Quality Control Manager

Robert Bost

Home: 719-***-**** *** Leo Drive,

Hamilton, OH 45013-1420

*******@*****.***

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Summary

Quality professional possessing 15 years of experience in

pharmaceutical and specialty chemicals QC/QA laboratory leadership.

Excels at maintaining an audit ready laboratory, building teams and

enforcing the highest level of quality in products and services via

valid cGMP/GLP/ISO/ICH testing and evaluation .

Highlights

.

Regulatory and customer audit expertise; Supplier and contract

compliance; OOS Investigation/CAPA expertise; LEAN/Six Sigma expertise

to streamline laboratory operations; Managed product stability

program; Directly involved with Method Validations and Method Transfer

protocols per CFR/USP guidelines. Authored/Trained/Enforced/Reviewed

laboratory SOP's and WI's, raw material/intermediate, and final product

specifications, and Method/Process validations.

.

Maintained Departmental expense and capital budgets. Team Building to

enhance value to the business and engage laboratory employees.

Developed robust and effective training programs to produce valuable

laboratory staff. Managed >25 laboratory personnel @ 90% degreed

professionals with routine performance evaluations based on

predetermined performance metrics.

.

ISO/ cGMP / ICH Laboratory Compliance Management Implement and maintain

internal laboratory audit systems for cGMP/ICH/ISO compliance. Created

critical KPI's to track and improve analyst performance, sample

turnaround times, and instrument uptime/performance.

.

Equipment and Computer Experience to include IQ/OQ/PQ Validations,

troubleshooting, calibrations, and maintenance for all systems: HPLC,

GC, AA, ICP, UV-VIS, KF, TOC, MS, multi-detector/titrant

auto-titrators, densitometers, viscometers/rheometers, ISE pH meters,

NMR, DC-ARC, FT-IR. SAP/Microsoft Office/Sigma Xcel/Blue Mountain

Calibration and Maintenance Database/Empower/Chemstation/Honeywell

LIMS.

Experience

QA/QC Manager June 2011 to July 2013

Ceradyne Boron Products Quapaw, OK

Successfully managed all aspects of the Quality Department. Implemented

and maintained quality systems and internal audits programs.

Responsible for coordinating all regulatory/customer audits and

completing the audit process through corrective action verification.

Adjunct Professor January 2012 to May 2013

NEO A&M College Miami, OK

Provided instruction for students in Process Quality. Emphasis on

LEAN/Six Sigma techniques.

Corporate Quality Control Manager January 2005 to April 2011

ViJon St. Louis, MO

Responsible for cGMP/ICH compliant management of all QC testing

facilities. Managed all aspects of the microbiology and chemistry

testing laboratories. Directly involved in CAPA, method, and process

validations. Improved and maintained product stability testing program.

Quality Control Supervisor/Project August 2001 to December 2003

Manager/Radiation Safety Officer

Syncor West Chester, OH

Responsible for regulatory and customer audit activities in the cGMP

manufacture of P.E.T. radiopharmaceutical production. Created a highly

effective training program and trained all associates from 15 cyclotron

sites located throughout the U.S. Developed and validated an O18 water

recycling program that saved the company $300k/mo in operating cost.

Custom Synthesis Chemist August 1999 to August 2001

Isotec Miamisburg, OH

Responsible for production and pre-QC analysis of a wide array of

compounds possessing stable isotopic labelling patterns. Improved

several processes through innovative continuous improvement techniques.

Education

Bachelor of Science, Chemistry, Minor: Biology January 1998

University of Southern Colorado Pueblo

GPA: 3.6. Graduated with ACS Option

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