- Kedplasma (Burlington, NC)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...needed. + Records any required documentation accurately and in compliance with company SOPs. + Maintains data integrity and… more
- Merck (Raleigh, NC)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for this position ... aimed at answering customer and industry questions, monitoring protocol compliance , and summarizing results from post-approval marketing support trials specific… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …controlled documents in accordance with company policies and regulatory agency (eg, FDA and ISO) requirements. + Provide assistance with the review and revision ... well-organized, clean and tidy manner at all times in compliance with cGMP requirements. + Demonstrate and work towards...of a team with minimal supervision. + Knowledge of FDA and/or GMP regulations preferred. + Prior ERP experience… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... staff during assigned shifts. + Learns and maintains thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration… more
- American Red Cross (NC)
- …+ Demonstrated ability to lead strategic growth, manage multidisciplinary teams, and maintain compliance with FACT, CLIA, and FDA standards. Develop new theories ... stem cell collection/processing, CAR-T support, and emerging therapies.** **Laboratory Compliance ** **- Oversee medical and regulatory standards for Cell Therapy… more
- Mentor Technical Group (Monroe, NC)
- …manufacturing operations activities. + Is responsible for overseeing work order activity compliance with respective regulatory requirements (ie FDA , DEA, OSHA). ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Astellas Pharma (Sanford, NC)
- …responsibility for reviewing and identifying opportunities to proactively assure compliance to all applicable internal, domestic, and international quality ... GxP documentation/records. + Participate and represent the company in regulatory (eg, FDA , EMA, DHHS, etc.) inspections and audit activities conducted by third-party… more
- Reckitt (Wilson, NC)
- …with QC/Supply + Responsible for all R&D technical activities in the compliance programme under your remit, working closely with the technical project manager ... Ensure all activities comply with relevant regulatory standards (eg FDA , cGMP) + Can be counted on to consistently...(GDP) and Good Manufacturing Practices (GMP), as well as FDA and ICH guidelines + Proficient in Microsoft Project,… more
- Biomat USA, Inc. (Kannapolis, NC)
- …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...standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and… more
- Medtronic (Charlotte, NC)
- …as assigned/requested by management + All activities must be performed in compliance with the Quality System + Travel requirement (international possible): 20-40% ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more