- Unither Pharmaceuticals (Rochester, NY)
- …maintained from a functional efficiency standpoint and in compliance with the FDA requirements to have and use a formalized equipment maintenance system. ... techniques. *Solid fundamental understanding of mechanical systems and principles. *Knowledge of FDA , CGMP, NFPA, ADA, OSHA, and New York State and local… more
- University of Utah (Salt Lake City, UT)
- …+ Oversees and assists in preparing regulatory documents for submission to the FDA and other regulatory agencies. + Assists in all activities of the radiochemistry ... in development of novel radiopharmaceuticals including validation of non- FDA -approved PET radiopharmaceuticals. + Proven presentation, planning and organization… more
- Specialty Rx, Inc. (Roanoke, VA)
- …requires a strong understanding of CGMP (Current Good Manufacturing Practices) and FDA regulations, as well as mechanical knowledge to operate and maintain packaging ... and organized work area in accordance with safety regulations. + Follow all FDA regulations and company policies related to product handling and packaging processes.… more
- Dartmouth Health (Lebanon, NH)
- …hospital and clinic patient care areas. * Accurately deciphers and implements FDA mandated manufacturer Instructions for Use (IFU). * Determines each medical device ... Maintains all corresponding medical records for traceability per AAMI, FDA , CDC and Hospital requirements. * Performs all QA...including, but not limited to: AAMI, IAHCSMM, AORN, SGNA, FDA , EPA, OSHA, and CMS. * Maintains process for… more
- Stanford University (Stanford, CA)
- …for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to ... the FDA as required. + Audit operations, including laboratory procedures,...and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical… more
- Alaka'ina Foundation Family of Companies (Silver Spring, MD)
- …+ Gather, prepare, and maintain appropriate information and documentation per applicable FDA regulations and ICH guidelines (eg, source and case report forms, ... collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally-required guidances. + Able to design and… more
- J&J Family of Companies (Danvers, MA)
- …calibration traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part 820). **Equipment Selection & Acquisition** + Partner ... compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part 820). **Qualifications / Requirements:**...or manager-level role + Familiarity with ISO 13485 and FDA QSR/21 CFR Part 820; experience with calibration standards… more
- ThermoFisher Scientific (Lenexa, KS)
- …and optimize lab operations. The supervisor will ensure compliance with FDA regulations, Good Manufacturing Practices, and other relevant guidelines. Key ... Ensure all duties are performed in accordance with Standard Operating Procedures, FDA regulations, and Good Manufacturing Practices. + Lead QC team, including… more
- BPC Plasma, Inc. (Brookings, SD)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA),… more
- LiDestri (Fairport, NY)
- …is adequate and meets requirements + Support the submission of processes to the FDA via website + Hands on preparation and communication for Heat Penetration trails ... regulatory process filing files for regulatory compliance; Filing with FDA and California as needed + Report food safety...School Certificate and HACCP certified preferred + Familiar with FDA and USDA regulations + 3 to 5 years… more
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