Phillip Harris

Experience

1. Sr Quality Associate

   Alkermes

   Apr 2006 — Present · Wilmington, OH, US

   Full List of Job Activities• Review and Approval of GMP documents: SOPs, Batch Records, Validation Protocols, Change Controls, etc.• Review and Approval of Deviation Investigations for QC, Facilities, Metrology, Engineering, and Production deciding product impact, root cause analysis, and appropriate CAPAs• Mentoring of QA Associates including distribution of workload and explaining finer points of quality: root cause/capa relationship; risk based approach to quality; • QA Lead for Startup of New Production Lines• Regulatory Inspection support and assistance with response follow-up• Performance of Internal Audits and Supplier Audits• Six Sigma Project Facilitation and Execution• Metrics Reporting• Supervision of Third Party Manufacturing Activities• Recall Event Coordination and Documentation• Authoring of Annual Product Review

Education

• Xavier Consulting Group

  Six Sigma Black Belt

  2007 — 2007

• Western Michigan University

  Bachelor of Science, Chemistry - Major and Mathematics - Minor

  1997 — 2001

Skills

• Batch Records
• Regulatory Requirements
• Complaints Handling
• Certified Project Manager
• Standard Operating Procedure (Sop)
• Cgmp
• Cgmp Practices
• Manufacturing
• Biotechnology
• Cleaning Validation
• Pharmaceutical Industry
• Sop
• Fda
• Validation
• Documentation
• Auditing
• Technical Writing
• Capa
• Fda Gmp
• Sop Development
• Investigations
• Batch Release
• Supplier Quality
• Deviations
• Quality System
• V&V
• Aseptic Technique
• Internal Audit
• Quality Control
• Trackwise
• Gmp
• Computer System Validation
• Six Sigma
• Gxp
• Equipment Qualification
• Quality Auditing
• Aseptic Processing
• Quality Assurance
• Regulatory Submissions
• Change Control