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Hayward, CA
... with supporting documentation such as Independent Cost Estimate Purchase (ICE), Scope of Work, Quote Tabulation, Sole Source Justification, Cost Analysis (short form for Sole Source Contracts), FTA Require- ments if FDA, Contract Notification. ...
- 2022 Dec 17
San Francisco, CA
... p) I had helped clients to remediate FDA 483 and warning letters. q) Had performed many quality audits both internal and external. r) Had interacted with FDA officers many times. s) I can speak and write three languages English, Chinese (Speak, read ...
- 2022 Dec 16
La Honda, CA, 94020
... device industries with demonstrated competencies in the following areas: FDA 21CFR Parts 11, 820 and 111, ISO 13485, MDSAP and ISO 14971 Medical Device Standards and cGXP requirements pertaining to medical devices and IVD laboratory developed tests. ...
- 2022 Nov 30
Fremont, CA
... • Staff Software Engineer / Consultant @Element Science, Inc Sep 18 – Dec 18 * Executed the software engineering verification for a FDA regulated class C Data Analysis Application Software (as a class3 life-saving medical device). * Improved & ...
- 2022 Nov 29
Fremont, CA
... clients’ procedures and international drug safety regulations including- ICH guidelines on safety and efficacy, Volume 9A, FDA guidelines, CIOMS, new EU PV legislation Drug Safety Associate, Johnson & Johnson Pharmaceuticals, New Brunswick, NJ Sep ...
- 2022 Oct 19
San Rafael, CA
... Localized all Japanese skin care products to comply with FDA regulations for U.S. launch. Developed wholesale distribution channel to the Chinese and Korean markets. Supervised Japanese Customer Service Representatives, Administrators Managed ...
- 2022 Sep 23
San Francisco, CA
... Bayer Healthcare LLC, Berkeley CA August 2014 – February 2015 Data Collection Associate, FDA Observation 1 Team ● Perform data queries and functions in MES, LIMS, SAP, SCORE in order to review, verify, validate past manufacturing, packaging, QC and ...
- 2022 Sep 10
San Carlos, CA
... to pull Data from SAP using Shell Scripts, PL/SQL and SQL Loader • Development of Custom Applications using Developer 6i/9i • Database validation using DQ, IQ, OQ and PQ for FDA Validated Systems • Application Support for Clinical Applications eg. ...
- 2022 Aug 05
Hayward, CA
... -Adhered to general safety rules, manufacturing procedures, company policies and procedures, QSR AND FDA regulations. SHIPPING AND RECEIVING CLERK- LEAD - Over 10 years hands on experience in shipping and receiving clerk capacity - Certified ...
- 2022 Jul 07
Oakland, CA
... Directed safety operations and maintained clean work environment in adherence to FDA and OSHA requirements. Delivered and implemented staff engagement, gender diversity and cultural programs alongside robust reporting tool, improving operational ...
- 2022 Jun 15