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Charlotte, NC
... US FDA audit was successfully completed twice without any observation from the inspection and packing department. Similarly, TGA audit was also concluded without any observations at Mylan Laboratories Limited. Successful implementation of ...
- 2018 Nov 19
Charlotte, NC
... CMMI course certificate FDA Quality Assurance Seminars and certifications AAMI Verification and Validation Seminars and certifications Quality Assurance Institute – C.S.T.E. Certified Software Test Engineer Continua Health Alliance (medical device ...
- 2018 Sep 21
Charlotte, NC
... development, maintenance, and support of JD Edwards applications for manufacturing, distribution, inventory, and sales order modules for Greer Labs via a strict protocol upon verification of scripted testing and in accordance with FDA regulations. ...
- 2018 Jul 25
Charlotte, NC
... Worked with the Quality Assurance group to ensure all systems, including Spectrographic, Chromatographic and Dissolution apparatus were within FDA compliance. Installed, validated, calibrated and operated two Zymark Tablet Processing Workstations ...
- 2018 Jun 06
Charlotte, NC
... * Performed technical and GMP gap assessment of quality system against ISO 13485 standards and FDA 21 CFR Part 820 requirements and developed/ revised/ enhanced procedures in preparation for pending ISO audit and planned product transfer to a ...
- 2017 Dec 13
Charlotte, NC
... FDA Responses-Complete response letters, problems encountered during drug manufacture, safety, efficacy, bioequivalence, stability, quality of final product, labeling. Research experience Duke University medical research scientist, carrying out ...
- 2017 Oct 05
Charlotte, NC
... Controls, Risk Management, CAPA, Post-market Surveillance, Writing Validation Protocols- IQ/OQ/PQ/ SOP’s, Process Validation, Master Validation Plans, Pro-E, Remediation, PFMEA, 21 CFR Part 820 - Quality System Regulation (QSR), FDA and Gage R&R. ...
- 2017 Aug 14
Charlotte, NC
... and customers Recall Administrator, leading customer communication and collection of required documentation in collaboration with FDA requirements Microstrategy Super User, managing the integrity and reporting of data for Fresh Express Operations, ...
- 2017 Aug 08
Charlotte, NC
... Documented according to FDA standards. Manufactured device using circuitry analysis and Solidworks. Portable syringe pump, May 2016 – June 2016 Designed a portable insulin syringe pump using Solidworks and produced a functional syringe pump with a ...
- 2017 Aug 05
Charlotte, NC
... Application allowed FDA quick, flexible access when evaluating drug. 1988-1989 Allied Signal Assisted various groups in SQL specification and optimization; SQL*Forms instruction; taught SQL course to various divisions. Fortex Corporation 1986-1987 ...
- 2017 Feb 16