Senior Auditor, Pharmaceutical Quality Assurance
Resume:
Leslie Howard Hubbard
Clayton, NC 27520
Day/Evening Phone: 919-***-****
*******.*******@*****.***
Work Experience
Senior Auditor, Quality Assurance; Catalent Pharma Solutions, Morrisville, NC
2012-present
Laboratory Investigation Report reviews: Out of Specification and Aberrant/Atypical Data Investigations, laboratory error reports, deviations, Corrective and Preventative Action plans and Trackwise Problem Reports; review for accuracy, completeness and compliance with internal SOPs and applicable regulatory standards.
Annual Product Review reports for commercial product customers.
Audit final laboratory reports for accuracy and compliance with internal SOPs, protocols and regulatory requirements. Audit and approve laboratory methods and customer protocols for compliance. Conduct in-process, internal and laboratory walkthrough audits. Prepare completed data packets for archival.
Auditor, Quality Assurance; Catalent Pharma Solutions, Morrisville, NC
2006-2012
Audit of final laboratory reports for accuracy and compliance with internal SOPs, protocols and regulatory requirements. Audit and approve laboratory methods and customer protocols for compliance. Conduct in-process, internal and laboratory audits to assess for GLP/GMP regulatory compliance. Prepare completed data packets for archival.
Procedures Associate; Cardinal Health, Morrisville, NC
2005-2006
Coordinate, revise, write SOPs, ICPs, IQSs. Primary focus was assisting laboratory staff with document revision and approval procedural tasks.
Laboratory Assistant; UNC-CH Department of Genetics, Threadgill Laboratory
February to October 2004
Bacterial genetics and microbiology research
Skills acquired included aseptic technique, SDS-PAGE, gel electrophoresis, PCR amplification, spectrophotometry, bioinformatics tools, bacterial hybridization and mammalian cell culture.
Validation Technician; Nortel Networks, RTP, NC
1999-2003
Build-out, upgrade, test, validation and delivery of multimillion dollar international optical data networks in a team oriented, goal driven environment with continual customer contact.
Inorganic Chemist I/Radiochemical Technician II; CompuChem Labs, Cary, NC
1991-1998
Inorganic and radiochemical sample preparation and analysis, logbook and batch record maintenance, new employee training, SOP revisions, procedure validations, data reporting, instrument maintenance & calibration, process troubleshooting and laboratory safety.
Research Assistant; Chathamborough Research Group, Inc., Pittsboro, NC
1982-1990
Sole responsibility for literature search reviews for medical device PMA and 510k submissions. Team oriented final review of FDA submissions for accuracy, consistency and logical flow.
Education
B.A. Biology, UNC-Chapel Hill
Telephony & Network Engineering, Wake Technical Community College
Other Activities
Board Member, Clayton Downtown Development Association 2005-Present
Board of Directors, Clayton Farm and Community Market 2008-Present
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