- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for ... programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation;… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …challenges. Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer ... provides customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent...reviewed as it pertains to cGMPs, site SOPs, and FDA /MCA regulatory guidelines). + Provide support to internal, client,… more
- Fujifilm (Holly Springs, NC)
- … systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in ... resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards + Provides comprehensive QA oversight… more
- Endo International (Rochester, MI)
- …Chain to meet plant objectives. In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) ... work to bring the best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team and enable us to… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …and/or dietary supplements/ingredients. **Industry Experience:** + Proven experience in establishing quality systems compliance within the above fields. + ... + Regulatory CMC submission experience and/or industry experience in the establishment of quality systems compliance is desirable. + Knowledge of and experience… more
- Bayer (Oklahoma City, OK)
- …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
- BPC Plasma, Inc. (White Settlement, 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
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- Position SummaryPerform work in compliance with all cGMP, ISO, and FDA regulations in addition to company policy and safety guidelines. Responsible for the ... Check incoming deliveries to make sure all ordered material meets quality standards.2. Receive, quantify, and store incoming material with warehouse equipment… more
- 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
- 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