Quality Manager

L Denese Wilson

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

Painesville OH 440**-***-*** 9660

Summary Of Qualifications

Experienced Quality Professional with dutiful respect for compliance in regulated environments with a clear

vision to accomplish stated company goals, supported by the following:

Cleaning Validation Lab Equipment Computer System

Validation Skills:

Validation Validation

Packaging Validation Process Validation Method Validation

Protocol development, execution, summary reports: IQ, OQ, PQ, DQ, FAT

Quality Assurance Supplier Quality Audits Change Management Internal Auditing

Principles:

FDA, ISO, ICH, MHRA, ANVISA, EMA, JP, BP, Health Canada, EPA, NSF,

PCPC/CTFA

GMP, GLP, GDP, SOP, QSP, SSOP, CAPA, HACCP, TQM, 5S, Kaizen, AQL, SPC

Computer Skills: MS Office: Access, Word EDMS:, Documentum QSM: Trackwise, LIMS

Excel, FrontPage, Visio, EtQ, SAP, QMIS

ERP: JD Edwards, AS400

Project, PowerPoint MFG/pro

Career History

June 2012 Present Bedford OH

Quality Systems Manager, Change Control

BVL of Boehringer Ingelheim, Manufacturer of sterile injectables / parenteral pharmaceuticals

Direct and oversee the Change Control Department and Document Control

Department

Manage the Re vamp Project for documentation of cleaning validations and

verifications

Appointed Project Lead for the Change Control Remediation Program to ensure

compliance with ICH, FDA and EMA guidelines

Appointed Project Lead for the Consent Decree Remediation Document Control

Workstream

Participate in Consent Decree tasks: Baseline Inspection audits, Baseline Supplier Audits

Selected to support the Consent Decree Remediation CAPA Workstream, Validation

Workstream and Microbiology Lab Controls Workstream

Uphold Consent Decree Remediation planning, execution, implementation and

sustainability for Quality Assurance and for Management Controls, Supplier Management

Controls

Chosen to represent the Quality Unit in the Site De Commissioning Work Plan

Responsible for site wide Documentation Archival Workstream for the De

L Denese Wilson, Page 1 of 6

L Denese Wilson

497 Cherrywood Lane *************@*****.***

Painesville OH 440**-***-*** 9660

Commissioning

Member of the Corporate De Commissioning Team to establish best practices and

standards

Nov 2011 – June 2012 Cincinnati OH

General Manager, Microbiology Laboratories

ATL, Contract Lab services provider to Global Manufacturer of medical devices, pharmaceuticals

Manage the development and implementation of compliance training programs as

per site, corporate and regulatory requirements

Oversee proper lab testing execution per corporate policy and Quality Systems

Procedures

Facilitate recruiting process and establish position requirements, candidate

requirements

Participate on Management Review Board, Change Control Board and CAPA

Review Board

Recommend and develop CAPA’s for all identified deviations from GLPs, SOPs,

QSPs, etc

Manage the overall laboratory testing operations for multiple facilities (5), including

weekly client reports, testing turnaround times, work scheduling and sample receipt

Participate as reviewer of validation and engineering documents for protocol

adherence

Nov 2009 – Aug 2011 Memphis TN

Technical / Quality Director

KIK Custom, Contract Manufacturer of surfactants, deodorants and topical pharmaceuticals

Oversee and approve Annual Product Reviews for OTC pharmaceuticals

Primary QA Person of Contact to host Regulatory Audits, Vendor Audits, Customer

Audits

Successfully represented the facility during an FDA inspection with no observations /

483’s

Institute and manage appropriate Quality Systems by way of internal self auditing, SOP

review, training program development and SOP / Work Instruction implementation

Responsible for approving Supplier Corrective Action Reports, Nonconforming Material

Reports, Deviations, SCARs, Investigations and CAPAs

Direct the Quality Systems Unit for 24 hour operational facility of 325 employees to

include:

Document Control Warehouse Audits Incoming QC Lab Finished Good Release

Packaging QA Testing Quality Audit Training Microbiology Lab Bulk Batch Release

Batch Record Issuance Validations Chemistry Lab Environmental Control

Technical Specifications GMP Training Supplier QA Audits Regulatory Compliance

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L Denese Wilson

497 Cherrywood Lane *************@*****.***

Painesville OH 440**-***-*** 9660

Mar 2006 – Nov 2009 Sanford NC

Microbiology Manager & Regulatory Compliance

Coty LLC., Manufacturer of cosmetics, antiperspirants, deodorants and topical pharmaceuticals

Selected, trained and motivated departmental staff employees for 3 areas

Ensured facility compliance with FDA, ISO, CTFA, EU & JP regulations

Implemented new Quality Systems to ensure proper quality standards for Document

Control, Validation of processes, Inspection of Test Equipment, Training and CAPA

Created the Validation Department to uphold the requirements as (DQ, IQ, OQ, PQ)

Instituted new Supplier Quality Management plan by developing a vendor

certification program for 3rd party contractors, raw material suppliers and component suppliers

Liaison with Purchasing Department for approved suppliers and on hold suppliers /

vendors

Created the Batch Record Control system to ensure reconciliation per FDA

requirements

Conducted bi annual GMP & hygiene training sessions for full facility employees

Participated in Material Review Boards and Annual Product Reviews and Process

Review Boards

Reviewed and approved Regulatory Documentation: Standard Operating

Procedures, General Testing Methods, Investigation Reports, Mfg Specifications, Policies,

Nonconformance reports, CAPA plans

Directed and trained microbiologists to perform: Microbial Limits, Preparatory

Testing, Preservatives Effectiveness, Microbial Monitoring of Water Systems, Air Sampling,

ATP and Environmental Monitoring

Dec 2003 – Mar 2006 Fort Mill SC

Validation Engineering Specialist

Leiner Health Products, Manufacturer of solid dosage pharma, nutraceuticals and food additives

Conducted in process compliance inspections and supplier quality audits for production

areas in SC, NC, IL, PA, NJ, CA

Supervised junior specialists and technicians on generation/execution of validation IQ, OQ,

PQ

Performed, created, and executed equipment validation, process validation, cleaning

validation, packaging validation, method validation and computer system validations

Updated and reviewed Validation Masterplans, sampling plans, and acceptance criteria

Validation department representative on the Quality Team, for the auditing for equipment

suppliers, development of CAPAs and disposition of quarantined product

Trained technicians and junior specialists in: calibrations, AQL sampling, and technical

writing

Performed plant wide GMP, HACCP & hygiene training sessions and compliance audits

Performed calibrations and validations for autoclaves, ATP meters, refrigerators,

incubators, waterbaths, fillers, labelers, tablet presses, blenders, fluid bed dryers, DI water

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L Denese Wilson

497 Cherrywood Lane *************@*****.***

Painesville OH 440**-***-*** 9660

systems

July 2002 Dec 2003 Fort Mill SC

Quality Control Microbiologist II

Leiner Health Products, Manufacturer of solid dosage pharma, nutraceuticals and food additives

Stream lined, revised and created SOPs and Methods for the adherence to USP and cGMP

Supervised and trained junior microbiologists and technicians in the areas of: Microbial

Monitoring of Deionized Water Systems, Microbial Limits Testing, Anti Microbial

Preservatives Effectiveness Testing, Environmental Monitoring, Preparatory Testing,

Bioburden Testing and Microbial Isolation

Appointed as the Quality Assurance Customer Complaints Coordinator

Supervised testing schemes for the validation of the Vitek system, Autoclaves & parts

washer

Performed Calibrations and Validations for sterilizers, incubators, freezers, refrigerators

Reviewed Environmental Monitoring, Pest Control procedures and sanitation

documentation

Performed Bio Burden testing, Friability, Dissolution, Disintegration, Hardness,

Thickness, titrations etc, as per BAM, FDA and USDA guidances

July 1998 – July 2002 Lincolnton NC

Quality Control Microbiologist II

Alpharma Pharmaceuticals Inc., Manufacturer of liquid, semisolid, gels and topical Rx pharmaceuticals

Updated and created training matrices, training diagrams and flowcharts for corporate use

Representative to perform quarterly Hygiene training sessions for production workers

Participated in validation studies for the Biolog system, autoclaves and refrigerators

Supervised and scheduled daily lab assignments for six employees to maximize efficiency

Certified Trainer for: Microbial Monitoring of Deionized Water Systems, Microbial

Limits Testing, Anti Microbial Preservatives Effectiveness Testing, Preparatory Testing,

Environmental Monitoring and Isolation/Cultivation of Microorganisms

Oct 1995 – July 1998 Microbiologist Inman SC

Spartanburg Analytical Services, Provider of contract laboratory testing services

Aseptically collected water samples and prepared samples for coliform and pathogens testing

Performed Environmental Monitoring Testing, classified and stored microbiological media

Responsible for maintaining precise records of the monthly Laboratory supplies

Prepared various testing media and operated autoclave for disposal of Laboratory wastes

Education

Clemson University Clemson SC

Bachelor of Science

December 1995

Microbiology

Keller Graduate School of Cleveland OH

Master of Business Administration

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L Denese Wilson

497 Cherrywood Lane *************@*****.***

Painesville OH 440**-***-*** 9660

DeVry University In progress

Healthcare

Affiliations / Certifications

Food Quality Safety Manager ServSafe Certified November 2005

Member

ASM, ASQ, ASC July 2000 – present

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L Denese Wilson

497 Cherrywood Lane *************@*****.***

Painesville OH 440**-***-*** 9660

L Denese Wilson, Page 6 of 6

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