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Wesley Chapel, FL
... and 21cfrp11 efficiently while lowering costs of data exchange between systems Responsible for systems regulatory compliance (FDA, SOX, PCI, GCP), client and vendor relationships as well as budget management for a $8 million-dollar annual technology ...
- Jan 14
New Port Richey, FL
... Functioned as both the Administrator and Trainer for several 21 CFR Part 11 compliant software programs and creator of several Standard Operating Procedures, which dealt with the installation, back-up, restoration, and general usage for several FDA ...
- 2020 Sep 23
Clearwater, FL, 33764
... FDA testing methodology on home use dialysis machines. (ESD) environment Computerized testing procedures for Electrical, Temperature and Vol. Accuracy . Manufacturing Maintenance Mechanic Technician 9/24/2014-11/21/2017 Compulink Cable Assemblies ...
- 2020 Apr 11
... & Critical Control Points) oFSMA (Food Safety Modernization Act) oPasteurized Milk Ordinance (PMO) oUS Food & Drug Administration (FDA) oGood Manufacturing Practices (GMPs) oStandard Operating Procedures (SOP) Comply with all Company policies; ...
- 2020 Feb 26
... ● Assisted with annual FDA audit preparation. Education Diploma, Gibbs High School 1979 Skills ● Excel, Word and Office experience. ● CMM experience using Zeiss Calypso and PC DMIS software. Certifications ● Zeiss Calypso 2004 - present ● GD&T 2004 ...
- 2019 Mar 19
Largo, FL, 33778
... Subject matter expert in ISO 9001 and FDA compliance with proven strengths in driving achievement of corporate quality objectives. Known for achievements in earning high customer satisfaction ratings while increasing productivity. Trained in Gallup ...
- 2018 Dec 06
... for requests that meet FDA indicated diagnoses and CMS guidelines ●Escalate denials and requests requiring extensive clinical review to pharmacists ●Develop reports and provided them to providers, and/or management Data Entry Technician Dec. ...
- 2018 Oct 08
... 8/2014-1/2015, (Contract) Technical Editor/Writer, Actavis Laboratories FL, Inc., Davie, FL In support of Pharmaceutical Technologies, ensured compliance with the FDA current Good Documentation/Manufacturing Practices (cGD/MPs). Updated Bottle ...
- 2018 Oct 01
Palm Harbor, FL
... Develop train and manage audit teams to ensure FDA, GMPs and ISO compliance. Assemble and lead process improvement teams to resolve issues, improve/optimize existing functions. Spearhead and develop cost saving initiatives /projects. Lead and ...
- 2018 Sep 14
Safety Harbor, FL, 34695
... SUMMARY OF QUALIFICATIONS: Auditing, FDA, FAA, QMS, QSR, ISO, AS, Regulatory Affairs, Complaint Investigation, CAPA, Documentation, Statistical Process Control, Equipment Calibration, Inspection, G, D & T, Supplier Surveillance (SQE), Lean ...
- 2018 Aug 27