Yniska Gaines

Audit Manager, Johnson&JohnsonPharma and Med Device Quality Professional: Regulatory Compliance | Quality Systems | Validation | Engineering Compliance | Six Sigma

Role
Audit Manager - Global Regulatory Compliance at Johnson & Johnson
Location
Los Angeles, CA, US
LinkedIn followers
500 followers

About Yniska Gaines

ASQ CQA; BSI Certified Lead Auditor ISO 13485 and 19011; Quality Validation; Supplier Quality; Compliance Lead; CAPA and Deviations; Regulatory Compliance; Continuous Improvement Leader; Lean Green Belt, SSGB; Deviation investigation management

Experience

  1. Audit Manager - Global Regulatory Compliance

    Johnson & Johnson

    Aug 2021 — Present · Orange County, CA, US

    Ensures the effectiveness of the JJRC (J&J Regulatory Compliance) quality audit program by performing the following- Conduct quality audits and gap assessments of J&J manufacturing sites - Conduct external manufacturer and supplier quality audits- Support regulatory health inspection readiness- Develop and execute organizational and operational policies for the supplier quality audit program

Education

  • California State University, Los Angeles

    Bachelor of Science (BS), Biology

    2008

  • California State Polytechnic University-Pomona

    Master of Biotechnology (MBt), Applied Biotechnology

    2014 — 2016

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