ELIZABETH A. McREYNOLDS

**** ***** ******** ****, ***. 151

Greenville, SC 29615

864-***-****

Please consider this letter and accompanying resume as an application for employment with your organization.

I am applying for the Quality Management position.

I have a Bachelor of Science Degree and over 20 years of experience in associated Quality areas. I have worked

as a Chemist, Microbiologist, ISO Lead Auditor and Quality Manager.

I have been responsible for regulatory and customer audits and have managed various Quality system

programs, including SOP and Validation programs. I am well versed in quality regulations, such as CFR part

210, 211, 111, and ISO 9000 requirements.

My accomplishments include:

• Direct contact and procuring a 50 million dollar account

• Streamlined Product Batch Records by reducing redundant documentation

• Instituted a FIFO system for PBR review reducing product release time

• Placed Auditor in packaging facility which resulted in faster product ship time. Better customer

satisfaction, and eliminated the cost and need for couriers from manufacturing to packaging facility.

• Streamlined the Calibration program from 3 separate vendors to one vendor resulting in a cost savings

• Project Manager for Master Control database. A single base for all critical documentation for quicker

access and review

I would appreciate the opportunity, at your convenience, to discuss my qualifications for the position of Quality

Manager.

Best Regards,

Elizabeth A. McReynolds

Enclosure

Elizabeth A. McReynolds

1421 Roper Mountain Road, Apt. 151

Greenville SC 29615

864-***-****

PROFILE: A responsible, dependable, self-motivated individual who works beyond the job

description: organized, thorough, and detail-oriented.

STRENGTHS: Bachelor of Science degree in Biology with experience in testing in nutraceuticals,

medical device industries; proficient in analyzing needs and

development/implementing programs and procedures.

Implemented various programs such as: Standard Operating Procedures, Internal Audits, Customer

Complaints, Pest Control, Calibrations, and Purified Water System.

• Initiated the Validation and Environmental testing programs.

• Facilitated Supplier Qualification program.

Skilled with spectrophotometers, (flame atomic absorption, FTIR, UV-VIS), ICP, liquid

chromatograpy, Solaris, computer literate in Microsoft Office (Word, Excel, Power

Point).

EMPLOYMENT HISTORY:

20014 to Present PALMETTO HARDWOOD SERVICES, Simpsonville, SC

Administrative Assistant/Accounting

• Customer Service

• Complaints

• Data Entry

• Receipts

1993-2013 GENERAL NUTRITION COROPRATION, Greenville, SC

2000-2013 Quality Programs and Compliance Manager

• Managed a staff of 10 employees.

• Responsible for audit and release of all manufactured product lot batch

records.

• Responsible for review and authorization of all batch record Certificates of

Analysis.

• Responsible for review/revision review, maintenance, and final authorization

of all Standard Operating Procedures (SOPs) for two facilities.

• Responsible for review, investigations and responses for all customer

complaints, and final close-out of complaints.

• Responsible for all internal audits for two facilities. This including

scheduling, performance, and final close-out for both system and

hygiene/housekeeping audits.

• Responsible for scheduling and document review of pest control processes for

the facility.

• Responsible for review of Purified Water System documentation, changes,

and final reports.

• Responsible for and facilitated/assisted in all external (Customer, Halal,

Kosher and Regulatory) audits.

• Responsible for data base that contained facility deviations, customer

complaints, and critical change processes.

• Facilitated the preparation and delivery of performance reviews.

• Developed departmental budget and managed costs.

• Worked closely with manufacturing to ensure compliance with customer

requirements, quality polices, company and regulatory standards.

1997-2000 Lead Chemist

• Managed a staff of 4 Chemist. Ensured that critical items were addressed

and processed as soon as possible.

1995-1997 Chemist

• Performed assay testing on vitamins/minerals utilizing various

instrumentation.

1993-1995 Microbiologist

• Performed microbiological testing on raw materials and finished product.

1985-2000 BAUSCH & LOMB, Greenville, SC

1996-2000 Lead Auditor

• Performed all internal and external audits. Facilitated regulatory audits.

Compiled quarterly management review of all KOM’s for Greenville facility

for B&L Corporate Management. These documents were used in regulatory

audits as well.

1990-1996 Microbiologist

• Performed microbiological testing on finished products (plating and

microbial identification).

1985-1990 Chemist

• Performed testing on raw materials and finished products utilizing various

instrumentation.

EDUCATION:

BACHELOR OF SCIENCE degree, BIOLOGY

BOB JONES UNIVERSITY, Greenville, SC

SELECTED CAREER DEVELOPMENT TRAINING:

ISO-9000 Lead Auditor – ANSI-RAB Certification

Six Sigma Green Belt

Contact this candidate