Quality Assurance Manager

Summary of Qualifications

Noted for streamlining procedures to improve productivity and efficiency.

Skilled at identifying and resolving microbial contamination issues,

supervision, auditing, implementing cost saving strategies, and improving

customer relations. Committed to continuing professional development and

sharing knowledge with staff.

Areas of Expertise:

Staff Training & Supervision ( Product Testing ( FDA Compliance ( ISO ( GMP

(

Troubleshooting ( Audits ( Document Implementation/Revision (

Deviation/Nonconformance/CAPA Investigation

Professional Employment

STERIGENICS, Smyrna, GA Sept. 2009 - Present

A FDA regulated facility that provides contract sterilization (EO, Gamma &

E-Beam) services for the medical device, pharmaceutical and food industries

(www.sterigenics.com). Sterigenics has approximately 400 employees

worldwide with revenues of up to $68 million annually.

( Quality Assurance Manager

Coordinate all activities relevant to FDA, ISO, customer and other

regulatory audits. Coordinate activities relating to determining and

reporting causes of nonconformances/deviations as well as implementing

corrective actions and process improvements. Maintain quality records and

procedure manuals. Coordinate and maintain personal dosimetry records.

Coordinate with plant Operations all system requalification activities.

Review and release batch records for processed materials. Establish

departmental objectives to meet overall facility goals. Provide quality

training to plant employees.

IMMUCOR, Norcross, GA Jul. 2006 - Sept. 2009

A FDA regulated facility that manufactures automated analyzers and reagents

used by blood banks, hospital, and clinical laboratories to test blood

prior to transfusions (www.immucor.com). Immucor has approximately 600

employees worldwide with revenues of up to $240 million annually.

( Biological Quality Assurance Manager

Manage and provide guidance to staff responsible for product testing, OOS

testing, complaint investigation, environmental monitoring, media fill

observations and special projects. Develop and maintain department budget

and quarterly metrics. Provide microbiological support/feedback for the

validation of equipment and clean room qualification. Interact and

provide data to the FDA during annual inspections. Interact with and/or

provide assistance to production departments to help ensure that critical

plant systems (water systems, autoclaves, controlled processing areas)

are maintained.

. Streamlined/revised customer complaint testing process, reducing turn-

around time from 60 days to 20 days or less, improving customer

satisfaction.

. Highly instrumental in the development and implementation of a new

environmental monitoring program which improved the ability to

monitor, identify and correct unfavorable trends in controlled areas.

. Implemented FDA approved test methodology used to assay red cell

product line.

TYCO HEALTHCARE, St. Louis, MO Jan. 2005 - Feb. 2006

A FDA regulated facility that manufactures radio-pharmaceuticals for

diagnostic use in hospitals and labs worldwide (www.tycohealthcare.com).

Tyco has about 246,000 employees worldwide with revenues of up to $12

billion annually.

( Product Assurance Supervisor

Manage 11 technicians responsible for sterility/endotoxin/biological

performance testing and the validation of equipment. Provide guidance to

the environmental monitoring technicians who are responsible for WFI,

air, and compressed gas testing. Develop and audit systems to assure

proper operation of plant microbiological functions. Help develop new

processing capabilities and facilities, to reduce the likelihood of the

introduction of microbial contaminants into product. Provide

microbiological support for R&D product testing & validations (IQ/OQ/PQ

review). Interact with the FDA during inspections to answer technical

inspections and review test data. Interact with production and facility

conformance to insure that critical plant systems (WFI & other water

systems, autoclaves, aseptic processing areas) are properly validated and

in control.

LEE LABORATORIES, Grayson, GA / Subsidiary of BECTON DICKINSON Aug.

1999 - Jan. 2005

A FDA regulated facility that manufactures immunological reagents for

research applications and diagnostic use in hospitals and labs worldwide

(www.bd.com). Lee has about 40 employees with revenues of up to $3 million

annually. Parent company, BD, employs 28,000 worldwide with profits of up

to $8 billion annually.

( Quality Assurance Microbiologist

Maintain a viable culture collection and supply cultures to the

manufacturing department. Perform serological, environmental, OOS and

microbial testing. Conduct GMP & ISO 9001 internal audits. Assist manager

in OOS investigations. Responsible for managing the CAPA system.

Investigates, and implements corrective actions associated with customer

complaints and product failures. Work with specialists at the CDC on

product troubleshooting. Assist Facility Director in USDA site visits in

the absence of the QA/RA Manager. Review validation (IQ/OQ/PQ)

documentation for microbiological relevancy. Experienced in 5S(Lean

Manufacturing) & Six Sigma projects.

. Streamlined and revised customer complaint testing program,

drastically reducing turn around time from 152 days to 50 days or

less, improving customer retention.

. Highly instrumental in preparing company for ISO 9001:2000 re-

certification

. Highly instrumental assisting manger in streamlining, revising and

improving the preventive/corrective action system.

. Instrumental in the CE Marking of Lee Labs IVD product line

NATIONAL EGG PRODUCT COMPANY (now Rose Acre Farms), Social Circle, GA

Nov. 1997 - Aug. 1999

Produced dried and liquid egg products used in the food manufacturing

industry for Kellogg Co., Krispy Kreme, GM, The Pillsbury Co., Keebler Co.,

Nabisco, and many others.

( Quality Assurance Manager (Aug. 1998 - Aug. 1999)

Supervised 3 microbiology and chemistry lab technicians and assisted

staff with analytical tasks to meet deadlines. Contributed to development

of HACCP plan. Implemented programs to improve department efficiency.

Assumed additional department duties after plant layoff.

. Implemented a hand-sampling program that successfully isolated the

origin of a massive Salmonella contamination saving the company about

$50K a year in lost product.

. Conducted an air-sampling program that verified the presence of

environmental contaminants from outside tankers. Presented findings

and a proposal to remedy the problem to management and gained funding

to enclose the tanker bay.

( Quality Assurance Supervisor (Nov. 1997 - Aug. 1998)

Conducted daily GMP audits and assisted the technical director in various

research projects. Assisted in preparation of AIB and customer audits.

Promoted to Manager after 9 months.

SILLIKER LABORATORIES OF GEORGIA, Stone Mountain, GA Feb. 1996 - Nov.

97

A food testing and consulting organization with a worldwide network of

labs. Silliker offers microbiological and chemical testing, research and

educational services to the food industry globally.

( Operations Supervisor (Nov. 1996 - Nov. 1997)

Supervised and trained 6 to 8 lab technicians in the microbiology lab.

Specialized in culture growth and identification. Have experience with

the growth and maintenance of Listeria, E.coli, Shigella, Campylobacter,

& Salmonella. Implemented changes and training necessary for A2LA

certification. Coordinated project testing for clients seeking USDA

approval and crisis situations. Assisted manager in employee hiring,

performance appraisals, and work schedules. Promoted twice in less than

10 months.

. Instrumental in successful attempt to obtain A2LA certification,

giving the company increased global visibility and dramatically

increasing marketability resulting in projected sales increases of 25

to 30%.

. Resolved customer service problems stemming from a communications gap

between management and lab technicians by implementing daily meetings

to resolve these issues, resulting in significant gains in

productivity and efficiency.

( Senior Microbiology Technician (Oct. 1996 - Nov. 1996)

Performed QA and routine micro lab testing and supervised micro lab staff

in absence of operations supervisor. Promoted in less than 2 months at

position.

( Microbiology Assistant (Feb. 1996 - Oct. 1996)

Performed qualitative, quantitative, and diagnostic procedures as well as

on-site sampling for clients. Promoted after only 8 months.

Education Bachelor of Science in Biology

Savannah State University, Savannah, GA - 1995

Concentration in Microbiology; Minor in Chemistry

Extensive professional training information available upon request

Contact this candidate