- Cardinal Health (Deland, FL)
- …patient safety. + Lead, maintain, and continually improve the Quality Management System in compliance with ISO 13485, FDA QSR, and other relevant standards. + ... personnel to achieve site quality goals and maintain regulatory compliance . + Lead actions for regulatory, customer and corporate...supply chain teams to ensure product quality and process compliance . + Train and mentor staff on quality procedures… more
- Grifols Shared Services North America, Inc (Fort Myers, FL)
- …teams of needed updates/changes **Additional responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, & ... abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding...to evaluate complex issues and meet deadlines to ensure compliance , as well as business timelines to accomplish company… more
- Sumitomo Pharma (Tallahassee, FL)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... (written, verbal, electronic, etc.) that an employee encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable… more
- Grifols Shared Services North America, Inc (St. Petersburg, FL)
- …daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary… more
- Biomat USA, Inc. (Orlando, FL)
- …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...is performed. * Under the guidance of the Center Manager and/or the Assistant Manager , assure facility… more
- Biomat USA, Inc. (Kissimmee, FL)
- …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...is performed. * Under the guidance of the Center Manager and/or the Assistant Manager , assure facility… more
- CSL Plasma (Greenacres, FL)
- …facility compliance with CSL procedures and policies, cGMP, OHSA, FDA , and other regulations, as applicable, and develop center responses for deficiencies. ... **The Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall … more
- Kedplasma (Bradenton, FL)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... and screening donors under the direction of the Center Manager . Operates within the scope of EU Guidance on...scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has… more
- JBT Corporation (Lakeland, FL)
- …through thermal process consulting services. You will report to the Senior Manager of Innovation. Provide Process Authority validation and support services for ... aseptic processing and filing technologies globally. Conduct microbiological validations, compliance audits, and optimize processes for various sterilization technologies.… more
- Bausch + Lomb (Tampa, FL)
- …processes associated with the manufacture of pharmaceutical products to assure compliance with cGMPs, Regulatory, and BLPs guidelines. Job assignments are to ... be completed with supervision of a Validation or Project Manager . Assume the responsibility for the cGMPs and Environmental Health and Safety procedure awareness,… more