- Cardinal Health (Tallahassee, FL)
- …with regulations set by agencies such as the US Food and Drug Administration ( FDA ) and the European Union under the EU 2017/745 Medical Device Regulation (EU MDR) ... IL location.** **Responsibilities** + Interpret complex regulatory requirements (eg, FDA 21 CFR Part 820, 21 CFR Part 11,...used for GxP data to ensure they comply with FDA 21 CFR Part 11 regarding electronic records and… more
- Cardinal Health (Tallahassee, FL)
- …You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team develops ... the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical requirements in… more
- Teva Pharmaceuticals (Weston, FL)
- …from manager. . Write, review and compile documentation necessary for responses to FDA Deficiency letters. . Write, review and compile documentation and data for ... . Review applicable revised and new regulations and guidance's distributed by FDA . . Train on internal SOPs (Standard Operating Procedure) and requirements as… more
- AbbVie (West Palm Beach, FL)
- …with regard to schedule management and follow-up skills are required. Knowledge of FDA GMPs. Ability to function in a controlled environment regulated by FDA ... is required. Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations,… more
- Kelly Services (Jacksonville, FL)
- …You will be instrumental in improving equipment performance, ensuring compliance with FDA , ISO, and GMP standards, and supporting the deployment of innovative ... reliability. + **Regulatory Compliance** Ensure all automation systems comply with FDA regulations, ISO standards, and GMP requirements specific to medical device… more
- AdventHealth (Orlando, FL)
- …in accordance with trial protocols, Food and Drug Administration ( FDA ) regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) ... institutional IRB approved informed consent (IC) document, according to current FDA , state, federal and institutional regulations with study candidates and/or legal… more
- Justrite Safety Group (Brooksville, FL)
- …to resolve quality-related issues. + Support internal and external audits (eg, ISO, FDA , customer audits). + Monitor and analyze quality metrics to identify trends ... training programs. + Ensure compliance with regulatory standards (eg, ISO 9001, GMP, FDA , etc., depending on the industry). + Manage and maintain calibration and… more
- Grifols Shared Services North America, Inc (Kissimmee, FL)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. + Attend… more
- Cordis (Miami Lakes, FL)
- …process validation (IQ/OQ/PQ) activities, ensuring compliance with ISO 13485 and FDA QSR requirements. + Troubleshoot and resolve extrusion process issues, ensuring ... setup. + Experience with cleanroom manufacturing and compliance to ISO 13485 and FDA 21 CFR Part 11/QSR. + Proficiency with statistical analysis tools and process… more
- Actalent (Coral Springs, FL)
- …of experience. + Proficiency in HPLC, UPLC, and UV-Vis techniques. + Familiarity with FDA and GMP regulations. + Ability to analyze and interpret complex data. + ... laboratories. Work Environment This position is based in a lab environment regulated by FDA and GMP standards. The work schedule offers flexibility with a 1st shift… more