- Roche (Carlsbad, CA)
- …best-in-class expertise + Serving as subject matter expert with the US FDA , Notified Bodies, international regulatory agencies and other regulatory bodies to advance ... ways of working with a focus on delivering high quality submissions + You enable the organization's New Ways...in IVD, Pharmaceutical, and /or Medical Device industry; Regulatory Compliance , Federal cGMP's and QSR's, ISO13485 and 27001. +… more
- Bayer (Denver, CO)
- …meetings including program evaluation, required attendance and coordination of high quality meeting reports; + Identifies educational gaps and provides subsequent ... Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and… more
- Actalent (Altamonte Springs, FL)
- …staff. + Advocate for patient safety and rights, ensuring informed consent and compliance with FDA and ICH/GCP guidelines. + Maintain clinical competencies, ... assigned research projects and ensuring adherence to study-specific protocol guidelines, FDA regulations, and ICH/GCP guidelines. The role demands patient advocacy… more
- Actalent (Mount Prospect, IL)
- …chemistry techniques, such as titration. + Strong understanding of GMP, GDP, and FDA compliance . + Excellent documentation skills with attention to data ... methods such as titrations, pH, specific gravity, and HPLC within the Quality Control (QC) department. Responsibilities + Conduct daily testing using HPLC, GC,… more
- Battelle Memorial Institute (West Jefferson, OH)
- …and government clients increases the speed of the development while maintaining quality and compliance . The Toxicologist functions as a study director ... setups. + Participates in all required training. + Follows FDA GLP and other appropriate regulatory (eg, OECD, ICH)...in random drug screening. Willing to be immunized with FDA licensed vaccines and Investigational New Drugs (IND) recommended… more
- Abbott (San Diego, CA)
- …identified, obtained, and effectively presented for product registration worldwide (US, FDA , CE-IVDR, PMDA, etc.). **Strategic Planning:** + Identify and approve new ... guidance on regulatory requirements to development teams. + Manage preapproval compliance activities. + Formulate company procedures to respond to regulatory… more
- Biomat USA, Inc. (Dallas, TX)
- …employees and supervise donor flow. + Learn and maintain thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration ... ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health...with other service areas to ensure accurate documentation and quality . + Builds rapport with donors to ensure overall… more
- Belcan (City Of Industry, CA)
- …rejected or relocated from the inspection line * Responsible for maintaining CGMP compliance by insuring a high level of cleanliness and organization. * Complies ... School Diploma/GED * 1+ year experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is desirable. * Experience working with cGMPs and Industry… more
- SSM Health (St. Louis, MO)
- …samples. + Maintains manufacturing records and completes all required documentation in compliance with Current Good Manufacturing practices (cGMP), FDA , US ... rooms and ISO 5 workspaces. Ensures admixtures are completed properly per FDA and Current Good Manufacturing practices (cGMP) requirements. Responsible for managing… more
- Sysco (Auburndale, FL)
- …industry standard safety policies and procedures - OSHA, NEC, NFPA, USDA, FDA , etc. + Perform inspections and complete preventive/predictive maintenance tasks on ... production and process utility equipment to increase quality , safety, and overall equipment reliability. + Diagnose and repair production and process utility… more