Quality Assurance Manager

SHEILA L. CASH

P.O. Box *****, Charlotte, NC **220 - 336-***-**** (C) -

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

Summary

Dependable, hard-working individual with over 15 years' experience in

research and development with a major Fortune 500 consumer products company

and over 15 years auditing experience. Proven skills in Quality Assurance

and Quality Control in the following: lead internal and third-party

auditing, research and development, analyzing data and performing

biological and analytical testing. Proactive, results oriented

professional with strong business knowledge, excellent technical and

communication skills. Demonstrated leadership skills within a corporation

or community service organization performing multiple tasks independently

or as a member of a team.

Skills

? Current Good Manufacturing Practices (cGMP) ?

Accredited Lead Auditor Training

Audits and Global Food Safety Initiative (GFSI)

(reference to the Medical Device Industry),

Audits (i.e. Distribution, Non-Food Processing,

ANSI-RAB Accreditation Program

Packaging, Kitchen & Slaughter Processing Markets) ?

Professional Association for Compliance

? NEHA Hazardous Analysis Critical Control Point

Managers (PACMAN)-Import/Export

(HACCP) Manager Training

Compliance Certification Workshop

? Good Laboratory Practices (GLP) ? Good

Documentation Practices (GDP)

? Corrective and Preventive Action ?

Calibration of Standards

(CAPA) Management ? Calibration and

Validation of Equipment:

? Lab Equipment Maintenance: HPLC, GC, GC-TEA HPLC, GC, GC-

TEA, RFA

RFA, DSC/TGA ? Computer Skills:

Laboratory Information

? Coached, Mentored & Trained Company Personnel System

(LIMS) Word, Excel, Outlook,

Temps and Students PowerPoint

? Business Owner & Staff Manager

PROFESSIONAL EXPERIENCE

ROCHE CAROLINAS, INCORPORATED 10/2013 to Current

Quality Assurance Specialist (Contractor)

Florence, South Carolina

Quality Assurance Division: A strategic manufacturing facility that

provides comprehensive technical support and quality assurance oversight to

meet good business practices and requirements of applicable regulatory

agencies, supporting the manufacture of drug intermediates and active

pharmaceutical ingredients (API) for pre-clinical/clinical studies and

commercial use.

. Provide quality oversight on the manufacturing floor

. Partner with manufacturing operations to reduce deviations, strengthen

cGMPs, and expedite investigations

. Perform real-time review of batch records

. Work with site personnel to remediate concerns found during real-time

process review

. Identify and drives the closure of deviations (as necessary)

. Perform final batch record review for product release

. Perform quality audits, as requested

. Perform Fit for Use, Line Clearance, SIGMON, and Visual/Swab

Verifications

. Audit manufacturing equipment logbooks

. Review/Approve Manufacturing Documents and Validation Documents for

Regulatory Compliance

. Audit Batch History Records

. Manages day-to-day activities for CAPA Management

. Implement and maintain documentation for equipment abnormalities

. Ensure that products are manufactured in compliance with the

regulatory and in a GMP compliant manner

. Provide support for FDA/Regulatory Inspections as needed

. Provide support for regulatory filings as needed

. Provide guidance and coaching in the application of GMP and GDP

throughout Quality

. Complete customer complaint reviews and provide written report to

management in a timely fashion

Sheila L. Cash Page 2

ASI, INCORPORATED 06/2011 to Current

Food Safety Consultant/GMP & GFSI Auditor

St. Louis, Missouri

Quality Assurance Division: Conducts food safety related audits at food

manufacturing, distribution

packaging facilities and other related sites within the food supply chain

for general food safety and current

Good Manufacturing Practices (cGMP) and Global Food Safety Initiative

(GFSI) which involves 50-75%

travel. Provides guidance and serves as a matrix manager during third-party

audits for company

management teams.

Serve as matrix manager for customer based clients across their inter-

company/intra-company

departments providing information, knowledge and guidance for

compliance with industry

standards

Assure consistency and accuracy in all audits and audit reports

Evaluate each facility's current Good Manufacturing Practices (cGMPs),

sanitation, product

safety, food safety practices and management systems, Quality

Management System (QMS),

with HACCP knowledge as well as government (i.e. FDA, FSIS, USDA,

C-TPAT) and current ISO

regulations as required

Maintain confidentiality for all aspects of work and adhere to all

procedures established by company and its client

Maintain applicable professional development required for audit proficiency

STERICYCLE (formerly RQA, INCORPORATED) 04/2007 to 10/2010

Quality Assurance Auditor (Contractor)

Indianapolis, Indiana

Quality Assurance Division: Served as an auditor for the food, beverage,

personal care, consumer products, medical device and pharmaceutical

industries with criteria based on specific regulations for industry and

governmental (i.e. FDA, FSIS, etc.) standards.

. Performed audits for product withdrawal, product recall, product

retrieval, consumer complaint as well as effectiveness checks

. Completed medical device audits, programmed new device with patient

set parameters, recorded and forwarded patient's confidential

information to home office during the 2007 international recall

program for the C-PAP machine.

. Interfaced with hospital pharmacies during the Heparin Sodium Recall

0f 2007 by retrieving product, packaging product for shipment for

return to manufacturer per company guidelines.

SYGENTA CROP PROTECTION 01/2005 to 03/2005

Chemist (Contractor)

Greensboro, North Carolina

Technology and Projects Group: Analyzed seed formulated products utilizing

HPLC and GC methodology.

. Conducted assays to determine levels of insecticides, pesticides,

fungicides and product stability studies for product claims

substantiation

. Utilized Good Laboratory Practices (GLP), cGMPs and GDP Guidelines for

studies

R. J. REYNOLDS TOBACCO COMPANY 01/1996 to 09/2003

Winston-Salem, North Carolina

Chemist II

01/2002 to 09/2003

Applied Research and Reduced Risk Division: Investigated novel

combustion/filtration technologies for product development.

. Designed and conducted synthesis and characterization studies of novel

nanoparticle catalyst yielding reductions in carbon monoxide

. Assisted with establishing a combustion and filtration lab, which met

company objectives in developing new research technologies

. Researched and developed new technologies, which led to securing

patents for new inventions

. Prepared research and developed reports, which resulted in keeping

departmental employees up-to-date with the most recent research

findings

Sheila L. Cash Page 3

Chemist II

10/2001 to 01/2002

New Product Development Division: Developed and introduced new products,

which met consumer

needs.

. Managed and Coached Employees, Contract Employees and Students with

product development goals

. Developed product and evaluated changes for test-market introductions

. Coordinated pilot plant production and analytical testing of new

products

. Designed and conducted experiments on novel polymeric materials for

improved selective filtration of smoke constituents

. Designed and conducted experiments on combinations of adsorbent

materials for enhanced filter efficiency

Chemist I

01/1996 to

10/2001

Analytical Service Division: Developed and implemented analytical

techniques, which achieved company goals.

. Managed, Trained, Coached and Mentored Lab Techs, Contract Employees

and Students on laboratory methodologies

. Served as lead auditor for ISO Standards 17025 initiatives and

conducted quarterly audits

. Served as Code Blue Responder for medical emergencies and maintained

annual CPR certification

. Developed standard operating procedures for analytical testing related

to research methods and instrumentation, which improved quality

standards for departmental needs

. Prepared and conducted quarterly audits of ISO Standards Guide 25 to

maintain quality system

. Provided support for a variety of analytical methods in the analytical

services division laboratory

. Maintained calibration and quality control standards for a variety of

analytical instruments

. Served as technical expert for design, fabrication and analysis of

personal air quality monitoring device for a national study which

covered 16 cities (required 70% travel). Evaluated over 10,000 samples

for this study and maintained confidentiality of participants

. Transferred analytical methodology across R&D Divisions, including

training of personnel and validation of procedures improving

efficiency and productivity

CERTIFICATION/EDUCATION

Hazard Analysis Critical Control Point (HACCP) Training

National Environmental Health Association (NEHA), Denver, CO - 2013

Lead Internal Auditor Certification

SAI Global (formerly Excel Partnership), Independence, OH - 1999

Corporate Professional and Development Training Courses

R.J. Reynolds Tobacco Company and Community College

Bachelor of Science: Chemistry, graduated Cum Laude

North Carolina Agricultural and Technical State University, Greensboro, NC

CIVIC ACTIVITIES AND AWARDS

. Hospice & Palliative Care Volunteer - 2010 to 2012

. Moses Cone Hospital Volunteer - 2010

. RJR Project Tanglewood with Big Brothers/Big Sisters - 2003

. National Career Awareness Program for College Students - 2002 to

Current

. Crosby Scholars Senior Advisor Program - 2002 to 2003, 1998 to 20018

. Anson County Bearcat Scholarship Fund Establishment 2001

. United Way of Forsyth County Executive Loan Officer Program - 2000

. RJR 125th Award - 2000

. Fund Allocation Committee/Advisory Board for the Arc of Winston-Salem,

NC - 1998

. Atlanta Committee of the Olympic Games - Olympic Torch Relay - 1996

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