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El Cajon, CA, 92019
... System Test Engineer Jul 2019-Apr 2020 Philips Health (SSI) San Diego, CA •Created FDA approved test cases based upon the product requirements and stories using HP/MF-ALM (Quality Center). •Tested the various FDA class 1 and class 2 devices such as ...
- Feb 05
San Diego, CA
... ●Working on multiple CAPA’s for Infusion and dispensing and several FDA related projects. ●Leading projects to completion and working with core teams to deliver process excellence. ●Development and release of new SWI’s/MP’s/MBI’s/CO’s ●Well versed ...
- Jan 26
San Diego, CA
... • Successful FDA approvals for three BOTOX indications; glabellar lines, hyperhidrosis and migraine headache. • Successful clinical validations of over 50 assays, including EUA for Quest COVID-19 At-Home Rapid Antigen Test. • Therapeutic experience ...
- Jan 21
San Diego, CA
... Maintains accurate documentation, records and logs in accordance with FDA (Food and Drug Administration), GMPs (Good Manufacturing Practices) and ISO13485 (International Organization for Standardization). Perform in depth troubleshooting and problem ...
- Jan 18
San Diego, CA, 92101
CARL KEITH EDWARDS, III, PHD (m)760-***-**** (h)951-***-**** ad2u84@r.postjobfree.com Temecula, CA 92592 linkedin.com/in/drcarlkedwardsiii Biopharmaceutical Leader Drug Discovery, Development, Preclinical, Clinical FDA Regulatory Global Leadership & ...
- Jan 17
San Diego, CA
... • Experienced in government DoD, FDA, and Quality Control Regulations • Utilizes skills in Microsoft Office, JPAS, SharePoint, AutoCAD, 360Facility and SAP. • Currently possess an Active Security Clearance Employment Highlights Amentum, San Diego, ...
- Jan 17
San Diego, CA
... • Provided supporting documentation to FDA for the successful approval of Hygeia’s first IND for its anti-colorectal cancer therapeutic. Included in IND were reports on market size and targeted market segment. • Attended scientific conferences and ...
- Jan 16
San Diego, CA
... Troubleshooting/Testing/V&V/Documentation FDA regulations, Security, Design and Quality Control, Risk analysis, GMP, FIPS, CVE, HIPAA Education BUDKER INSTITUTE OF NUCLEAR PHYSICS (BINP) – NOVOSIBIRSK, RUSSIA Ph.D. in Physics NOVOSIBIRSK STATE ...
- Jan 12
San Diego, CA
... Types of Testing (not limited to): Validation (FDA), Verification (FDA), Verification and Validation (FDA), Verification and Validation (DOD,) Reliability, Web based and desktop applications to include: Unit, functional black box, white box, ...
- Jan 08
San Diego, CA, 92101
... Successfully increased inventory management practices, identifying process improvements while ensuring delivery of products in alignment with FDA mandated 5-month supply reserves. Provided leadership throughout multiple projects, documenting testing ...
- Jan 04