Manager Project

Stephen M. Colletta Marietta GA ***** mobile 404-***-****

abhwsx@r.postjobfree.com

Bachelor of Science Degree - Biological Sciences

Graduate of WIDENER UNIVERSITY, Chester, PA

Mfg. industry leader, subject matter expert (SME) with over 20 years

Experience in disciplines including, but not limited to, Chemical analysis,

Dept. management, Union/non-union staff development, product development,

scale-up, validation testing, new product launch, new facility launch,

process improvement (six Sigma / DOE) and regulatory remediation (FDA, DEA,

EPA, OSHA).

Mr. Colletta is reliable, dependable, dedicated and creative technical QA

Manager, project team deployment expert with a long term history of

successful accomplishments in the Pharmaceutical and Nuclear Power

Industries'. He provides the leadership and impetus for creative and

innovative improvements in process workflow efficiency, production /

packaging output, waste elimination, complex problem solving (statistical

methods) and proactive elimination of regulatory intervention.

Mr. Colletta's premier leadership expertise provides operations vision and

team development that will ensure successful outcomes under most every

scenario. Stephen routinely employs efficient, focused project strategy and

innovative QA Validation compliance methods that have a proven record of

success as demonstrated by numerous successful accomplishments in:

Pharmaceutical / Medical Device Product Development and scale-up,

High Volume consumer product manufacturing output, process improvement,

waste reduction, supplier quality risk control, procedure review, revision

and retraining to improve operational profits and reduce cost and loss of

time.

Practical tactical management of complex international projects involving

complex, technical, regulated processes.

Leading Industry QA Compliance Expert.

The leading industry Expert and innovative strategist in validation

planning, and deployment at single multiple and international sites.

Validation expert in Plant commissioning under FDA cGMP standards and

regulations

Validation expert in Information Systems project management to ensure a

complete, efficient and effective go-live outcome. (EMS, BMS, LIMS, CRM

solutions).

Expert in new facility launch, new equipment purchase, install and

verification testing.

Over fifteen years of staff training (engineers, operators, packagers, QA,

QC, AR&D) in manufacturing process improvement, process validation,

cleaning validation, solving complex problems, effective team skills,

project management, FDA compliance, EPA compliance, OSHA compliance,

protocol creation, execution and reporting, Good Documentation and SDLC

practices.

QA Document Control design and maintenance, SDLC methodologies, CAPA, QA

Investigations Supplier quality and Software developer audits.

My current expertise allows me to provide my employer a focused, real

time, proactive quality assurance and control approach strategy that builds

disciplined teams. "Through the use of proven, creative, innovative, yet

cost effective QA/QC scientific method and validation tactics I will:

...definitely improve your product and work flow quality

...train your staff and markedly reduce human error, improve individual /

team capabiliies

...optimize your R&D to Commercialization process associated,IS/IT

practices, resulting in a optimized manufacturing and packaging operation.

... improve you business unit output, reduce and eliminate Non-Value-added

activities, eliminate waste, and build sustainable growth in your operating

profits".

S. Colletta 404-***-****

PROFESSIONAL EXPERIENCE

EnterpriseOne Solutions 404-***-**** 2008 to

Present

As Owner-Operator I provide sales, risk assessment, technical, regulatory,

validation and quality support to the Pharmaceutical, Medical Device, Bio-

Tech, Consumer products, Insurance and Financial Services industries.

Client: Dendreon, New GA clinical facility pre-FDA commissioning,

reporting, problem resolution. Contract ends Jan 2011.

Client: Primerica - Supporting the April 2010 IPO and regional Atlanta

Metro- market expansion through recruiting and team deployment management.

A former Licensed and Bonded stock broker working NYC and Phila. Markets

garnering over 3 million in assets under my control in 18 months (1989) and

current licensed Life, Accident and Health Insurance agent in GA.

Client; Guidewire Medical Devices: FDA validation remediation analysis Jan-

Feb 2010

Client: Senior Healthcare Consultants- Field Manager Medicare Healthcare

Insurance Prodicts

Client - Novartis Pharmaceuticals: Aug '08: I provided preliminary QA

Compliance Manufacturing and Validation process evaluations as well as

internal review of numerous CAPA issues and incomplete investigation

reporting. Project ended as planned in Nov 2008.

Client - Nugen Technologies Inc: Provided Validation Support to the QA, R&D

and Operations Depts.

in validation of biological storage equipment, and lab instruments.

Developed QS changes designed to meet ISO 13485 regulations in order for

the company to be prepared to meet FDA cGMP regulations.

Client - EMS: Examine expansion management process design through Field

Mkt. surveys.

S. Colletta 404-***-****

Solvay Pharmaceuticals Inc. 2006 to 2008

QA Validation Engineer / Quality Operations (resigned iAug '08 in advance

of pending DHHS Contract cancellation and subsequent sale of the company)

QA Project oversight responsibilities for a team of IT managers,

programmers and consultants in the successful completion of the customized

CRM system by Sedigem-Dendrite. The Fusion project was a successful 15

million dollar deployment considered by INFOWORLD as one of the Top Ten

Deployments of 2007- 2008. QA Project manager for the Model N design,

development, data systems conversion and integration. Responsible for

directing and approving project controls, design methodology staff training

and execution documents.

SOLVAY:: International Technical Transfer QA Engineer for the 300 million

dollar Department of Health and Human Services -Pandemic Flu Manufacturing

Facility Project until is cancellation by Solvay in Q3 of 2008. Project

"Panda " Contract handling establishment of validation standards for Flu

Vaccine technical Transfer from the Netherlands to the US. Accomplishments

include GAP analysis of MDCK vaccine production and containment packaging

lines for EU and US FDA requirements.

Computer Sciences Corporation (Consulting division) 2003 to 2006

Industry QA Validation Analyst and Compliance Manager

(Resigned in Oct '06 to take Sr. position with Solvay for special DHHS 300

million dollar contract)

Client - Schering Plough Pharmaceuticals, Cranford NJ 2003 - 2005 PEO QA

Manager and training manager.

Program Execution Office: Quality Assurance Manager and International

Training Instructor for the 500 million dollar FDA/Justice Dept. Consent

Decree.

Supervise a staff of 15 local IT & QA professionals and 5 off site teams to

develop solutions for eleven (11) sites globally in consent decree legacy

remediation of over 2,000 IT /Quality, MFG. and Lab systems.

PEO Database system Administrator for over 3,000 cGMP documents and over

400 global users

Classroom Instructor of 75 consultants worldwide for CSV remediation

methodology and 21 CFR part 11 / GMP, validation methodology training

Client: Forrest Labs SAP CRM Integration system testing design and

development April - May 2005

Client: GE Healthcare: Validation manager for Manufacturing Computer

Automation at 3sites June 2005 - March 2006

Client: SIMA Laboratories, Minneapolis MN QA Validation Manager

June -Aug 2006

.

S. Colletta 404-***-****

AlannAssociates Consultants, Fort Lauderdale, FL 2001 - 2003

Validation Project Director / New Business Development

Pharmaceutical and Medical Device Projects - Lab & Manufacturing Validation

including Process / Pkg. Equipment Filling Lines, Label Vision Systems,

RO/DI, Ultra-filtration water purification and Automated Environmental

Monitoring Systems (Invensys-Pritchett).Lyophilizers and LIMS remediation.

Resigned to find more continuous project work

Andrx Pharmaceuticals - Fort Lauderdale, FL 1996-2001

Capital Projects Director for Corporate QA Validation Compliance / Manager

QA Validation

Highly visible, independent management position with multiple project

responsibilities requiring weekly strategic and deployment meetings with

the Corporate President, CFO, and Vice Presidents (RA, QA, AR&D, Mfg) .

Responsible for planning, resource allocation, budgeting, and directing

Start-up, Scale up, commissioning and Validation deployment activities

Author of the Corporate Safety Policy

Author of the Change Control Policy and Procedures

Creator and Author of the Corporate Cleaning Validation Program, policies

and procedures.

Validation projects director for critical utility and Environmental

Systems, process equipment (pilot, mfg) to meet the aggressive launch

schedule of four new ANDA product launches.

Successfully validated all areas in three manufacturing facilities governed

by FDA cGMP, DEA and EPA regulations from pre-PAI to post market approval.

Directed all SPC continuous improvement Initiatives successfully utilizing

Six Sigma, LEAN and other process improvement methodologies resulting in

substantial reduction in waste, and marked improvement in manufacturing

cycle time.

Project leader for the AR&D/ QC lab expansion and transfer from leased

Facility 1 to the new company owned corporate HQ. Supported and validated

new stability chamber suite, (REES system) and four stand alone chambers.

Project management responsibility for all validation projects coordination

of AR&D, QC, Engineering, Maintenance, Operations and outside consultants

including HEPA-DOP testing, cGMP room ?P, HVAC facility balance testing,

viable & non-viable particle count testing, CA system particle count tests,

NRTL certifications for UL compliance, EPA solvent tank-farm certification

testing.

Andrx Capital Projects Engineering QA Compliance Director: Selected

Accomplishments:

Product Development and Launch

Diltia XR and Cardia CD extended release dosage form development from Scale-

up through packaging and post marketed process improvements.

Validation Projects - Led new construction cGMP compliance activities for a

$25 million, controlled release facility and the new $6 million, immediate

release facility design and renovation project. Managed budgets and work

for 2 consulting firms (35 contractors).

R&D Scale-up: Metformin, Ketoprofin, Buprofin, and Aspire Labs development

products

Pending Astra Zeneca Patent Infringement Suit loss resulted in Lay-off of

the entire Capital Projects Dept.

S. Colletta 404-***-****

IVAX Pharmaceuticals- Miami FL 1994- 1996

Supervised and developed direct reports in validation methodologies and

manufacturing problem solving and regulatory analysis for immediate and

extended release (ANDA / NDA) products. Responsible for the coordination

and performance qualification of Clinical batches for packaging. Compliance

Lead for Product Customer Complaints (CAPA Development), Process/Lab

Failure analysis and Technical Investigation reporting.

Selected Accomplishments:

100% release of problem lots, preventing rejection and product recall.

33% Price reduction of API eliminating quality problems, backorders and

production failures.

FDA Approval of a second source supplier, and major changes in product

specifications.

Successful validation of three ANDA products and the first IVAX NDA

product.

FDA approval for Verapamil API particle size specification changes and

batch record changes, eliminating the need for film coating process dew

point control.

Directed and managed the successful validation and launch of the First IVAX

NDA drug Elmeron and four other successful product launches for ANDA

generic products increasing business unit revenues by 50%.

Responsible for all packaging document control, label design and approval,

package insert & outsert design and approval, vacuum test validation,

torque capper validation, slant count filler validation, shipper labeling

validation, process optimization and new equipment review and approval.

Manage and improve packaging shipping computerized systems and raw

materials data input cycle counts and quarantine/ release warehouse areas.

RWJPRI & Ortho-McNeil Pharmaceuticals- Raritan NJ 1991- 1994

Research Associate - PDTS: Product Development, scale-up work for blending,

high sheer granulating, milling, compression and aqueous film coating and

fluid bed systems using Design of Experiments methods and Process

Improvement projects.

Selected Accomplishments:

Process failure analysis of the Tolectin aqueous coating process using

Dria-cota. Identified problems and solutions for coating pan HVAC design

and electrical motor voltage and spraying system design deficiencies.

Proposed and implemented a 5 million dollar redesign of air handling

system, purchase and installation of a 60" Accela-Cota and Thomas

Engineering Designed spraying system to eliminate coating process failures.

Provided real time process parameter control, total digital component

design, equipment and process validation resulting in a 1 year payback of

project costs and more efficient process cycle time reducing labor for

batching by 15%. Eliminated coating failures (9 batches / year) due to

voltage spikes and non-integrated

Process controls. (Awarded a $2,200 pre-tax bonus in 1992).

Saturn Team Project, resulting in an on-time, under budget, technical

transfer and validation of six Oral Contraceptive processes from the UK to

Switzerland including process and new equipment validation of blenders

(Jacketed I-Bar and Std. V types) and tablet presses.

Resigned in '94 to take QA Tech services Validation Managers Job at Zenith

Goldline/Baker Norton.

Virginia Power: North Anna Nuclear Power Units 1&2 (Mineral, VA)

1982 - 1986

Chemistry Supervisor- Chemical Operations, Water Purification, Plant

Operations Chemical Maintenance, QC analysis, NUS emergency preparedness

air & liquids sampling system validation with full immediate NRC approval,

Elected to National Nuclear Chemistry Advisory Board 1985-1986.

Prior to accepting the Nuclear Power position, I was formally accepted as

an Officer candidate in the United States Naval Aviators Program having

passed all physical, mental, security, visual acuity and flight stress

tests. I declined for personal reasons related to my wife and children.

QC Chemist - Metallurgical Lab, Westinghouse Power Generation Systems

(Phila. PA) '78-'82

Mfg. Supervisor - Lehigh Valley Dairies (PA) Manage a staff of 20

bottle filling operators '76-'78

PROFESSIONAL DEVELOPMENT

Training

Six Sigma '93 Design of Experiments '92

FDA GMP, GLP regulatory requirements Project Management for

'86, '91, '93, '95. '96-'01 Remote/Offshore and Matrix systems

'03,'06

21 CFR part 11 and GAMP 4 Validation Packaging Validation Methods '94,

methodologies for Computerized '02

systems '98-'08

Process Validation Methods '91, '94, Technical Transfer Methodologies

'96-'03 '93, '98, '06

Equipment Qualification and Quality Systems Design and

Validation '91, '95, '98, '06, '08 Development '08

Sales and Marketing of financial Life, Accident and Health Insurance

products Series 7 and 63 Licenses product licenses (GA) '09

(38 States) '89, 08

NRC Chemical and Operations Control

Methods '82-'86

Recognition - Awards Andrx Pharmaceuticals New facility

PAI Quality Award 1997

Andrx Pharmaceuticals, Quality Award Andrx Pharmaceuticals Diltiazem

for FDA 483 Cleaning Validation Controlled release Process

Remediation/Approval Validation and Launch 1998

Andrx Pharmaceuticals Promotion to Andrx Pharmaceuticals Quality Award

QA Compliance Director- Capital - Orange Drive Facility Design and

Projects 1998 PAI Approval 2000

Johnson & Johnson Quality Johnson & Johnson Quality

Achievement Award 1992- Process Achievement Award 1994- Project

Improvements Saturn Oral Contraceptive Technical

Transfer from UK to Switzerland

Zenith Goldline Quality Award - Dean Witter Reynolds - New Accounts

Process Validation - Elmeron NDA and Assets Control Leader 1990,

Launch 1991

Rorer Pharmaceuticals Quality Award- Elected to the National NRC / NUS

Process Improvement 1987 Chemical Operations Safety Board

1985

Activities Schreiner Academy - 2009-2010

Science Fair judge grades 1-8

Member ISPE - 2000 - 2008 Member Society of Manufacturing

Engineers and Board Member 1986 -

1992

Widener University Board of Managers Widener University - Regional

1989 - 1996 Recruiting and Mentor Program 1994 -

1996

Widener University - Features Writer

for "The Dome" 1974 - 1976

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