Quality Assurance Customer Service

LAURA CIBULSKY

**** ******* ****. 484-***-****

Wyomissing, PA 19610 *****.********@*****.***

SUMMARY

A Quality Assurance / Compliance Manager with a Six Sigma Black Belt and

over 20 years of experience in cGMP manufacturing and Quality Assurance

roles.

PROFESSIONAL EXPERIENCE

Targeted Excellence, Inc. 2011-present

Lead Subject Matter Expert and Interim Controls on U.S. Site FDA Consent

Decree Remediation

. Mentor and reviewer for complaints, investigations, CAPAs, change

controls, validation protocols and reports. Mentoring of quality

assurance, laboratory and manufacturing operations in a GMP

environment.

. Development and implementation of company wide standards and local

procedures in alignment with ICH, FDA and EU guidances for Process,

Cleaning and Packaging Validation.

. Development and implementation of governance policies and procedures.

Tray-Pak corporation, Reading, PA 2010-2011

Director, Quality Assurance and Continuous Improvement

Implemented best business, quality and operational practices in plastic

tray, design and thermo-forming company servicing the food, consumer

healthcare and medical device markets.

. Implemented a corrective and preventative action program that

reduced material hold rate by 15%. Developed supplier quality

improvement program resulting in a reduced cost of incoming raw

materials.

. Developed Quality Organization and led company to achieve first

"zero non-conformances" ISO audit and improved food safety rating by

40 points achieving "Excellent" category.

. Implemented complaint, change control, and batch record review

systems.

Johnson and Johnson, Lititz, PA 2007- 2009

Manager, Process Excellence, Quality Systems and Lean Enterprise

Developed Six Sigma, Process Engineering and Lean programs in semi-solid,

liquid and solid dose consumer healthcare and pharmaceutical manufacturing

and packaging areas.

. Developed and implemented a cost improvement program totaling $2.7M

using a cross functional team including engineering, operations,

planning, finance and quality.

. Reduced staffing requirements by 15% and spending by over $300K in 6

months by supervising, training and mentoring operators in Six Sigma

/ Lean techniques.

. Facilitated four and participated in seven rapid improvement

(Kaizen) events that resulted in savings exceeding $500K.

Achievements of the Kaizen teams included but were not limited to:

. Extension of continuous campaign lengths (doubled)

. Rapid changeover and reduction in testing cycle times

. Taught Six Sigma and Lean classes and mentored green belt project

leaders.

LAURA CIBULSKY

Page 2

Pfizer, Inc. Lititz, PA 2001-2007

Manager, Quality Assurance (QA) (2006-2007)

Managed and reviewed stability, product release, auditing, complaints,

deviation handling, and global regulatory compliance personnel (30),

documentation, area goals, metrics, and budgets.

. Achieved FDA approval for the first Pfizer Process Analytical

Testing (PAT) in-process release of finished goods to market

reducing test release time from three days to one.

. Reduced open deviation investigations by 50% (lowest number achieved

in two years) using mistake proofing and facilitating cross

functional review of trend analyses.

. Reviewed Quality Assurance systems with the FDA annually as part of

consent decree audits for the site. Initiated corrective actions

and responded to the agency with action plans.

Manager, Quality Control (QC) (2004-2005)

Managed microbiology, chemistry and receiving inspection laboratories and

personnel (70), area goals, metrics and budgets. Responsibility for on-

site analytical and micro method development.

. Reduced testing times by 25% by developing and implementing

laboratory scheduling and statistical process control (SPC) programs

for instrument maintenance.

. Reduced staffing in the QA and QC groups by 20% and improved test

cycle time by seven days by applying operations management to

laboratory environments, specifically process improvement and cross

training across departments.

. Reviewed Quality Control systems with the FDA annually as part of

consent decree audits for the site. Initiated corrective actions

and responded to the agency with action plans.

Senior Validation Specialist (2001-2003)

. Developed and executed protocols and authored reports in support of

equipment and utility commissioning and qualification, cleaning,

process, and packaging validation.

Warner-Lambert Company Lititz, PA 1996-2001

Senior Validation Specialist (1998-2001)

Production Leader (1996-1998)

Supervised three shifts of union personnel operating batch and continuous

automated processes.

JRh Biosciences Denver, PA 1992-1996

Technical Applications Engineer

Provided technical support and customer service to large scale

biotechnology and laboratory cell culture markets. Traveled with sales to

provide technical support to customers.

EDUCATION

. Master of Business Administration: Eastern University

. Bachelor of Science (Chemical Engineering): The Johns Hopkins

University

TRAINING AND DEVELOPMENT

. Six Sigma Black Belt : ASQ Lean / TPS Training:

Johnson and Johnson

. Leading Edge and Advanced Transitions Management Training Programs:

Pfizer

. Board Member, Wyomissing Public Library

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