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Emeryville, CA
... ATANU SEN Emeryville CA 1-305-***-**** adyzkk@r.postjobfree.com Summary Accomplished Validation Engineer with 7 years' experience catering to FDA and CLIA regulated healthcare and pharmaceutical Fortune 200 and 500 clients. Experience in cost ...
- 2023 Aug 16
San Francisco, CA
... Led organizations through quality compliance upgrades and participated in numerous successful pre-approval inspections (FDA and EMA). Thorough knowledge of 21CFR 210/211, 21 CFR 820, ISO 13485 as well as TS16949 and ISO 9001 quality standards Expert ...
- 2023 Aug 08
San Francisco, CA
... Proficiency in validating, auditing and preparing SOPs for Pharmaceuticals and medical devices as per FDA regulations and providing corresponding user training. Well experienced in writing technical documents such as Risk Assessment, Work ...
- 2023 Jul 30
Berkeley, CA
... Facilities Floor Plans / Projects Facility - New Build-Out Move-In Decommissioning & Closure FAQs Frequently asked questions FDA GxP QMS EQMS Trackwise Feasibility analysis Fees Field Operations Finance Accounting Financial Products Deployment (From ...
- 2023 Jun 20
Santa Clara, CA
... Enforce - through functional groups - document control requirements in order for Ariosa to meet internal and external needs according to CLIA/CAP, NY, ISO 13485, IVDD, and FDA (QSR) regulatory standards including all applicable local, state, ...
- 2023 Jun 20
Berkeley, CA
... Degree- Chemical /Electrical Engineering Condi College Campbell CA Certificate EP, FDA, Phoenix Chemistry Oxidation, AZ/MAT Safety, OSHA CCNA IT University Experience: Tdk Headway technology, Milpitas CA 4/2/18 - current Lab Engineer Use of Endpoint ...
- 2023 May 30
San Francisco, CA
... Audited and ensured production area was in compliance with ISO, FDA and internal regulations. Actively took part in NCR’s, DA and ECOs. Actively produced report using power point and Microsoft excel in daily, weekly and monthly meetings. Prevented ...
- 2023 May 27
San Francisco, CA
... and resource scheduling resulting in improved resource allocation Increased performance of customer-facing, data-driven, FDA compliant websites for pharmaceutical trials by more than 20x (database and page optimization) while reducing code volume ...
- 2023 May 27
Fremont, CA
... Created Patient narratives and generated .XML outputs for FDA regulatory submissions. Worked closely with team Statistician and prepared Adhoc reports for analysis. Created edit check programs to find data discrepancies in raw datasets. Programed ...
- 2023 May 25
San Francisco, CA, 94102
... Business / quality systems expertise: FDA-QSR (21CFR820/210/211), Automotive PPAP-ITAF 16949 & Aerospace AS-9000 / Commercial standards as well as latest Medical Device ISO 13485-2003 revision to ISO13485-2016 / MDSAP, EU-MDR/IVDR updates, and ...
- 2023 May 19