Phillip Harris Email & Phone Number

Wilmington, OH

• 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

Greater St. Louis Area

• Review and Approval of GMP documents (SOPs, Stability Protocols and Change Controls) for Clinical and Commercial Production facility.
• Review and Approval of deviation investigations regarding QC, Facility, Metrology, Engineering and Production deciding product impact, and appropriate CAPAs
• Train personnel on CAPA and deviation investigation procedures
• Member of CAPA Effectiveness Team, Change Control Task Force Team, Trackwise Re-Development and Implementation Team
• Batch Disposition duties i.e. comprehensive investigation reviews
• Revision of CAPA and deviation investigation procedures

Dublin, Ireland

• Review and Approval of GMP documents (SOPs, Validation Protocols, and Change Controls) for Start-Up facility.
• Chairperson for various Change Control Committees (Laboratory and Production)
• Train personnel on procedures relevant to Change Control
• Perform Gap assessments between Corporate Policies and Departmental SOPs
• Reporting of Performance Metrics
• Member of Automated Change Control Tracking System (Trackwise) Implementation Team

Greater St. Louis Area

• Review deviation investigations regarding QC and Productions issues for content, determination of product impact, and CAPAs
• Facilitation of Raw Material Change Control meetings
• Train personnel on deviation investigation procedures
• Review and Disposition of Quality Batch Records
• Handling of deviations related to validation protocols
• Project work for start-up facility in Dublin, Ireland

Kalamazoo, Michigan Area

• Perform complaint investigations regarding prescription and over the counter medications
• Facilitation of weekly staff meetings
• Communication with manufacturing personnel regarding quality issues

Kalamazoo, Michigan Area

• Perform assays using Chromatography and Spectroscopy instruments
• Conduct scheduled maintenance
• Technical Writing of R&D analysis
• Authoring Lab Analyst Training Program

Bachelor Of Science, Chemistry - Major And Mathematics - Minor

Activities and Societies: Chemistry Club

Six Sigma Black Belt

Xavier Consulting Group Certifications Project Management Six Sigma Black Belt