Quality Control Manager

Charles R. Lopez, Jr.

**** ****** ***, **********, (IN) 46112

317-***-**** (c)

abm26e@r.postjobfree.com

Objective

A challenging management or technical position where my in-depth knowledge

of manufacturing, financial and inventory systems can broaden the base of

expertise in a progressive and dynamic organization

SUMMARY OF QUALIFICATIONS

25 Years Supervisory/Managerial Experience

29 Years Pharmaceutical Experience

29 Years of Audit and Non-Conformance Investigation Experience

Applied Lean Six Sigma Experience

Government Regulatory Compliance Experience

EDUCATION

Bachelor of Science, Zoology Graduated:

May 1977

Arizona State University Tempe,

AZ

EXPERIENCE

Manufacturing Supervisor/Materials Management Supervisor/Sr Materials Tech

May 1998 - August 2009

Enzon Pharmaceuticals, Inc. (formerly Elan Pharmaceuticals, Inc. and The

Liposome Company), Indianapolis, IN

. Staffed, trained and scheduled 3-12 hourly employees for 24

hour/5 day/week SVP pharmaceutical Production and Materials

Management activities

. Used Six Sigma/LEAN principles for improving various functions

of Pharmaceutical compounding, aseptic filling, inspection and

packaging operations

. Maintained optimum Just In Time (JIT) and Kanban inventory

levels for commercial product domestically and internationally

. Pro-active response to Key Performance Indicators (KPI's) to

ensure department corrective actions and improvements could be

identified and acted upon

. Validated the Materials Management Department was compliant with

Sarbanes Oxley, FDA, MHRA, ANVISA and German Authority

guidelines

. Facilitated financial audits performed by various independent

agencies including Control Solutions, KPMG and Amper, Politziner

& Mattia accounting firms for inventories up to $22 million

. Maintained product Quality using FDA, MHRA, ANVISA and German

Authority guidelines, which were incorporated in standard

operating procedures

. Executed Capital Asset receipt and disposition activities and

adhered to departmental budget guidelines

. Conducted technical report writing of product and operational

non-conformances to allow timely release and shipment of

clinical and commercial inventory

. Developed and enforced Environmental, Safety & Health Department

security procedures for transportation of HAZMAT, based on

Homeland Security guidelines

Q.C. Chemistry & Solution Compounding Supervisor/Lead Technician

October 1980 - May 1998

B. Braun Medical, Inc. (formerly McGaw Laboratories, Inc. and Kendall McGaw

Laboratories), Irvine, CA

. Staffed, trained and scheduled 7 salaried Non-Exempts and 20

hourly employees for 24 hour/7 day/week Work In Process chemical

testing lab for LVP pharmaceuticals

. Scheduled 17 compounding tanks that supported 10 product filling

lines

. Assembled MHRA/FDA audit corrective actions for 483 observations

. Tested and verified correct formulations, potency of solutions,

using wet chemistry, bioassay and HPLC assay methods

. Validated and maintained the Quality Control LIMS computer data

entry system

. Maintained and updated applicable product test result

specifications and operating procedures to ensure compliance

with MHRA/FDA cGMP guidelines

. Validated new Production/Quality Control processes (IQ, OQ and

PQ protocols), prior to new technology and equipment being used

in production applications. (Referencing ISPE and PDA guidelines

to establish current industry standards)

. Compiled periodic trending test data for the testing and

monitoring of the Water Treatment facility, which included 8

stills, 3 softeners, 6 carbon filters and six 10,000 to 30,000

liter WFI (Water for Injection) holding tanks

Circulation Manager January 1978 -

September 1980

Denver Dispatch Newspapers, Inc., Denver, CO

. Distributed weekly advertisement newspaper in the Metro Denver

area

. Recruited and staffed 300 carrier and 8 distribution manager

positions

PROFESSIONAL DEVELOPMENT

Certifications:

. Kepner-Tregoe Analysis Certification (2000)

. Millipore Filtration Certification (1992)

. Total Quality Management Certification (TQM) (1990-1991)

Computer/Technical Skills:

. Fully proficient with all consumer Microsoft products (Windows

XP/2000/Vista., Office, Visio)

. Quarterly and Annual cGMP Training/Internal Audit Preparation

(2009)

. OSHA/Hazmat Training (2008)

. IATA Regulation Training (2007)-for Dangerous Goods Shipments

via Air

. Certified Supervisor Training (1996)

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