- HCA Healthcare (Fort Pierce, FL)
- …other environment of care functions as defined by JCAHO, CARF, OSHA, EPA, FDA , FDOH and other regulatory agencies. Demonstrates Competency in the Following Areas: ... Serves as the Facility Safety Coordinator. Provides consultation regarding safety issues upon request to any department, committee, or task force. Serves as Environment of Care Committee Coordinator under the direction of the Facilities Director, with overall… more
- Bausch + Lomb (Tampa, FL)
- …QC Laboratory instruments at Tampa site to assure compliance with cGMPs/GLPs/GAMP/ FDA , 21 CFR Part 11, Data Integrity, and Regulatory guidelines/requirements. This ... role will provide compliance oversight for the QC Laboratory software systems installed at the Tampa site. **Key Activities/Responsibilities:** + Act as system administrator for local QC Laboratory software systems. + Continuously monitor and maintain basic… more
- Bausch + Lomb (Tampa, FL)
- …applicable regulatory requirements and site standards such as but not limited to ( FDA , cGMP, ICH, etc.) and internal policies. This role supports internal and ... external audits, maintains compliance documentation, and drives continuous improvements related to inspections readiness initiatives. Responsible for various Quality System process improvements and Quality Assurance/System projects, which will require… more
- Cardinal Health (Tampa, FL)
- …sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (ie FDA , NRC, DOT) to support patient treatment through disease diagnosis, ... staging, and monitoring. The primary work environment consists of a cyclotron and associated manufacturing facility for the production of PET radiopharmaceuticals, which must be kept clean, orderly, properly lighted and maintained in optimum operating… more
- Lundbeck (Miami, FL)
- …including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... **REQUIRED EDUCATION, EXPERIENCE and SKILLS:** + Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university + 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience +… more
- ZOLL Medical Corporation (Miami, FL)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more
- Cardinal Health (Deland, FL)
- …and continually improve the Quality Management System in compliance with ISO 13485, FDA QSR, and other relevant standards. + Manage internal audits, external audits, ... and regulatory inspections. + Oversee document control, CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and complaint handling. + Support risk management activities, including hazard analysis and FMEA. + Ensure quality oversight… more
- Danaher Corporation (Miami, FL)
- …content for consumables product labeling. . Manage new labeling projects to meet FDA , EU, IVDR, ISO, CLP/GHS, and other countries' regulatory requirements. . Support ... the management of labeling change control processes, including document version control and archival. . Coordinate time with graphic designers and technical writers to assist with proofreading and formatting documents to ensure consistency and adherence to… more
- CSL Plasma (Miramar, FL)
- …donor disconnect. 2 In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. 3 Evaluates ... vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the… more
- Terumo Aortic (Sunrise, FL)
- …to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA + Prepare and submit medical device reports or vigilance reports. + ... Perform various other duties as assigned. DIMENSIONS & LIMITS OF AUTHORITY COMPANY REQUIREMENTS + Must work within requirements of company handbook and policy statements. Note: Company Handbook, Policy Statement and Authorisation of Limits do not form part of… more
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