Quality Process Improvement

Tony Marzuco

**** ****** ****** ***** *'Fallon, Mo 63366

Home: 636-***-**** Cell: 636-***-**** e-mail: ****.*******@*****.***

Summary

. A positive Quality and Compliance professional with broad technical

knowledge and a strong cGMP pharmaceutical manufacturing (biologics,

liquids, creams, tablets, capsule) skill set.

. A self-starter who is skilled in Auditing, Root Cause Analysis,

Corrective Actions, and Project Management who successfully manages

multiple cross-disciplinary projects in a fast paced environment while

driving continuous process improvement.

. An experienced technology trainer in a quality environment with a

strong understanding of Lean Manufacturing, Six Sigma, Regulatory

(cGMP, DEA, DOT, HACCP, and ISO) requirements, process/system

validation, and software lifecycle.

Professional Experience

Validant Consulting 06/2010 - Present

Quality Investigator Consultant at Apotex, Inc. (Toronto, ON)

Review and approve product complaint investigations for liquids/sterile

facility utilizing SAP system

Review, assess, and mitigate compliance risks for Microbiology Laboratory

Investigation Reports.

KV Pharmaceuticals - St. Louis, Missouri 09/2008 - 06/2010

Quality Assurance Investigations Manager (Promotion) (1/2009 - 06/2010)

Managed QA Investigation team and site Investigation, CAPA, and Planned

Deviations systems and provide oversight for investigations of significant

deviations to manufacturing processes (liquids, creams, tablets, and

capsules), microbiological and wet chemistry laboratory testing results

OOS, incoming raw material testing (supplier quality), validation

activities, product complaints, and system issues that maintained site

compliance with Regulatory requirements utilizing TrackWise system.

. Managed/coordinated large process improvement project for

Investigation, Planned Deviation, and CAPA processes; including

process mapping/flow-charting, prepping of materials, and documenting

processes in standard policy and procedures using DMAIC methodologies.

. Managed/coordinated large process improvement project for

Investigation, Planned Deviation, and CAPA processes; including

process mapping/flow-charting, prepping of materials, and documenting

processes in standard policy and procedures using DMAIC methodologies.

. Performed tracking, analyzing, and trending of process metrics;

control charts, Pareto charts, histograms, as applicable

. Chair/participate in routine and non-routine meetings with affected

multiple groups across the entire KV organization to communicate and

resolve system and potential quality issues tied to investigations

. Chair/participate in routine and non-routine meetings with affected

multiple groups across the entire KV organization to communicate and

resolve system and potential quality issues tied to investigations

. Assemble, review and approve scientific and technical reports in

support of investigations. Write final evaluations and summaries that

assess product quality impact consistent with KV and regulatory

standards

. TrackWise system validation; developed and revised user requirements,

developed and performed testing plan/scripts; addressed

testing/validation exceptions.

Quality Scientist (9/2008 - 1/2009)

Review, approve, and disposition clinical batch records. Perform

investigations of non-conformance, GMP and system issues that resolve raw

material, in-process, bulk product, and packaged drug product.

Express Scripts - St. Louis, Missouri 12/2004 -8/2008

Sr. Compliance Manager (Promotion & Transfer) (12/2005 -8/2008)

Created/Expanded/Revised Site Quality Systems (Discrepancy Management,

Document Management, Change Control, Quality Audits, and Validation) for

Call Center, Data Entry, Mail Room and Pharmacy. Manage site compliance

risks for Missouri Board of Pharmacy, Multiple State Distribution law,

Federal Regulatory agencies (FDA, DEA, and Dept. of Health & Human

Services), and client contractual obligations.

. Host client and regulatory agency audits and manage observation

response.

. Performed tracking, analyzing, and trending of process metrics;

control and Pareto charts

. Managed/coordinated large process improvement project for

Investigation, CAPA, and Change Control processes; including process

mapping/flow-charting, prepping of materials, and documenting

processes in standard policy and procedures using DMAIC methodologies.

IT Quality Analyst/Software Tester (12/2004 - 12/2005)

. Perform regression, unit and functional testing of in-house

process/inventory software application/ relational database utilizing

SQL.

. Create analytical test cases to ensure maintenance of cGMP compliance

and validated state.

. Log software issues into Mercury Test Director; ensure issues

addressed with development team.

. Review, revise, and reconcile site SOPs to maintain cGMP compliance.

. Create and conduct testing for AVAYA Call Flow telecom system

. Provided Quality input and oversight to site external cGMP audits

Mallinckrodt-Tyco Healthcare - St. Louis, Missouri 04/2004 - 12/2004

Quality Engineer

Manage site Deviation Investigation system and provide Quality oversight to

product disposition and investigations of significant deviations to

manufacturing processes, validation activities, product complaints, and

system issues that maintained site compliance with Regulatory requirements.

. Managed/coordinated large process improvement project for

Investigation, Planned Deviation, and CAPA processes; including

process mapping/flow-charting, prepping of materials, and documenting

processes in standard policy and procedures using DMAIC methodologies.

. Direct support and hosting of FDA site inspection and provided Quality

responses and reviewed Manufacturing responses to FDA 483 observations

. Performed tracking, analyzing, and trending of process metrics;

control charts, Pareto charts, histograms, as applicable

Wyeth BioPharma - St. Louis, Missouri 12/2002 - 04/2004

Quality Specialist II

Provided Quality oversight to 2nd/3rd Party Contract Manufacturers and to

the St. Louis site for drug product disposition and investigations of

significant deviations to manufacturing processes, validation, and system

issues. Evaluated proposed major changes for St. Louis site and 2nd/3rd

Party sites. Authored, revised, and reviewed SOPs and CBE-30 applications.

. Provided Quality oversight to site projects as a member of multiple

project teams: Shutdown integration, CFR Part 11 Compliance, Center

Of Excellence, and Voltec BAS team.

. Authored and managed Legacy Plan for transfer of QA disposition

functionalities allowing transfer of ReFacto Center of Excellence to

meet transition target dates.

. Provided Quality input and oversight to FDA 483 observations to

multiple sites.

. Implemented and facilitated daily production deviation team to assess

quality impact of process deviations, allowing earlier Quality input

and decreasing overall investigation time frame.

. Performed tracking and trending of process deviations and led root

cause analysis and corrective actions of observed trends. Performed

deviation event analysis for Annual Product Review.

. Create regression, unit and functional testing of in-house software

facility control application.

Genentech, Inc. - Vacaville, CA 1998 - 2002

Manufacturing Investigator (2001 - 2002) (Internal Promotion & Transfer)

Performed investigations of significant manufacturing deviations, GMP

issues, automated control, and system issues that resolved raw material, in-

process and bulk product, environmental, and system issues within defined

time lines to maintain site Regulatory compliance and production

requirements.

. Authored, assembled, reviewed and approved technical and scientific

reports in support of investigations that assessed product quality

impact.

. Managed multiple cross-disciplinary investigation/root cause analysis

teams. Led investigations to closure within defined time lines with a

high degree of success (90%+) that met production schedule/product

disposition time lines.

Manufacturing Technologist (1999 - 2001) (Internal Promotion)

Responsible for assessing, implementing and validating new

equipment/processes while maintaining cell culture production schedule and

Regulatory compliance requirements. Trained and mentored cell culture and

manufacturing services technicians

. Founding member and Team Leader of Facility Inspection Team.

Developed and Trained area audit/inspection teams. Led FIT teams

through multiple Regulatory Agency inspection with no Facility related

observations.

. Performed debug/shakedown on process equipment and performed

Validation tasks (IQ, CQ, OQ, PQ) for that equipment under GMP

requirements that met Venice project time lines.

Senior BioProcess Technician (1998 - 1999)

Performed and coordinated mammalian cell culture manufacturing experiments

in Pilot Plant for Process Development and Manufacturing Science groups in

support of product launch goals. Highly proficient in Aseptic, cell

culture, and analytical techniques, equipment and supporting technologies

(Fermentor automated control systems).

. Trained technicians in cell culture process and Aseptic technique for

department and selected as New Hire Training Program Designated

Trainer.

. Member of Compliance Audit team.

Celtrix Pharmaceuticals - Santa Clara, CA 1996 - 1998

Manufacturing Associate

Performed pilot plant scale cGMP manufacture and purification of two

protein intermediates and one final drug product.

. Authored, revised, and audited cGMP batch records. Managed flow of

batch records and tracked through database management. Member of

Compliance Audit team.

Education

Bachelor of Science, Major: Biology, Minor: Chemistry, Additional

Concentration: Education

University of Missouri - St. Louis, MO

Professional Organizations

American Society for Quality

Skills

Process Mapping/ Corrective/Preventive Failure Modes and

Flowcharting Actions Effects Analysis (FMEA)

Lean Kaizen Events Statistical Process Root Cause Analysis

Control

Control & Pareto Charting Design of Experiments Internal/External

Auditing

Gantt Charting Change Control Management Complaint Handling

Professional Development

Software Life Cycle Root Cause Analysis High Performance

Training Management

Lyophilization Technology CAPA Training Conflict Management

BioProfile and YSI cGMP Basics 1 - 4 Effective Communication

Analyzer

Microfluidizer Training Training Procedure Time Management

Writing

Millipore Filtration Train the Trainer FDA Complaint Handling

Training

Kepner Tregoe FMEA & DMAIC Training Lean Manufacturing - 5S

Investigations

Leading Change Coaching for Success Foundations of

Management

HIPAA Compliance Training Coaching for Improvement ASQ CQA Cert.

(in-process)

Computer Proficiencies

Microsoft Office Suite SQL, TOAD, HTML, & XML Mercury Test Director

(Access, Word, Excel, and Adobe - Macromedia Mercury Quality Center

PowerPoint) Microsoft Dreamweaver and Bugzilla

Project and Visio Fireworks 21 CFR Part 11

TrackWise, SAP, LIMS, Adobe Professional,

AS400 Photoshop and

Illustrator

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