing practices, and FDA regulations, including strict compliance with applicable policies and ... regulations for both product lines. * Maintain a professional and credible image with key stakeholders, including physicians, consultants, suppliers, and teammates, for both UroLift System and Barrigel Rectal Spacer products. * Establish and maintain necessary… 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
- J&J Family of Companies (Raleigh, NC)
- …in a fast-paced environment while managing multiple priorities. + Must not be debarred by FDA for work in any Medical Device business. + Must have a valid driver's ... license. + Operate as a team and/or independently while demonstrating flexibility to changing requirements. + There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) + Employee may be required to lift objects up… more