Amy P. N.
Senior Manager, Quality Assurance
- Role
- Senior Manager, Qa Compliance at Nitto Avecia Pharma Services
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Amy P. N.
Professional Certificates: Lean Manufacturing, Quality Auditor, LIMS Admin, PDA Sterile/Aseptic Pharmaceutical Manufacturing, Leadership Development• Quality oversight to all manufacturing operations in support of clinical and commercial products, which include implementing procedures to prevent microbial contamination, cross-contamination and product mix-ups; investigate lot failures, out-of-specification results and ways to implement corrective actions.• Hybrid competent. Remote collaboration tools: manage remote employees using Zoom, MS Teams, Webex.• Scope: Ensure and maintain Quality Systems to meet all Accreditation requirements; manage all aspects of client, internal and external audits; prepare and conduct quarterly Quality Management Review; manage complaints, QA/GMP training, competency, proficiency testing, quality documents; develop and administer risk based approach to supplier management.• Supported 3 facility remediations due to voluntary consent decree and Warning Letter• Optimized QC lab set up, analytical testing and manufacturing batch records to run 3 Phase II cancer vaccine clinical trials and approval of one orphan drug.
Experience
Senior Manager, Qa Compliance
Apr 2019 — Present · Irvine, CA, US
Remote collab tools- manage staff remotely using Zoom, Teams, Webex, Sharefile.Lead all client, internal and regulatory audits; renew all associated licenses and registrations.Entire system overhaul of Quality Supplier Management Program
Education
UCLA
BS, Molecular Genetics and Microbiology
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