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Jacksonville, FL
... to ensure device meet ISO, and ASTM standard ● Prepared and documented DHF and DMR for the project ● Developed Federal Regulation(FDA) Pathway using 510k, PMA filling processes and GDP for the project ● Modeled device’s drawings and assemblies using ...
- 2020 Oct 14
Jacksonville, FL
... Manage supplier expectations and communications, track performance and provide timely feedback via documentation in compliance with FDA and ISO. Lead plant supplier performance reviews and forums. Support corporate supplier reviews and forums and ...
- 2020 Feb 20
Jacksonville, FL
... audit of the plant Conducting analytical testing on all raw materials, semi-finished goods, and finished goods to ensure that FDA standards and company specifications were met Adjusting any product that did not meet FDA and/or company standards in ...
- 2019 Mar 05
Jacksonville, FL
... meetings with major sponsors discussing topics such as queries, data, & audits Led team meetings for each service which included trainings, compliance with FDA, GCP and QA regulations Planning, Management and execution of biosimilar programs. ...
- 2018 Dec 10
Jacksonville, FL
... Completed multiple projects following BIMBA, FDA, CE, UL standards. Designed LEAN cost saving manufacturing practices. Continually update CAD models and the connected ERP BOM’s. Continuous training in SolidWorks, AutoCAD, and Made2Manage. Kellogg ...
- 2018 Oct 07
Jacksonville, FL
... Lead safety policy, initiatives, and processes to proactively identify and mitigate risks, ensuring compliance with Florida Department of Health, DEA, FDA and CTPAT agencies. Maintain physical inventory with annual adjustments of less than 12K (.01% ...
- 2018 Sep 23
Jacksonville, FL
... Maintained device history files and gathered information to ensure compliance with FDA Design Control regulations and to support 510(k) submissions. Worked closely with spine surgeons In order to provide them with custom implants and instruments to ...
- 2018 Sep 15
Orange Park, FL, 32073
... for Cleanliness and Neatness of Work Area * Maintaining a consistent level of efficiency on the Donor Floor * Knowledgeable of FDA, EU, OSHA, CLIA, COLA, IQPP and Customer regulations and SOP Procedures pertaining to the Donor Floor General Manager ...
- 2018 Jan 17
Jacksonville, FL, 32256
... Led FDA compliance program across all AGROCON warehouses and successfully met audit requirements which resulted in savings of over $250,000.00 from 2012-2017. Implemented cost analysis programs and reduced warehousing and inland cargo transportation ...
- 2017 Dec 11
Jacksonville, FL
... opportunities, and sales rep requests Worked with government agencies such as the Division of Professional Regulation, FDA, and Board of Pharmacy for the set-up of pharmaceutical sales in all 50 states with my Certified Designated Rep License ...
- 2017 Aug 17