1. Stephen Colletta –
Decisive Leadership for complex projects spanning 20 years: Pharmaceuticals, Medical Devices,
Biotechnology, validation qualification, Commissioning in support of Manufacturing, Product
Development; Process Development, QbD, QA, QE, Process Optimization , CPM, Six-sigma green
belt, GAMP5, 21CFR part 11; CFR : 58; 210; 211; 820 + ISO 9001, ISO13485, ICH Q8, Q9, Q10,
Q11
colt.bolt.quiver@gmail.com 470-226-6240 (mobile) 717-341-4499 (home office)
PROFESSIONAL SUMMARY
A history of leadership, accomplishment and innovation
1. 10 yrs. Environmental Health and Safety experience in the chemical and nuclear power chemical
operations fields and water effluent release regulations (NPDES).
2. FDA, EPA, OSHA experience spanning 5 years in new plant build approvals
3. Technical and Process control SME: A proven history of defining project, quality and regulatory
requirements, assign tasks and timelines, gain key stakeholder support for Manufacturing, IT and logistics
systems.
4. PHARMECAUTICAL DEVELOPMENT, DOE, PQ Testing, Scale-up from clinical trial formulations. New
product launches (8) in 5 years WITH 22 CAREER LAUNCHES
5. Experienced in Sales, Technical systems, facility/infrastructure, utilities, processes, control and monitoring
systems.
6. TECHNICAL TRANSFERS (7 drug products); New FDA/EPA/DEA approved R&D, Mfg. Facility (3)
approvals,16, Drug API cleaning validation approvals
7. Technical Validation and Regulatory compliance training for process, IT systems, and facility automation
8. Bird flu Vaccine Bio-Pharma DHHS Technical transfer (EU to SE USA) biological process specifications
and validation to ISO standards. Coordinate re-design QA acceptance specifications for mfg. and pkg.
containment / disposable designs.
9. CRM, Model –N, MES, LIMS, EM MFG. IT/IS systems FDA approvals
10. A career entailing R&D, PD, Mfg., Validation technical support for successful FDA approvals of 22
prescription drug platforms
11. Technical and regulatory (FDA, MHRA, EMA, CA, EPA, DEA, NRC, NPDES) project management
accomplishments as defined herein:
● PHARMACEUTICAL MFG. New Product DEVELOPMENT and Launch, 11 PAI QA acceptance approvals
followed by three new GMP drug R&D Mfg and packaging facilities approvals (FDA, DEA, EPA)

2. o Hired as the QA manager for an expanding pharmaceutical co to strategically design then tactically
implement as Tech Dir. For QMS, HSE, New Product Launch, New facility Commissioning, new mfg, pkg.
R&D equipment purchases (25 million $$$)qualification and validation FDA acceptance and acquired
Pharma co. tech transfer.
o Successfully launched 4 new cardiac product lines in 3 years, of controlled release pharmaceutical cardiac
drugs.
o Corporate revenue escalated form 1.2 million to over 300 million and stock price went from 10 per share to
over 300 per share before two 2:1 stock splits in 18 months.
● Hired as QA manager to Intervene in an ongoing pharmaceutical drug recall CAPA investigation because new
self initiated audit findings for Root Cause analysis were contrary to original findings in response to FDA
warning mandate of 29 lots.
o Devised implemented and managed the recall remediation preventing the recall by leading a team of
Quality Engineers QC, R&D, and biostatistics staff to successfully complete a five months study entailing,
demonstration batches and new API supplier stability analysis proving statistically to the FDA that the
Warning claim of loss of process control was 100% incorrect. FDA rescinded warning letter recall and the
corporation saved 20 million via recall prevention. API manufacturer. Product mfg. changes were
not disclosed 3 yrs after initial API contract approvals. (Root Cause).
● Developed the Technical transfer ISO specifications for the 300,000,0000 dollar DHHS contract for
Bird flu vaccine manufacturing plant in the SE USA. Conducted Gap analysis of existing biological
vaccine manufacturing and packaging containment and supporting steam clean utilities. Designed
the 35 Vaccine trial run engineering Performance qualifications for DHHS committee review where
initial biological failures were put under a CAPA program to define the engineering design flaws in
both upstream (raw materials and components, maintenance procedures for aseptic change over,
and downstream biological separation tools leading to six consecutive successful vaccine
development runs at full scale.
PROFESSIONAL EXPERIENCE
A.R. Medicom Medical Device Manufacturing 2015 – to present
Quality and Regulatory Affairs Operations Manager reporting to company President
Responsible for all FDA regulated GMP QA / QC staff (9) focused on improving regulatory compliance and
improving production quality and output for a high volume 3 shift Medical Device Mfg. company. Current expansion
of manufacturing and qualification validation project planning, training and implementation.
STEP CO CPC LLC: President and Principal Management Consultant October 2008-November 2014
QA, Manufacturing, Product Development - Scale-up, Computer Validation (CRM, LIMS, SAP, Model-N, Fusion,
Cloud, COT, custom, ERES), Cleaning Validation, Process Validation, Warning Letter & Consent Decree GAP
Analysis, QMS, CAPA & Validation Remediation; Technical/Engineering projects (DFMEA, FMEA, Risk Mgmt.
Design, MES, Site and process commissioning, qualification, FAT, SAT, Change Control, HSE..
Notable Clientelle
HeartWare VAD heart pumps – Miami, FL 10/2014 – July 2015
QA Compliance SME Consultant; CAPA Team Leader for several projects

3. Performing comprehensive quality systems audits and problem root cause investigations for quality systems,
computerized systems and product management and control systems. Managed various CAPA teams (35
business, technical, engineering, supplier quality staff).
1. Product alert Field actions, patient new pump, replacement pump, and emergency field action Remediation team
lead to resolve failed software document control and procedural upgrades to ensure FDA regulatory compliance for
patient pump tracking.
HVAC, Utility Maintenance programs, contract product Scale-up through commercial validation, packaging and
manufacturing process failures, and customer complaints for Prescription, OTC & DEA products.
2. Internal Audit remediation to address Inventory and Lifecycle non-compliance findings entailing component
lifecycle (pilot, pre-prod and prod) change management system improvements, SOP revisions and reprint
requirements upgrades.
3. Enterprise 21 CFR part 11 and SoX system remediation and emergency server controls to prevent device
distribution data losses and in-process component lifecycle status level integration losses due to system backup
failures.
4. Device field level failure remediation to define root cause basis for broken mechanical components failing during
pump implant.
5. Field Action operations review CAPA lead to design and build a web based Field action notification system to
reduce Field action costs from 50k per annum using a 21 CFR part 11 compliant ERES notification system
replacing a paper FedEx system.
6. Pump outflow graft failure and FMEA analysis to define field notification improvements and engineering design
and surgical tool development requirements for the currently commercial pump.
7. Completed the Inventory classification control CAPA to re-define the requirements for non-ASL components used
to support device manufacturing testing and facility operations. The 500 item list of consumables required
redefinition to ensure compliance to new HSE and logistics controls to prevent lifecycle and manufacturing
discrepancies identified through several internal / external audits and as cited in the recent FDA warning letter.
Janssen Pharmaceuticals - Titusville NJ Recall Project Manager 01/2014
- 03/2014
Janssen Doribax Global Recall & Market Authorization Transfer, Doripenem antibiotic. Managed the global
divestiture and Market transfer to Takeda Pharmaceuticals. Managed the strategic planning for health authority
recall requirements, regulatory submittal requirements and the product distribution activities; ~40 countries (EU,
Latin America, South America, Africa, Southeast Asia and Russia. Completed the global plan and defined the
regulatory submittal requirements, Janssen and Takeda roles and responsibilities of worldwide.
Infosys @ AstraZeneca - Wilmington DE Quality, Compliance and Security Manager 11/2012 -
03/2013
Manage offshore test teams and domestic project managers (6) for QA Validation testing, protocol development
and execution review and approval of FDA, SoX and non-regulated data systems under the new integration of
services and decommissioning of obsolete hardware internationally. Successfully eliminated testing errors and
completed migration on time.
Johnson & Johnson - Lancaster, PA and Las Piedras, PR Validation Lead 05/2012 - 10/2012
Packaging Risk Management Program Development and Remediation plan based on comprehensive mfg., pkg
SOPs for two North American Manufacturing sites under FDA Consent Decree.
Johnson & Johnson - Morris Plains, NJ Validation Lead 10 /2012 - 01/2013
Technical Writer and Team Strategic Adviser for QC Lab Instrument Commissioning, Validation Master Plan, URS,
FRS, SDS, PQ Test Protocol and Trace Matrix Protocol author.

4. Novartis Pharmaceuticals, Lincoln NE , Facility, Process, Pkg Validation Lead 02/2012 – 05/2012
Performed a comprehensive engineering, QMS and mfg. pkg. process equip. and utility audit and creation of gap
assessments and new QA Risk Mgmt requirements.
Day and Zimmerman, Philadelphia PA Business Development Manager 04/2011 - 11/2011
● Responsible for building new 2nd and 3rd Tier FDA Clinical Development and Manufacturing clients for staff
support relationships focused on qualification and validation of GMP and GLP operations.
● Developed a new client services contract and teaming agreement with a 3rd tier Biopharmaceutical company in
Florida for TEN (10) million dollar BARDA DHHS advanced manufacturing flu vaccine high volume output facility
build.
Environmental Solutions, Phila. PA 10/2010 - 01/2011
● Engineering Systems SME
● Responsible for completing the commissioning package binders for the New GMP manufacturing facilities,
HVAC- HEPA, Compressed Air, Purified Water, BMS, systems.
Guidewire DeviceTechnologies, Salem NH (worked remotely) 03-04 2010
● QA CAPA, process operations variances
● Advisor to the QA VP on process control validation and procedural, calibration non compliance audit
findings. Responsible for the analysis and development of a remediation strategy to define response details
to an FDA Warning Letter citing process validation deficiencies.
Nugen Technologies Inc. DNA analysis Kits and Mfg. GMP QMS upgrade 01/2009 - 05/2009
● QA Mfg. Ops ISO 13485 Compliance SME
● Scope of work covered technical and QMS AUDITS OF R&D and Mfg. Operations, resulting in neely
implemented QS GAP analysis program and QA validation testing, emergency preparedness planning, SOP
and IOPW Protocol upgrades and revisions. Provide Validation services for R&D and Manufacturing
operations to convert the Quality system from ISO 13485 to an upgraded quality system to meet FDA cGMP
regulations.
● Novartis, Wilson NC Validation Remediation Consultant 08/2008 - 12/2008
● QA Manufacturing Process Control SME
● FDA Warning Letter remediation strategy to implemented QMS audit Discrepancies for six banned products,
entailed process validation discrepancies and 1000 unresolved CAPA Investigation Reports.
NNE Biopharma Consulting - Netherlands EU Sr. QA ISO, FDA design control SME 2006-2008
● QA lead EU OPS AUDITOR and MFG DESIGN Project Manager and QE Validation Lead for the DHHS
Pandemic Flu Vaccine Development and Advanced Mfg. Contract. Extensive Internal R&D, Validation and vaccine
manufacturing operations audits to verify CBER US compliance. Identified numerous supplier quality issues for
biological contamination risks.
● Netherlands QA Engineering Mfg and R&D VACCINE VALIDATION PROCEDURES with Gap analysis and
audit findings report for Mfg. of MDCK cell propagation and contamination controls, Packaging line syringe
packaging containment and validation program risk assessment and gap analysis.
● QA auditor of Netherlands validation and vaccine programs, process optimization adviser of 21 trial runs and
reporting to DHHS.
● QA Project leader and approver for CRM sales and marketing customer management system under 21 CFR
part 11 requirements. The Cedigem Fusion CRM project was cited by INFOWORLD e-magazine as a Top Ten
Best Deployment of 2007.

5. AlannAssociates CSC, Engineering Services: FT Staff Project Mgr.- Validation Compliance 2001 – 2006
1. CIMA Laboratories - Eden Prairie, MN QA Mfg. Commissioning QMS Auditor 08/2006 to 10/2006
Commissioning, Validation, Mfg. Facility SOP, IS operations and IOPV protocol auditing.
2. Roswell Cancer Institute, Buffalo NY System Implementation SME 05/2006 - 08/2006
Eclipses Operating System Software Go-live deployment and nursing staff problem resolution field agent.
3.GE Healthcare, Milwaukee WI, Validation Manager 07/2005 - 04/2006
Manufacturing Computer Automation projects at two US sites and one Mexican site via Mercury Suite upgrade to
meet FDA 21 CFR part 11 regulations. Selected for project work to support Manufacturing sites in WI and Utah as
validation process management remediation advisor.
4. Forrest Labs, Hauppauge NY, SAP Integration Test Engineer 05/2005 - 06/2005
SAP-R3, CRM Integration Testing design development deviation corrective actions.
5. Schering Plough, US,, Ireland, Germany, Canada QA Consent Decree Mgr. 10/2003 - 05/2005
 Program Execution Office QA Manager and QA Team Lead-Consent Decree and CFR part 11
 International Training Instructor (US, Canada, Puerto Rico, Ireland, Germany, Belgium)
 Manage Validation SDLC CSV remediation activities at 11 sites globally. Conduct external Quality audits for
Compliance to PMO specifications, standards and regulatory compliance.
 Responsible for technical and regulatory content of SDLC deliverables, SOPs and Packaged IT Solution Kits
per 21 CFR part 11 FDA cGMP requirements. Project Database System Administrator for over 3,000 cGMP
documents and 400 global users.
6. Regeneration Technologies – Gainesville, FL Validation Master Plan Writer 02/2002 – 05/2002
Prepare the New Facility Validation Master Plan, SOP review and modification, and Critical Utility IOQ protocols,
sterile systems Protocol Development.
7. Watson Pharmaceuticals - Miami FLAPR writer, CAPA Review SME 10/2001 - 11/2001
Technical transfer document preparation, gap analysis and Annual Product Review report creation, technical
analysis and reporting for all products and processes prior to Technical transfer.
ANDRX Pharmaceuticals - Ft. Lauderdale FL 1996 - 2001
FT Managerial Staff - Capital Projects Engineering: QA Technical Mgr.& PMO Dir.
• Responsible for the purchase of manufacturing and packaging equipment to support new facility builds for a
publicly traded start-up pharmaceutical company for QbD mfg. design and implementation: site construction for
three (3) new GMP facilities, commissioning, validation, new product launch.
• Managed all facility commissioning test teams for QC labs, critical utilities, manufacturing and packaging
operations for four (4) solvent based polymer formulations used in fluid bed coating to create oral controlled
release prescription drug products.
• Under the direction of Sr. executives exec. VP Ops, CEO, CFO), Steve designed and implemented multiple
quality, technical programs to successfully scale-up, validate and launch 4 new drug product lines covering
three (3) new GMP construction, manufacturing facilities
o Equipment Design specifications, equipment purchasing, equipment installation, qualification and validation of
numerous finished package configurations for commercial distribution.

6. o Responsible manager for critical utilities design specification compliance, via IOQ testing of 25 HVAC-HEPA
systems, three ISO-13485 plant Process air systems and the design, installation and qualification testing of five
(5) USP –Purified water Turnkey systems.
o Creator of the Corporate Safety, Change Control, process, computerized systems Validation and cleaning
validation programs. Managed all qualification and validation projects over 3.5 years.
o Created the GMP QA operational SOPs and subsequently trained QA, QC, Mfg., Pkg., Maintenance,
Engineering and R&D staff in the use of pilot scale, manufacturing, packaging equipment.
o Awarded a $500,000 bonus after 4 years of accomplishments including FDA approval of three new cGMP
Mfg/Pkg. facilities, cleaning validation for 15 APIs, 4 new controlled release drug product lines, bringing in an
additional 300 million in commercial drug revenues (a 360% increase in 3.5 years).
o Most responsible site QA technical lead for FDA audits, Pre-approval Inspections, and Post Validation
Inspections.
IVAX Pharmaceuticals – Miami, FL 1994 - 1996
FT Staff QA Operations Manager: Mfg./Pkg. New Product Launch
✓ Managed the customer complaints investigation response to an FDA Warning Letter providing statistical proof
in 5 months, resulting in the FDA immediately rescinding the Warning letter and product recall which saved the
corporation ~ 20 million dollars.
✓ QA site FDA representative for all QA GCP, GLP and GMP operations, managing approved drug product
technical transfers (US to Ireland), domestic and Canadian product release and Packaging operations insert /
outsert, labeling approvals. In 12 months Steve Lead the quality engineering team to validate and gain FDA
approval of three NDA/ANDA drug products.
✓ Responsible for CAPA implementations, APR development and Customer Complaints Investigations, one
which lead to an API supplier problem discovery.
✓ QA Compliance Leader and team director for Product Customer Complaints (CAPA Development),
Process/Lab Failure analysis and technical/deviations, and QC-OOS Investigation reporting, Annual Product
Reviews, supplier quality investigations. Steve directed the operations for the R&D scale-up validation team
activities to receive FDA approval of three (3) ANDA and one NDA commercial drug product approvals in 12
months.
✓ Project Manager for Facility renovation and expansion entailing Commissioning, qualification, validation of
HVAC, ISO-Process air, purified water systems, and packaging line process capability expansion.
✓ Due to Steve’s accomplishments launching 3 new drugs product lines (2 ANDA, 1 NDA) Ivax’s revenues
increased in 1 year form 89 million to over 200 million.
R.W. Johnson Pharmaceutical Research Institute - Raritan NJ 1991 to 1994 Research Associate Scientist
• Responsible for the scale-up of powder formulations using Design of Experiments and six sigma methods. Duties
included process control data generation and statistical analysis, correlation and report writing to provide smooth
transition to full-scale production.
• Responsible for troubleshooting process control problems, recommending changes to processing and formulations and
providing documentation to support changes to equipment, process controls and raw material grade or supply source.
• Provided Quality Engineering validation support to the UK to Switzerland Technical Transfer and Validation project for
seven (7) oral contraceptive drugs.

7. EDUCATION & TRAINING: BS Biology (medicines) Widener University Main Campus
Series 7 and 63 SEC licensing 2.5 years US National Account Executive Training
Lasiter Root Cause Analysis for CAPA and Process Improvement, MiniTab DOE 2014
DuPont Six Sigma SPC Training greenbelt Certification 1993
Good Documentation Practices, Good Clinical Practices, Good Engineering Practices
Project Management Certification with 7 yrs applied PMO, PEO Pharmaceutical Operations
Computer Validation 21 CFR part11, SOX, Security, Audit Trail, Cloud, COTs, Custom, .Net
DHHS Advanced Mfg.; Vaccines H5N1 Mfg. site design criteria FDA, EMA, ISO, ICH
Health, Safety, Environmental , VEPCO Nuclear Power, North Anna Nuclear Units 1&2
Packaging Validation, Computer Validation, Process validation (drug solids, OTC liquids,
Vaccines)
W. Edwards Deming – Management Training: Manufacturing DMAIC SPC and Project Mgmt.
VEPCO Nuclear NRC STEP Program: Hazardous Materials, HSE, NPDES, EPA and Fire