- WCG Clinical (Cary, NC)
- …services companies. We deliver transformational solutions that stimulate growth, foster compliance , and maximize efficiency for those performing clinical trials. WCG ... data by developing and validating SAS programs that meet regulatory standards. This position involves leading programming activities and...+ At least 3 years of experience in the pharmaceutical , vaccines, biotech, or medical device industry + In… more
- ThermoFisher Scientific (Greenville, NC)
- …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
- UNC Health Care (Rocky Mount, 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
- BlueCross BlueShield of North Carolina (NC)
- …savings quarterly to Corporate Pharmacy and other leadership teams. + Ensure clinical compliance with law and regulatory bodies, including the Centers for ... D, Medication Therapy Management, Nursing Practice, Patient Care Coordination, Pharmaceutical Medical Affairs, Pharmacy, Pharmacy Compliance , Pharmacy… more
- Lilly (Concord, NC)
- …of cGMP practices including good documentation practices, data integrity and regulatory compliance + Demonstrated ability to communicate with cross-functional ... in the assigned manufacturing area. . Follow good documentation practices and compliance with site procedures. . Review and approve GMP documentation such as… more
- Merck (Durham, NC)
- …responsible for aligning maintenance projects with the business objectives around Safety, Compliance and Cost. The Senior Mechanical Services Engineer must be able ... cGMP requirements. + Support safety programs (LOTO, HECP, etc.) and environmental compliance from a maintenance perspective + Collaborates with the production area… more
- Lilly (Durham, NC)
- …maintenance) to achieve site goals while providing Quality oversight and ensure compliance . **Responsibilities** : + Responsible for adhering to safety rules and ... shifts. + Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel. +… more
- Lilly (Concord, NC)
- …LES, and MODA. **Additional Preferences:** + Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility. + Strong ... and utility sampling. **Key Objectives/Deliverables:** + Adhere to and promote compliance with all cGMP procedures, Quality Systems, and Good Documentation… more
- Lilly (Durham, NC)
- …to achieve site goals while providing Quality oversight and ensuring compliance . **Key Objectives/Deliverables** : + Responsible for adhering to safety rules ... site goals. + Responsible for ensuring training is completed and remains in compliance . Communicates with Quality Specialist Lead and QA Floor Support Supervisor on… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …maintain product inventory for active stability studies in accordance with all compliance requirements by assuring the accountability and delivery of all stability ... audit all sample labeling and documentation for accuracy and compliance with GMP. + Facilitate delivery of stability samples...of ICH guidelines and GMP requirements set forth by regulatory agencies associated with the storage of Stability product… more