Antioch, CA, 94509
... QA/QCSpecialist — Yamanouchi PharmaceuticalsPalo Alto] 1998–2001 • Oversaw quality assurance and quality control activities in compliance with FDA GMP standards. • Led equipment validation projects following facility relocation, ensuring seamless ...
- Jul 03
San Diego, CA, 92130
... Werfen- San Diego, CA 06/2020- 01/2022 Senior Systems Verification Engineer Conducted system-level testing of medical diagnostic instruments to FDA and ISO-13485 standards. Executed environmental reliability tests using ReliaSoft Weibull++. Improved ...
- Jul 02
Ambler, PA
... by 75% Global Director of Lean Six Sigma ABBOTT LABORATORIES 2003 - 2005 Implemented a world-class Business Excellence program (DMAIC, Lean Manufacturing, and DFSS) into Abbott Diagnostic’s business within the confines of GMP and FDA oversight. ...
- Jul 02
Germantown, TN
... Peninsula Cardiac Clinic, Salisbury, MD 08/01/2007 – 09/31/2007 • Performed testing for the FDA confirmation of the Abbott i-stat for BNP testing P.E.P.F.A.R Zambia, Africa Trained Medical Technologist in Quality Control, use of Laboratory ...
- Jul 02
Washington, DC
... Research Associate/Quality Control Oversight - Controlled Human Malaria Infection § Quality Assurance Lead - SOP compliance, procedure documentation, COA tracking § Trial Master File - FDA regulations, quality assurance tracking and documentation. ...
- Jul 02
San Jose, CA
... • Working knowledge of ISO-13485 and FDA Regulations for Manufacturing and product testing. • Using soldering iron, power hand drill, dremel and all type of small hand tools etc. Global Advanced Technologies, LLC 09/2015 – 07/2016 (Contract) Senior ...
- Jul 02
Brampton, ON, Canada
... Post assessment - facilitated guidance for solutions implementation and establishing IT controls to comply with HIPPA, FDA and FOIP requirements and standards. ●JUN 2007 - APR 2009: Enerflex (Lead IT Governance & Control) Calgary, Canada DEC 2005 - ...
- Jul 02
Albany, NY
... Schedule production based on customer demands and FDA guidelines. Safety- responsible for safety of themselves and teammates. Operation of the packing/bagging machines. Stacking bags and basic maintenance of bagging equipment. Sampling and labeling ...
- Jul 02
East York, PA, 17402
... Directed all technical and operational aspects of the project to ensure compliance with FDA regulations. Managed a Phase III, 750 patient global trial in malignant melanoma. Conducted clinical trial audits and managed the CRA trip monitoring reports ...
- Jul 02
Salt Lake City, UT
... R&D Technical Writer Fresenius Medical Care October 2012 to March 2021 Prepared R&D documents associated with medical device design and manufacture, such as publication submissions, FDA compliance documentation, labeling, test plans, protocols, ...
- Jul 01