Project Manager Management

Ann Panek

**** ******* *****, *********, ** ***** (c) 216-***-****

***.*****@*******.***

Primary Skills

Product/Project FDA/ISO Processes FMEA/HIPAA/Risk Analysis

Management

Quality Management Team Leadership & Change Management (ECR/ECO)

Development

FDA/CAP/CLIA/NY State Lean Principles & Auditor Knowledge Management/

Requirements & & Continuous Improvement Technical & Marketing

Compliance Training

Software Implementation Contract Negotiation PPAP processes

Career Experience

Predictive Biosciences Inc., (OncoDiagnostic Laboratory Inc.) Cleveland, OH

Aug 2010- June 2013

Associate Director of Quality Systems and Compliance Officer

Responsible for the operation of the laboratory in accordance with College

of American Pathology (CAP)/ CLIA/ NY state requirements, policies,

procedures, quality initiatives, lean processes, quality variances, and

continuous improvement..

. Revised and coordinated the Quality Assurance (QA) program including

trend analysis.

. Developed, implemented, and trained staff regarding quality policies,

quality systems to meet the laboratory goals and CAP / NY State

requirements.

. Audited processes for sustainability and to provide evidence of

compliance. Ensured all investigations were performed and closed in a

timely fashion. Monitor and report adverse events. Completed mock

inspections.

. Investigated all quality variance reports and compliance issues.

Monitored corrective and preventive actions plans.

. Lean improvements resulted in at least three times workflow capacity

without additional staffing, low capital investment, and no increase in

turnaround time.

. Successful CAP and NY State audits. NY approved the new laboratory for

Oncology - Molecular and Cellular Tumor Markers.

. Complied and submitted seven Laboratory Develop Tests for Assay Approval

in Oncology to NY state.

Consultant Dec 2006- Aug 2010

Providing management and consulting services to clients in the areas of:

lean, ISO, project and program management, kaizen, quality and process

engineering, quality management, performance metrics, continuous

performance improvement, Stage And Gate, innovation, ideation, problem

solving, training, knowledge management, new product development and

manufacturing.

Advantage Development Inc., Westlake, OH Aug 2009- Feb 2010

Knowledge Discovery Analyst

Responsible for knowledge discovery, process development, quality, and

architecture for a U.S. military contract.

MTD Products, Valley City, OH, Corporate 2006- 2008

Continuous Improvement Manager

Responsible for cross-business group program management that includes

leading, facilitating, budgeting, training, and auditing events to

increase process productivity, effectiveness, efficiency, and to improve

the quality of MTD's processes.

. Developed, implemented, and trained MTD's Whole Goods business on a new

product development process. The process compliance improved by at least

65%.

. Globally reduced downtime at plants by replicating a plant's production

line for pilot trials to identify and implement engineering changes prior

to production.

. Used Lean methodologies and tools including Values Stream Mapping, VM,

FMEA, 6S.

. Drove compliance as an internal auditor to ISO 9001:2001 and the MTD

Quality System regarding process, procedures, work instructions, and

forms.

. Integrated processes for finance, marketing, sales, engineering services,

engineering, and commercialization.

Ferro Corporation, Independence, OH, Posnick Center of Innovative

Technology 1998-2006

Technology Manager (2003- 2006)

Project Manager for the development, implementation, and management of a

web-based software (Accolade by Sopheon) to manage Ferro's $40 Million R&D

investment.

* Implemented a New Product Development process with Portfolio Management

that resulted in a 76% reduction of cumulative Stage and Gate Delays from

2002-2004. Improved process efficiencies by 30%.

* Responsible for design, evaluation, implementation, end-user training,

time scheduling/recording, and meeting milestones for the Accolade

software.

* Developed Risk Management tools/templates for Marketing, R&D, Legal, and

Environmental, Health, and Safety. Each group was responsible for

countermeasure plans.

* Developed processes to efficiently integrate, manage, and leverage

Ferro's Core Competencies and Core Technologies, budget and capital

planning, and R&D consolidation efforts, with metrics.

* Responsible for gaining and managing budgeting, creating requests for

bids, and managing detailed contract negotiation.

* Managed University Collaboration Agreements, include budgeting, managing

interactions, and facilitating of funding decisions.

Technician (1998-2002)

* Project lead for the investigation of nano-clay technology for improved

performance in polyolefins.

* Developed sonication technology processes for nano-clay and Ceria Oxide

Slurries.

* Developed expertise in X-Ray Diffraction and Quasi-Elastic Light

Scattering for nano-material suspensions.

* R&D projects included development of liquid color for rotational molding,

FDA tubing adhesive, thermal and UV curing of an in-line coating for

pultrusion, and scale-up of polybenzoxazine syntheses.

TruSeal Technologies, Beachwood, OH 1997-1998

Technician

* Responsible for product development of window adhesives and hot melts.

* Developed formulations for improved performance and life cycle.

Conductive Polymers Technology, Ravenna, OH 1996-1997

Technician

* Responsible for technical support of basic extrusion and conductive rail

cable.

* Started thermal analysis lab and performed data translation for process

and formulation improvements.

NASA/ Ohio Aerospace Institute, Brookpark, OH 1993-1995

Intern

* Responsible for cure cycle development of high temperature polymers,

polymer identification, analytical equipment, analysis, and

interpretation.

* Increased composites performance and lifecycle by reducing void content

to below 10%, via vacuum bagging for pre-preg systems.

* Co-authored several NASA HITEMP Publications in 1994 and 1995.

Education

Lean Enterprise Systems Design Institute, University of Tennessee, 2008

B. S., Business Management, University of Phoenix, Cleveland Campus, 2005.

GPA 4.0

1992-1999 Cleveland State University, Cleveland, Ohio. Chemical

Engineering Major/Chemistry Minor

Patents

. Primary inventor on "Impact Modified Polyolefin Compositions". EP1543060

and WO2004039146 (2005). Improved strength and stiffness while improving

cost efficiencies.

. Primary inventor on "Impact Modified Thermoplastic Olefin Compositions"

WO2004039149 (2005). Improved strength and stiffness while improving

cost efficiencies, specifically for the automotive industry.

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