Manager Quality

JAMES “ALAN” OVERTON, JR., ASQ-CCT

**** ***** **** ******, ***** Carolina 27896

252-***-**** * *************@*****.*** * www.linkedin.com/pub/j-alan-overton-jr-asq-cct/4/641/341/

OBJECTIVE

Longevity via a full-time position with an quality driven, established, financially stable, and ethical organization where principles

resonate through culture and values are shared. One where employees are appreciated for their contributions and that seeks to improve

the quality of life for their employees and their families.

EXPERIENCE – QUICK REFERENCE

Auditing * Budgeting / Procurement * Calibration Programs * CAPAs * Commissioning * FDA Regulations * ISO Standards *

Client Satisfaction * Procedures * cGMPs and GLPs * Quality Management Systems * Regulatory Compliance * Root Cause

Analysis * Safety Programs * Spare Parts Inventories * Traceability * Training Programs * Trend Analysis * Troubleshooting *

Validation Protocols * Vendor Management

QUALIFICATIONS SUMMARY

Multi-talented quality and metrology manager with experience in developing quality management systems and associated quality system

procedures, authoring procedures and forms, performing audits, nonconformance issues, environmental monitoring, distribution of

quality documents, recalls, training, trend analysis, regulatory compliance, qualifying vendors, corrective / preventive actions, client

satisfaction surveys, etc. Currently preparing for the ASQ-CQT (Certified Quality Technician) Certification.

Additional experience in diverse measurement parameters of metrology (chemical dimensional, electrical, mechanical, thermodynamic,

and time and frequency), possessing a thorough knowledge of the principles of measurement science, technical analysis of measurement

problems, accuracy, and precision. Strong knowledge of commissioning and validation practices associated with the biotech and

pharmaceutical industries, including: automation, facility, clean room, laboratory, manufacturing, packaging, process, production,

stability, R&D, and utility systems and equipment. Proven success with the core values of client (end user of instrument) relationship

management and vendor interaction.

Well versed with common industry standards, such as ISO/IEC 17025 – General Requirements for Testing and Calibration Laboratories,

21 CFR, Part 210/211 – FDA Code of Federal Regulations (CFR) concerning Good Manufacturing Practices (GMPs), and Good

Laboratory Practices (GLPs), and Quality System Regulations (Title 21).

Developed a strong set of ethical ground rules that persist in my work habits and in considering the best way to fulfill my

obligations.

PROFESSIONAL EXPERIENCE

Applied Calibration Services, LLC (c/o Pharma Matrix, LLC) – Wilson, NC (Resigned to seek new opportunity) Nov 2011 to Mar

2014

Manager of Quality / Deputy Manager of Technical Operations (Trainer & Safety Officer)

Instrumental in establishing a Metrology Laboratory from initial conception through the ISO/IEC 17025 Accreditation Process (in less

than 11 months with minimal findings). Authored an ISO/IEC 17025 Compliant Quality Manual and associated Quality System

Procedures, and other applicable procedures (auditing, calibration, maintenance, operation, safety, training, etc.) and forms. Specified and

procured the necessary NIST Traceable Reference (Measurement) Standards and Reference Material Standards to conduct laboratory and

field calibrations for parameters such as: Chemical, Dimensional, Electrical, Mechanical, Thermodynamics, and Time / Frequency.

Performed internal audits, liaison for external audits, conducted recalls, generated calibration due notices, maintained corrective /

preventive actions, addressed client complaints.

Developed training program (technicians must read / comprehend procedure, perform procedure, and demonstrate competency

before conducting calibrations).

Additional responsibilities included, but were not limited to: document control, facility / vehicle maintenance, human resources,

marketing, proposal / quote generation, sales, shipping / receiving, and website design.

Pharma Matrix, Inc. – Wilson, NC (Start-up Applied Calibration Services) Oct 2011 to Nov 2011

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JAMES “ALAN” OVERTON, JR., ASQ-CCT

2400 Surry Road Wilson, North Carolina 27896

252-***-**** * *************@*****.*** * www.linkedin.com/pub/j-alan-overton-jr-asq-cct/4/641/341/

Senior Validation Specialist (Pfizer Animal Health, Charles City, IA)

Executed Installation, Operational, and Performance Qualification Protocols for Incubators and a -70 Degree C Walk-In Freezer.

KBI Biopharma, Inc. – Durham, NC (Offered partnership in start-up of full service calibration company) Oct 2010 to Feb 2011

Metrology Supervisor

Supervised in the effective and efficient operations of the organization’s Metrology Program.

Brought HPLC System preventive maintenance and calibrations in-house at a significant annual cost savings ($80K+).

Monitored calibration technician’s daily activities.

Carefully selected qualified vendors to perform the necessary maintenance and calibrations on-site.

Managed inventory of over 1,200 pieces of analytical and manufacturing systems, equipment, instrumentation, and devices.

Gilead Sciences, Inc. – Durham, NC (Organization closed Durham facility and relocated to Foster City, CA) 2004 to 2010

Senior Research Associate / Analytical Laboratory Metrologist

Facilitated the Analytical Metrology Program for the Bio-analytical Laboratory Operations Group of analytical laboratory

Instrumentation (balances, centrifuges, controlled storage units, HPLCs, pipettes, etc.). Maintained compliance by: Authoring SOPs,

performing preventive maintenance, maintaining spare parts inventories, executing IQ/OQ and PQs, initiating change requests, and

troubleshooting / repairs as necessary.

Participated in numerous internal (QA) and several external (FDA) audits without significant recordable findings.

Streamlined calibration processes for resulting in a substantial annual savings of $143K+ in manpower and reduction in

instrumentation downtime.

Implemented scanning of critical documentation into “*.pdf” format, leading to shortened review time, record accessibility,

100% reduction in the possibility of records being misplaced, and ease of record archiving.

Implemented and managed the preventive maintenance program for 30 controlled storage units (freezers, stability chambers,

and refrigerators), minimizing the need for vendor services and extending the life of each unit.

Instrumental in facilitating the repair of two failed HVAC Units, protecting large amounts of R&D samples.

Reduced quantity of surplus of pipettes being maintained and calibrated, leading to significant annual cost savings ($4k).

Incorporated centrifuges and glassware washer to in-house maintenance and calibration program, resulting in a cost savings

from costly vendor services.

Supervised the installation of the upgrades for the GE LabWatch Environmental (temperature / Humidity) Monitoring System.

Specified and procured a multi-channel thermal monitoring system that allowed the calibration verification of 2 to 3 controlled

storage units at one time, significantly reducing manpower requirements as well as calibration time.

Recipient of two (2) “Extra Values at Work” Awards and four (4) “Spot Recognition” Awards.

Integrated Project Services – Morrisville, NC (Laid off due to economic downturn) 2002 to 2004

Senior Commissioning / Validation Specialist (Cardinal Health, Raleigh, NC)

Generated and executed commissioning documents and validation protocols for utility systems:

Developed the format for 75% of all commissioning documents for client.

Generated and successfully executed the commissioning documents for client’s air compressors, air handling units, boilers,

chillers, etc.

ADDITIONAL EXPERIENCE – CONTRACT & TEMPORARY

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JAMES “ALAN” OVERTON, JR., ASQ-CCT

2400 Surry Road Wilson, North Carolina 27896

252-***-**** * *************@*****.*** * www.linkedin.com/pub/j-alan-overton-jr-asq-cct/4/641/341/

Manpower Technical (various clients) – Calibration Specialist, Year 2000 Compliance Specialist 1998 to 2002

Synerfac (various clients) – FDA Expert, Calibration Manager, Senior Validation Specialist 1995 to 1998

Day and Zimmerman - Life Sciences International (various clients) – Calibration Specialist, Validation Specialist 1992

to 1995

Johnson Controls (Glaxo, RTP) – Calibration Technician 1988 to 1992

MILITARY SERVICE

United States Navy – Pearl Harbor and Mediterranean (Honorably Discharged) 1984 to 1988

Instrumentman (Calibration Technician)

Assigned to the Mechanical Instrument Calibration and Repair Shop (MIRCS Lab) both on shore and sea duty commands. Performed

numerous calibrations such as pressure, temperature, tachometer, liquid-level, torque, flow, combustibles gas, dimensional, chemical and

repair of office machines and reproducing equipment.

Designed a multi-port manifold for calibrating eight (8) pressure (diver’s) gauges at one time, streamlining the calibration

process.

Recipient of the Armed Forces (Navy) Expeditionary Medal for Persian Gulf (Earnest Will) Operation.

EDUCATION & CERTIFICATIONS

Certified Calibration Technician, American Society of Quality (ASQ) 2013

Associate of Arts - Business Administration, Strayer University, Morrisville/Cary, NC 2007

Industrial Electronics Coursework, Wilson Technical Community College, Wilson, NC 1989

o Student Government Association Vice -President

Basic College Coursework, University of Hawaii, Manoa, HI 1985-1987

Instrumentman Class A School, United States Naval Education and Training Command, Great Lakes, IL 1984

Academic Diploma, E. T. Beddingfield High School, Wilson, NC

1983

SOFTWARE

Agilent/HP ChemStation Chromatography Software

Fluke Met/Cal Calibration Management Software

IndySoft Calibration Management Software

Prime Technologies ProCal V5 Calibration Asset Management Software (Administrator)

Shimadzu Chromatography Software

Windows Operating System and MS Office Suite

PROFESSIONAL MEMBERSHIPS

American Society of Quality (ASQ)

International Society of Pharmaceutical Engineers (ISPE)

The International Society of Automation (ISA)

COMMUNITY LEADERSHIP & INVOLVEMENT

Rolesville Parks and Recreation – Baseball Coach

Upward – Basketball Coach

Wilson County Youth Athletic Association – Baseball Coach

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JAMES “ALAN” OVERTON, JR., ASQ-CCT

2400 Surry Road Wilson, North Carolina 27896

252-***-**** * *************@*****.*** * www.linkedin.com/pub/j-alan-overton-jr-asq-cct/4/641/341/

Wilson Parks and Recreation – Baseball, Football, and Soccer Coach

Page 4 of 4

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