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Manager Quality

Location:
Roanoke, VA
Posted:
September 02, 2019

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Resume:

KEVIN E. FLIPPEN

*** ****** ******

Vinton, VA **179

Cell Phone: 540-***-**** E-mail: ***********@*****.***

CENTER QUALITY MANAGER

Twenty years of experience supervising and managing blood-derived manufacturing procedures, product and employees. I am highly effective in tracking and trending over multiple aspects to determine root cause, gap deficiencies, efficiency improvements, and waste reduction. I am a designated trainer for Quality Unit personnel, a mentor in this field, and referenced by many colleagues.

Center Quality Manager 1997-Present

Talecris Plasma Resources, Roanoke, VA

An affiliate of Grifols, Inc.

Supervise processes and employees to insure safety, potency, purity and quality of the product that is sent throughout the United States and overseas.

During my tenure at this location I have been promoted multiple times. My job title order is: Plasma Processor, EH&S Coordinator, Quality Assurance, Quality Supervisor, QS Lead, and Quality Manager. During this time the facility has been bought and sold eight times, changed standard operating procedures 7 times, and changed between digital and manual processes four times.

Corporate Validation Representative during a company-wide upgrade of plasmapheresis equipment.

Maintain all FDA, OSHA, iQPP, European, CLIA and Customer regulations allowing the product to be sold at the highest rate.

Perform internal assessments providing information for improving the quality of the product as well as the increasing the efficiency.

Records review, including recognizing and preventing a gap in testing procedure, thereby stopping the loss of thousands of dollars at the center.

Tracked and trended deviations within the system allowing for a more detailed root cause analysis to be determined. This decreased the number of deviations by up to 47%.

Established CAPAs and reviewed the effectiveness of the CAPAs that significantly decreased the amount of product lost.

Formulated training of cGMP for the associates that decreased the number of errors by up to 52% overall and 90% in specific individuals.

Writing Standard Operating Procedures and performing training with all areas/levels of employees.

Create KPI standards and spreadsheets to manage the standards through out the Company.

Performed numerous trainings on continuous improvements in sterile techniques to prevent potential cross-contamination.

Multiple presentations on procedure implementation and KPI tracking for quality and regional managers. Lead in many research/presentation development projects, in collaboration with teams from diverse job backgrounds.

Frequently served as a reference point on procedures/processes for peers and corporate representatives.

Enjoyed improving quality culture through motivating my own team and other quality units throughout the company, through verbal support and creative incentives.

Cultivated a healthy team atmosphere by facilitating conflict resolution and mediation.

Scheduling, including approving time cards, to ensure most efficient use of man hours.

Production Personnel 1994 - 1998

JOHN C. NORDT CO. INC., Roanoke, VA

Responsible for testing and producing material sold worldwide.

Operated multiple types of equipment allowing for increased efficiency and decreased employee downtime.

Verified all specifications of manufactured product were met, which allowed me to accomplish the highest yield within the company.

Trained new associates to effectively use the equipment so that they increase their yield.

Inspected the cleaning of machines during inventory, which decreased the amount of loss.

Proprietor 1991 - 1994

KEVIN FLIPPEN CONTRACTING, Roanoke VA

Through customer relations, the business increased by 50% via word of mouth.

Payroll and bookkeeping allowed for an 80% profit.

Performed equipment maintenance; kept the overhead at less than 10%.

Supervised employees, which lead to 0 injuries throughout the company’s life.

Kennel Assistant 1990

VINTON VETERINARY HOSPITAL, Vinton, VA

Assisted with the retrieval of test samples, autopsies, minor surgeries, large animal examinations, medicating, and other associated tasks.

Care and keeping of the animals and oversight of the hospital’s closing.

Education B.S., Life Sciences, Major in Biology, concentrated in microbiology and immunology, minor in chemistry, VPI 1997

Training EH&S training, DuPont Safety training, Haemonetics PCS2 maintenance and repair training, PCMS/DCS equipment installation and validation documentation training, and gap analysis.

Certificates Certified Quality Improvement Associate (ASQ)

References upon request.



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