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
Audit Manager - Global Regulatory Compliance
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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