Quality Control Manager
Resume:
Jeffrey D. Bentley
BACKGROUND SUMMARY
Analytical Chemist with over six years experience in method development,
identification, and analysis of compounds, in complex to simple matrices at
the trace, micro, and macro levels by using a variety of modern and
classical techniques. Supervised other analytical chemists to ensure the
quality and timely completion of their analyses.
Raw Material Manager and Supervisor, accomplished at raw material testing
in an FDA regulated environment. Extensive background in compendial
testing.
Compliance Specialist for a global pharmaceutical contract manufacturer,
focused on product development quality assurance. Experienced at
conducting internal and external audits. Supported clinical supplies
manufacture through all phases of development and production.
PROFESSIONAL EXPERIENCE
BANNER PHARMACAPS, High Point, NC (10/2006 to 8/2008)
Quality Control Laboratory Supervisor (10/2006 to 8/2008)
. Responsible for the proper and timely testing of raw materials
. Conduct Out-of-Specification investigations and create CAPA items
. Train QC personnel in analytical techniques and cGMP compliance
. Diagnosing problems with chromatographic instrumentation
. Mentoring and supervision of raw material chemists
NOVARTIS ANIMAL HEALTH, Greensboro, NC (5/2005 to 9/2006)
Quality Specialist I (5/2005 to 9/2006)
. Batch record review and evaluation
. Assign final disposition to finished drug products
. Review and approve analytical method protocols and reports
. Track and trend finished product analytical release data
. Laboratory Investigation report review
. Facilitate Annual Product Reviews and MCSR submissions to the FDA
. Evaluate product defect complaints and adverse drug experience reports
BANNER PHARMACAPS, High Point, NC (6/1997 to 3/2004)
Raw Materials Manager, Quality Control (6/2003 to 3/2004)
. Responsible for the proper and timely testing of all raw materials
. Conduct Out-of-Specification investigations
. Schedule workflow and personnel resources to accomplish rapidly changing
production schedules
. Train QC personnel in analytical techniques and cGMP compliance
. Modify or create raw material specifications and written procedures
Special Project, Quality Control (9/2002 to 6/2003)
. Update and transfer analytical methods, raw material and finished product
specifications, and written procedures from California facility to High
Point facility
. Assist in the transition from paper-based document control to electronic
document control
Compliance Specialist (12/1999 to 9/2002)
. Function as the Quality Control Unit for Product Development
. Review and release raw materials and finished products
. Audit external laboratory and packaging contractors for cGMP compliance
. Perform internal cGMP audits
. Review and approve clinical batch production records, perform quality
clearances during clinical supply production and release clinical supply
materials to the clinic
. Train Product Development personnel in cGMP compliance
. Develop written procedures for cGMP compliance
Quality Control Laboratory Supervisor and Chemist III (6/1997 to 12/1999)
. Supervise second-shift operations in the Quality Control Laboratory
. Train QC personnel in analytical techniques and cGMP compliance
. Perform extensive raw material testing according to USP/NF, FCC, AOAC,
and AOCS
. Create internal auditing programs
. Troubleshooting and repair of chromatographic instrumentation
. Review notebooks and train other personnel in proper notebook review
. Modify specifications and methods to meet changing requirements
PROCTER & GAMBLE, Greensboro, NC (12/1993 to 3/1996)
Technician (Analyst), Quality Control Laboratory - Respiratory Care
(12/1993 to 3/1996)
. Perform routine instrumental analysis of pharmaceutical products
. Investigate Out-of-Specification analytical results
. Conduct USP/NF testing of raw materials
. Train other analysts in chromatographic instruments, technique, and
theory
. Perform routine and in-depth instrument maintenance
. Create audit logs and operational manuals for chromatographic instruments
. Perform upgrades and optimization of laboratory automation
INSTRUMENTATION EXPERIENCE
. Gas chromatographs with FID, TCD, ECD, and MSD detectors, capillary and
packed columns, with both conventional injection and headspace sampling.
. High Performance Liquid Chromatographs with UV, RI, and ELSD detectors on
quaternary-solvent gradient systems
. Flame Atomic Absorption Spectroscopy
. Digital Scanning Calorimetry and Thermogravimetric Analysis
. Fourier-Transform Infrared and UV-Visible Spectroscopy
. Automated titrators (Mettler and Brinkmann)
COMPUTER SYSTEMS/SOFTWARE
Proficient in Windows, Linux, and OS X. Application fluency in Microsoft
Office, FoxPro, FileMaker, VG Multichrom, Agilent's ChemStation, and Thermo
Electron's Atlas.
EDUCATION
B.S. Degree, Chemistry, May 1991
Guilford College, Greensboro, NC
3803 Waynoka Dr, Greensboro, NC 27410
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