- ThermoFisher Scientific (Wilmington, NC)
- … regulatory requirements, and therapeutic area knowledge. + Ensures compliance with quality processes and requirements for assigned documents. Provides input ... job (comparable to 5+ years). Experience working in the pharmaceutical /CRO industry preferred. Experience working within FSPs preferable. Additional qualifications… more
- Lilly (Lebanon, IN)
- …environment. + Enforce a high standard of housekeeping, safety and environmental compliance in all warehouse areas in accordance with procedures. + Provides coaching ... materials to meet manufacturing production schedules. + Adhere to regulatory agency guidelines while working in the warehouse. +...or equivalent + 3 to 5 years' experience in Pharmaceutical / GMP environments. + Ability to read, write and… more
- UNC Health Care (Hillsborough, NC)
- …job-specific functions. 8. Contributes to process improvement projects. 9. Completes regulatory compliance inspection of medication storage areas, including ... area and returns unused medications to the pharmacy. 3. Documents pharmaceutical activities including patient billing for medications and equipment, quality control… more
- ThermoFisher Scientific (Alachua, FL)
- …the Global Medical Indication Lead + Interpret the clinical trial data for regulatory documents (eg CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and ... staff at Investigator meetings; CRA training in new indications + Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and… more
- Lilly (Indianapolis, IN)
- …GMP utilities, steam, water, sewer, and other utility systems to a state of compliance . They must assure that facilities and related infrastructure are fit for use ... our HVAC/Utilities programs up to date with industry standards, external/internal regulatory documents, and regulatory agencies expectations. Example of these… more
- Abeona (Cleveland, OH)
- …Enterprise Quality Management System (EQMS), to support Good Manufacturing Practices (GMP) compliance at the Abeona Therapeutics Inc. site in Cleveland, OH. This ... Change Control records in the eQMS. + Ensure investigations and CAPAs meet regulatory expectations (eg, FDA, EMA) and are completed within required timelines. +… more
- AbbVie (Florham Park, NJ)
- …Access, and Regulatory Affairs departments concerning a broad range of legal, regulatory , and compliance issues. + Provide clear advice to business clients ... Include: + Serve as the strategic and legal lead counsel for pharmaceutical brands and provide in-depth substantive advice to the Marketing, Medical Affairs,… more
- Lilly (Indianapolis, IN)
- …(PQA), focusing on evaluating HSE capabilities to ensure alignment with HSE regulatory requirements and Lilly HSE expectations. + Leads the HSE screening process ... assessments to validate the partner's ability to meet safety and compliance requirements. + Collaborates cross-functionally with internal LRL partners including… more
- Rockefeller University (New York, NY)
- …to NYSBP, TJC, NYDOH, DEA, FDA, NIH, and all other applicable regulatory agency requirements. Responsibilities Position responsibilities include, but are not limited ... + Dispense medications by compounding, dispensing, packaging, and labeling pharmaceutical products; + Control medications by monitoring drug therapies; advises… more
- West Pharmaceutical Services (Williamsport, PA)
- …Champion a culture of health and safety in accordance with the highest standards of regulatory compliance . + End to end ownership for the full business value ... drawings, specifications, safety rules, operating instructions, procedure manuals and regulatory documentation. + Ability to write routine reports, correspondence… more