Manager Quality Assurance

DENISE A. PIRKO

**** ********* *****, ******, ** 43021

740-***-**** . *******@*****.*** . www.linkedin.com/in/denisepirko

SUMMARY

Senior level leader with extensive experience in Operations, Lean Six

Sigma, and Project Management in the food, nutritional, medical device, and

pharmaceutical industry. Versed in FDA Regulations 21 CRF 106, 107, 110,

111, and ISO Standards 17025 and 22000. A highly motivated professional

with demonstrated strengths in execution and delivery of business

strategies. Summary of qualifications include:

. Operations support to internal and external Third Party Manufacturers

(TPM's), suppliers, and customers. Focusing on global synergies and

standardization to gain maximum operational and organization efficiencies.

Extensive knowledge of manufacturing operations.

. Six Sigma Certified Green Belt in lean methodologies and tools including

Kaizen, DMAIC, Root Cause Analysis, FMEA, Swim Lanes, Process Mapping,

Voice of Customer, Survey Monkey, 5 Why's and Fishbone.

. Project Management proficiency with leading large size cross-functional

projects including business entrance and exit strategies, implementation

of new systems and processes, project timelines, and execution.

. Crisis Management team member leading and managing internal and external

crisis events. Provide liaison guidance between cross-functional areas to

determine magnitude and impact. Responsible for contingency planning to

minimize sales impact. Well versed in the collection and generation of FDA

recall documentation.

. Quality expertise in all facets of quality, compliance, and regulatory

oversight including internal and external gap analysis, audit readiness,

program and policy development, CAPA, KPI's, management review, and food

safety.

PROFESSIONAL EXPERIENCE

Assurance Consulting Limited, Inc., Columbus, OH Jan, 2013 to Oct, 2013

Providing Quality Assurance, Regulatory, and Compliance consulting expertise

to new start-up manufacturing liquid and dry blend premixes facility.

Defining, constructing, and implementing FDA quality systems elements,

manufacturing programs, HACCP, GFSI Standards, and on-site analytical

testing laboratory capabilities.

. Company has a global presence in the food, beverage, and nutritional

industry. Initiating facility, program, and quality system improvements

to meet compliance requirements to expand business portfolio in include

infant formula, dietary supplement, and pharmaceutical industry

customers.

Abbott Laboratories, Columbus, OH 1994 to 2013

SENIOR MANAGER, THIRD PARTY MANUFACTURING QA OPERATIONS (2011 - 2013)

Managed and directed the manufacturing and quality of nutritionals, dietary

supplements, pediatric accessories, consumer products, and kit/displays

produced by 31 global TPM's for Abbott Nutrition. Provided day-to-day

operational support to assure quality while driving gross margin

improvement and brand category expansion. Managed a product batch release

staff that was responsible for the review and release of over 5500 TPM

batches annually. Administered and oversee compliance for the CAPA and

complaint programs for TPM manufactured products.

. Defined and implemented Quality System program requirements at TPM's

including TPM qualifications, periodic assessments, and audit readiness.

Monitored TPM KPI's through monthly metric and management review forums.

Executed focused projects to drive improvements in performance and reduce

nonconformances with potential to impact supply chain availability.

. Reduced TPM nonconformances and opened corrective actions by 24% within

first six months of assuming the role.

. Improved monthly reporting of TPM's metrics performance by focusing on

number of batches produced, product formulation, and nonconformance

trends.

. Developed a comprehensive program for the assessment, qualification and

maintenance of TPM's which provides a consistent method for the

management of TPM's.

MANAGER, GLOBAL QUALITY OPERATION (2007 - 2011)

Provided project management and business expertise to 8 Abbott Nutrition

global manufacturing plants on quality and operation supply chain issues.

Championed Division and plant compliance and process improvement projects.

Performed "crisis management" of deliverables during business critical

issues. Oversaw documentation and corrective actions/preventive actions in

preparation for FDA regulatory review.

. Conducted assessments of quality systems and programs against external

and internal regulatory requirements. Recommended enhancements and

prioritization to bring gaps into compliance. Worked directly with site

management to develop, execute, and provide overall organization

awareness of new systems and process.

. Defined and rolled out a comprehensive Pest Control Program to fifteen AN

global manufacturing sites within nine months post a business recall

event. SME presenter of the event at the 2011 Global CAPA Symposium with

attendees from all Abbott Divisions.

. Received the 2009 Q Award Program for efforts in response to the 2008

China melamine contamination global event. Assumed project management

leadership for the development of the global testing strategy and

execution. Completed the testing of over 573 different product families

within five months of the media event.

. Created cross functional teams to work through supply chain and

compliance concerns to minimize risk to business and customers.

PLANT QUALITY ASSURANCE MANAGER, RESEARCH & DEVELOPMENT (2008)

Oversaw the compliance of research, sensory, and clinical products

manufactured in a pilot research facility. Supported strategic quality

system development including CAPA, Quality Key Performance Indicators, and

audit readiness.

. Championed cross functional process improvements to the North America

clinical manufacturing process including the integration of products into

a CAMBAR inventory system to enhanced control and traceability of

products. Worked with team to clarify roles and responsibilities within

clinical manufacturing processes.

. Developed and led the exit strategy for a $30 MM operation that stored

and shipped clinical products, direct to consumer purchases, and

promotional materials to internal and external customers. Worked with

internal functional areas to outsource these specialized business support

functions to other parts of the organization or to TPM's.

MANAGER, HEALTHY LIVING QUALITY OPERATIONS (2005 - 2007)

Responsible for product formulation development and manufacture of

nutritional bars at three facilities; two third party manufacturing plants

and one Abbott plant. Collaborated with all three sites to standardize

processes, formulations, and aesthetic characteristics to maximize customer

preference.

. Created and implemented new conventional food processes and business

models such as complaint handling, surveillance testing programs, and

product change control.

. Established company wide recognition of "conventional food standards"

independent of regulated infant formula and medical foods. Creation and

acceptance of "conventional food standards" expedited speed to market of

innovative new products and assured profitability to business unit.

. Recognized with 2006 President' Award for recognition of contributions to

Abbott All Employee Survey team.

. Received the 2005 Chairman's Award for establishment of conventional food

standards for Abbott Nutrition.

PLANT QUALITY ASSURANCE MANAGER, MEDICAL DEVICES (2004 - 2005)

Answerable for GMP compliance, manufacturing quality, complaint handling,

and quality planning for two device manufacturing facilities and a

complaint call center. Accountable for the compliance of CAPA projects,

the disposition non-conforming materials and the continuous improvement of

products and processes. Managed a department staff of 35 management,

exempt and hourly employees focused on maximizing efficiency and company

investment.

MANAGER, QUALITY OPERATIONS (2003 - 2004)

Team member dedicated to the development and integration of RFID (Radio

Frequency Identification) technology into the nutritional manufacturing

facilities. Involved in the assessment of various RFID hardware, software,

and tag capabilities.

MANAGER, CORPORATE QUALITY AND REGULATORY (2001 - 2003)

Worked with the divisions, strategizing and outlining project timelines to

address key quality and regulatory issues. Standardized "Best Practices"

within Abbott to enhance quality. Liaison between corporate and

nutritional divisions to promote consistency in quality and regulatory

activities.

. Developed the corporate nutrition newsletter and website to communicate

quality and regulatory issues with potential to impact the business.

Monitored information from domestic and international regulatory

agencies, scientific and industry groups, and trade associations.

. Served as the SME to the divisions on key nutritional issues such as

allergens, labeling, food security, and global documentation.

PROFESSIONAL DEVELOPMENT

Bachelor of Science-Food Science and Nutrition, The Ohio State University,

Columbus, OH

. Certified Green Belt - Lean Six Sigma, Business Excellence

. HACCP Certified to HACCP International Alliance Accreditation

. CAPA Certified in Investigation Tools and Investigation Writing

VOLUNTEERISM

Supporter and member of the Olentangy Athletic Boosters focused on

fundraising and community support of team sports.

Through a partnership with The Ohio State College of Engineering, provided

business and education volunteerism for the 2011 First Lego League through

the Gahanna Middle School Robotics Club.

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