- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** Act as the primary… more
- ManpowerGroup (Milton, PA)
- …or processing industry. + Strong knowledge of sanitation chemicals, methods, and regulatory requirements ( FDA , USDA, GMP, SSOP, HACCP). + Experience managing ... and facility areas are cleaned and sanitized according to FDA , USDA, and company standards. + Develop and execute...period consultants are eligible for:** + Medical and Prescription Drug Plans + Dental Plan + Vision Plan +… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Biomat USA, Inc. (Fairless Hills, PA)
- …and compliance with all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety ... activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA requirements and ACR recommendation as well as local state regulations for… more
- Pfizer (Collegeville, PA)
- …clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong ... external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision… more
- Advatix, Inc. (Breinigsville, PA)
- …assigned Distribution Center. This position serves as an interface for the Food and Drug Administration ( FDA ) and ISO and other state, and local regulatory ... Quality Assurance and Regulatory Compliance Associate Role Summary The QARC Associate...Programs, systems for clients, and software meet all applicable regulatory requirements and are consistent with internal QA goals… more
- Sanofi Group (Swiftwater, PA)
- …sponsor/monitor inspectorate activities. As such, they may interact with representatives of Regulatory Agencies ( FDA , MHRA, PMDA, NMPA, ANSM, EMA, etc.). ... ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could… more
- Penn Medicine (Philadelphia, PA)
- …(The Joint Commission), OSHA (Occupational Safety and health Act), NRC (Nuclear Regulatory Commission), DEA ( Drug Enforcement Agency), DOT (Dept. of ... teaching functions with residents/fellows, Medical Laboratory Science and other students. Regulatory Compliance: Works with the Division's Quality Assurance manager… more
- Penn Medicine (Philadelphia, PA)
- …(The Joint Commission), OSHA (Occupational Safety and Health Act), NRC (Nuclear Regulatory Commission), DEA ( Drug Enforcement Agency), DOT (Dept. of ... the Division's Quality Assurance manager in functioning as liaison to accrediting/ regulatory agencies in preparation for inspections, site visits, documentation of… more