EDUCATION
Wiltshire University
BS in in Mechanical Engineering January 1998 – January 2002
Tabernacle Baptist College
Biblical Theology January 1988 - December 1991
Stat-A-Matrix Institute
ISO-9000 Certification , Certification as Lead Auditor 1994
PROFESSIONAL EXPERIENCE
Sanofi, FDA Group, Framingham, MA
CAPA Coach/Specialist October 2020 – Present
Remediate backlog of CAPAs generated by deviations within the facility manufacturing and processing steps. Performed investigations, Root Cause Analysis, Risk Management and final report. Addressed the process through team structure and environment reporting to the management daily progress and observations.
Tissue Tech, Thousand Oaks, CA
Quality Specialist September 2020 – October 2020
Performed an assessment of the clean room qualification and compliance via remote document review and interviews of the management personnel to determine the efficiency and capability of the clean roon to maintain during manufacturing operations.
HMP Brands, Florida
Quality Specialist August 2020 – September 2020
Reviewed lab and pilot facility via video and provided insight and guidance to improve the facility to meet FDA Regulations as they prepare to scale up for full scale production of the OTC creams and ointments.
ATARA, Thousand Oaks, CA
Compliance Auditor June 2020 – August 2020
Performed onsite audit of the facility compliance to FDA Regulations in manufacturing pharmaceutical/biotech products. Provided insight and guidance to the Atara Management in preparing for the PAI Audit scheduled for 2021 by the FDA to approve their manufacturing sight.
Military Service
South Carolina Army National Guard 2-263ADA
NCOIC/Sr. AMDWS Operator March 2020 – June 2020 2007
Mobilized in support of Homeland Defense against the affects of Covid 19 security and safety personnel while providing aid to the civilian population.
Paragon Medical/NN,Inc., Pierceton, IN. August 2019 – March 2020
Project Manager, EU MDR Compliance
Plant undergoing EU MDR compliance upgrade. Project Manager to provide business and regulatory affairs leadership for a highly complex project supporting the transition from the EU MDD to the EU MDR and other regulatory needs across different global business units. As a member of project team and under the Paragon organizational structure in cooperation of Sales, Procurement and Regulatory, my duties would include proper guidance and support to transmit the associated documentation for OEM and Contract Manufactured Products and processes from one facility to another through interstate transfer in support of the customers goals to be compliant to the new EU MDR regulation. Project Manager collaborate with cross functional stakeholders to drive to solutions/results in accordance with the project deadlines. This Project Manager will make commitments to businesses and manage stakeholder expectations about project deliverables during the program. Other activities include preparing or submitting documentation to authorities for medical device product submissions, assessing country impacts of regulatory changes and coordinating across business units with regulatory affairs leadership. This role will report to regulatory affairs leadership.This would mean planning with the customers to ensure proper documentation was identified and accurate prior to sending to the sites. Liaison between the customer and the facilities. Essential duties and responsibilities include accountable for core team performance, project schedule, Lead the team in defining project deliverables, provide clear direction on the project to meet expectations of customers and business stakeholders, interacts through project updates and reviews with all stakeholders ensuring effective ongoing communications across team, stakeholders ensuring to identify communicate the project risks, development of risk plan and risk response strategies anticipating potential conflict situations in preparation for a proactive solutions. Work with cross functional teams to organize work and drive anticipated results. Additionally guided the team through variant documentation and the Brexit regulatory change from the UK to the NL.
Zimmer, Inc., Warsaw, IN. October 2017 – August 2019
Senior QA/RA Compliance Auditor
- Perform auditor responsibilities to ensure the activity performed supports the remediation plan and product safety to the customer/end user. Review IC procedure as it compares to the revised SOP to incorporate the Interim Control (IC) procedure requirements going forward. Verify the effectiveness of the training of personnel and their utilization of the procedures.
Arthrex, Naples, FL February 2017 – October 2017
Senior Quality Engineer
- Perform Audit of the NCR process. Perform pre-audit inspection prior to a third party audit. Perform quality function for NPI, change control, process improvements and corrective actionssuch as; review and approval of Special Work (SW) Router Request, FCA/FCP, Design review, Print Review.
- Assigned to resolve and track NCR's initially and work with manufacturing to improve the quality of the process in order to reduce NCR's and repeated occurrences. Provided a significant reduction in open NCR's.
- Prepared IP Sheets and Ballooned DWG's in support of NPI and the associated ECO's. Provided technical support for process improvement in the management and execution of the NCR program and related CAPA's along with SCAR recommendations in support of Supplier Quality functions.
Zimmer, Warsaw, IN February 2017 – June 2017
Senior Quality Engineer
- Preparation and executions of the HHE process for Knees, transitioned into NPI for Persona revision knee development. Performing review and approval of Special Work (SW) Router Request, FCA/FCP, Design review, Print Review, Define and establish Inspection Methodology and selection of gaging device.
Smith’s Medical, Plymouth, MN November 2016 – February 2017
Senior Quality Engineer
- Establish the process and procedures for the Supplier Selection and Maintenance Process. Managed the personnel and project controls for review and resolution of SCARs.
Tecomet, IN June 2015 – November 2016
Project Manager
- As a member of project FOOT PRINT team and under the Tecomet organization of Sales and Procurement, my duties would include proper guidance and support to transfer the products and processes from one facility to another through interstate transfer.
- Included planning with the customers to ensure proper bank build was established from the sending site so that there was no gap in the product chain during the transfer and validation within the receiving site.
- The qualification of the facility, utilities, equipment and processes that were to be used for the manufacturing of Class I, II & III medical devices must be established prior to submission of First Articles to the customers.
- This activity included the planning and execution of decommissioning equipment and processes for relocation to include resolution and closure to CAPA issues identified during the process.
- Provided leadership and guidance in the development of TMV process, Commissioning, Validation and MVP document.
Lonza, Portsmouth, NH March – June 2015
Sr. Quality Engineering II
- Develop form based protocols to execute for biological production systems to include Ultra Filtration Skids, CIP Skids, Tank modifications, Agitator placements, WFI distribution piping systems. Executions include review and approval of ETOP and FAT punch list closures, system walk-downs using P&ID drawings and Ladder Logic Diagrams for panel emplacements to control the systems..
- Write summary and final reports for protocol closure
- Provide peer review for associates validations activity and report writing for the completed protocol
MonoSol Rx , Portage, IN November 2014 – March 2015
Facility and Utilities SME
- Develop and execute protocols (CQ, IQ, OQ, and PQ) for the facility HVAC systems (AHU01, AHU03, AHU05, AHU06, AHU22, & AHU23), High Purity Water Systems (USP18), BMS software system and BAS software systems and Gamma Sterilization. Provide peer review for associates validations activity and report writing for the completed protocols
Terumo CVS, Ann Arbor, MI July – November 2014
Senior Quality Engineer
- As a member of the quality team, my duties would include remediation activities for Test Method Validation within the Incoming Quality Assurance (IQA) for dimensional checks for both variable and attribute conditions.
- Remediation of training, procedure development and calibration were included in the requirements to ensure a viable and accurate inspection system.
Zimmer , Warsaw, IN July 2013 – July 2014
Senior Quality Engineer
- As a member of the quality team for Trauma, my duties would include remediation activities for Process Validation (IC-9) within packaging and labeling, Remediation of NCR's that were long overdue for corrective action, establishing product specific packaging requirements and remediation of the Design History Files (DHF) for the Class II & III product lines, implants and instruments.
- Utilized Zimpack to identify the packaging setup sheets with instructions for use (IFU) and the labeling requirements for the product use, identification, storage and handling. Interfaced with the suppliers to identify resolutions for the NCR's related to their products and use of material by Zimmer.
Invacare, OH September 2012 – July 2013
Project Manager
- As a member of the GxP Systems team and under the Invacare organization of Process Engineering, my duties would include proper guidance and support to commission and validate the facility, utilities, equipment and processes that will be used the manufacturing of Class I & II medical devices.
- This activity included the planning and execution of decommissioning equipment and processes for relocation from US to Mexico. Instrumental in developing a validation system within quality to ensure adequate testing for reliability and reproducibility of the manufactured parts and assemblies.
- Provided leadership and guidance in the development of TMV process, Commissioning, Validation and MVP document.
Zimmer, Warsaw, IN May 2011 – September 2012
Senior Quality Engineer
- As a member of the product development team and the organization of quality, my duties would include proper guidance and support to verify and validate the equipment and process that will be used to produce the new product design.
- This activity included the planning and execution of transferring the equipment and processes from the US to PR and Ireland. Generated project plans, schedules, cost analysis and coordination of contractors to facilitate the installation and commissioning of the equipment and processes.
- Prepare appropriate measurement techniques and methods that would provide an accurate representation of the product specifications to the design drawing.
- Prepare documentation and validation for product transfer for domestic and international involvement.
Beckman Coulter, Chaska, MN March – May 2011
Senior Quality Engineer
- Perform gap analysis of the quality system. Develop Master Validation Plan and revise procedures to remediate the observations noted in preparation for re-validation activity that would close the gaps and increase the confidence level going forward.
St. Jude Medical, Irvine, CA November 2010 – March 2011
Senior Quality Engineer
- Define, document and implement validation master plans for remediation activity associated with EP Catheters.
- Developed and executed attribute and variable Test Method Validation protocols and reports for the inspection processes.
- Developed and executed Process Performance Qualification protocol and reports for EP Catheters.
- Provided guidance, support and planning to cost the transfer of equipment and processes.
Abbott Diabetes, Whitney, UK August – November 2010
Senior Quality Engineer
- As a member of the product development team and the organization of quality, my duties would include proper guidance and support to verify and validate the equipment and process that will be used to produce the new product
Quality System Technologies of Anderson, Inc. (QST), Belton, SC
Director of Operations
- Performed quality assessment, gap analysis of the production processes utilized in production of diabetes strips at the Whitney, Oxfordshire facility.
- Reviewed the findings with the management team for Abbott and to discuss remediation activities necessary to remedy the gaps that would restore the confidence in the product produced in the manufacturing.
Gyrus, Minnetonka, MN March – August 2010
Supplier Quality Auditor
Quality System Technologies of Anderson, Inc. (QST), Belton, SC
Director of Operations
- Submitted pre-audit surveys to suppliers providing services to Gyrus, Olympus. Prepared audit schedule for suppliers needing to be audited by classification. Prepare audit agenda for full quality audits to ISO 13485 or specific audit to ISO 17025. Led audits per established agendas. Submitted closing oral and written reports at the end of the audit to Gyrus for their review and evaluation.
Stryker Medical, Portage, MI November 2009 – February 2010
Project Manager - Quality
- Remediated 483 Observations identified in a 2009 audit. Prepared and presented responses to the regulatory agency as to the plan progress and performance of the remediation activity, and provided technical support to quality and regulatory personnel that achieved a higher level of regulatory compliance.
- Prepared and implemented a QSIP program to improve product quality and compliance with regulations. Led critical CAPA projects associated with field product failures, including root cause analysis and implementation of corrective actions.
- Additionally, developed SOP's and Work Instructions, Training Curriculum, Validation and CAPA Project Plans, Requirement Specifications, Traceability Matrix, IQ/OQ/PQ or CQ protocols with associated Test Cases and Final Reports. Also, audited training programs and provided training to the trainers.
Zimmer , Warsaw, IN - April 2008 – October 2009
Sr. Quality/Validation Engineer
- Responsibilities as the Sr. Quality Engineer included development and execution of a shelf life process that would comply with domestic and international regulations. Started at the Minneapolis facility and transferred to a facility in Warsaw, IN for Global Quality Improvements. Owned multiple CAPA's related to shelf life, contract manufacturing and product functionality, and drove these CAPA's to closure.
- The products that are re-validated will in many cases extend the expiry date from a 3-year shelf life to 5 or even 10 years. This effort will reinforce the present claims as well as extended the storage life of the product for longer periods of time. The procedure, protocol template and report template was developed in this process to expedite the use and training of this procedure. Training was performed for manufacturing engineering, product development and marketing.
- Performed risk analyses on existing products by define the process flow and determining through fault tree analysis what potential failures could occur. The potential failures were examined for redesign, control measures or training. GAP analysis was performed for the Design FMEA for the product and for the Process FMEA for the manufacturing process to ensure compliance to the end user's specifications as related to the relocation of a manufacturing venue.
- Led a cross-functional team through the development of the project plan for the relocation of a contract manufacturing site from one facility to another within the MN area to include project plan, cost analysis, coordination of contractor support for installation and commissioning, validation, risk assessment, and developed a PFMEA to ensure that the product was maintained in a validated state at the completion of the project. The facilities, utilities, equipment were examined closely to ensure proper operation and maintenance reliability. Protocols for Cleaning Processes, Gamma Sterilization and Packaging Processes were developed and executed. Additionally, statistical analyses of process capabilities were performed, and the reliability of calibration and maintenance systems was determined.
Angiotech, Reading, PA December 2007 – April 2008
Sr. Quality Engineer
- Developed and executed protocols for facility utilities, equipment, test methods and software validation, and provided validation training and quality support. Developed and executed validation documentation for the Class 8 (100,000) Clean Room, steam, Eto and Gamma Sterilization, Instron, Chatillon, shelf-life chambers, Despatch Ovens, Targeted Bar Sealers, Multi-Vac and Klockner packaging systems.
GYRUS ACMI, Bartlett, TN May 2007 – December 2007
Sr. Quality Engineer
Quality System Technologies of Anderson, Inc. (QST), Belton, SC
Director of Operations
- Directed the relocation of manufacturing processes from UK and the USA to a new facility in Mexico.
- Provided scheduling, planning and costing of all aspects of the move through the completion and acceptance through PAI.
- Developed and executed protocols for software validation Gage Insite Calibration Program located in Memphis, TN. Provided validation training and quality support of the calibration program at the Memphis facility.
- Developed and executed validation documentation for the Class 8 (100,000) Clean Room and gamma sterilization in Saltillo, MX.
- Audited legacy validation data and facility SOP's per 21CFR-820 and ISO 13485 requirements, then opened and initiated several CAPA's to address system deficiencies that caused the observed gaps, and wrote improved procedures and trained employees.
Boston Scientific, Miami, FL February 2007 – May 2007
Sr. Quality Engineer
- Performed a gap analysis against 21CFR-820 and ISO-13485 requirements for qualification of attribute and variable test methods, and then conducted remediation activities to close the gaps through re-validation and other corrective actions. Statistical analyses were performed to determine repeatability and reproducibility of test methods, as well as the process capability to detect defective product from acceptable product.
Military Service
South Carolina Army National Guard 2-263ADA Homeland Security, Noble Eagle, Clear Skies
NCOIC/Sr. AMDWS Operator May 2005 – January 2007
- Mobilized May 3, 2005 for initial training and mobilization at Ft. Bliss as a Radar Operator. The training was for the purpose of serving in a joint-integrated air defense mission to provide security in the vicinity of Washington, DC. Responsibilities included the set up and operation of associated equipment, management and training of 12 subordinates.
- Developed and managed work assignments, transportation and schedules associated with mission requirements. Equipment maintenance requirements were managed and executed within the team.
Quality System Technologies of Anderson, Inc. (QST), Belton, SC December 1999 - Present
Director of Operations
- Director for over 30 personnel in 7 geographical locations that I have managed from California to the east coast and from Delaware to Florida at facilities such as Playtex Products, Tyco Kendall, Bausch & Lomb, Abbott Labs, Oread, Welch Allyn from Jan 2000 to Jan 2012. The personnel I selected, staffed and supported were utilized for new product development, 483 remediation, calibrations, process validation and training.
- Responsibilities included the execution of Validation Protocols (IQ, OQ, PQ, PV, DV, and SW), training client personnel in the current regulations and industry standards in the development of quality documentation to support manufacturing environments such as; Bulk Chemical Pharmaceutical products, Medical Devices, Finished Pharmaceuticals for prescription and over the counter (OTC), Biotechnology services and automated equipment/process systems. Assisted in the development, automation, and implementation of global CAPA systems, Complaint Management Systems, Audit Tracking Programs, Management Review Processes, Risk Management Systems, PLM Systems, Supplier Quality Management Systems using TrackWise, Process Control Tracking and Trending Systems, Verification and Validation Traceability Systems, Recall Management Programs, Training Traceability Programs, and other QMS systems. Validation protocols were developed and executed for several automated manufacturing processes. The scope of the validation process included the development of Standard Operating Procedures (SOP) for the operation, maintenance, calibration, and cleaning processes and Calibration System, Document Control Procedures and Validation Documentation. Quality documents included but were not limited to Master Plans, Protocols (IQ, OQ, PQ, PV, DV, and SW) and production records.
Validation Associates, Inc. (VAI), Greenville, SC October 1998 – November 1999
Director of Operations
- Director for a team of 10 personnel in multiple location where the personnel were utilized to perform software validation, process validation, audits, CAPA plans and remediation activity to prevent a consent decree from being issued by the FDA. The personnel were working in Glendale, CA; Thousand Oaks, CA, Duarte, CA, LA, CA; Lessines, Belgium; and Austria.
- Developed Validation Master Plans and Validation Protocols (IQ, OQ, PQ, PV, DV and SW) supporting Manufacturing at a Biotechnology Division of Baxter Healthcare. Additionally, set up a CAPA program. This included initiation, planning, assignment of CAPA Owners and program oversight for multiple CAPA’s needed to resolve Quality System and Manufacturing Nonconformities that had been identified through internal audits.
Covance Biotechnology Services, Inc., Raleigh, NC March 1998 – October 1998
Sr. Quality Engineer
- Executed the MES and BMS for a new biotech manufacturing facility, this included basic engineering, detailed engineering and design, construction and start-up of new production facility or modification of existing facilities, as well as the infrastructure. Major responsibilities included:
- Implementation of BMS or MES systems, establishing plant standards, policies/procedures, special studies/analyses of process and control to meet BMS and governmental requirements, Innovation in areas where no precedent exists, Assistance with the effective deployment of business and technical resources in pursuit of engineering opportunities. Development of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols. Protocols were developed utilizing the software “WordPerfect 6.1" and P&ID revisions utilizing AUTOCAD rev.12 for sterilization, bioreactors, fermenters, CIP, SIP, Freezers, Cold Rooms, Nitrogen freezers, cryolife processing, Inoculations process of fermentation units. Clean gases, HVAC, WFI water systems, etc.
Kvaerner John Brown, New Jersey December 1996 – March 1998
Project Engineer
- Responsibilities include developing and executing for the performance & process validation. The process validation consisted of review and approval of the Engineering Installation Manuals produced by Fluor Daniel personnel as substitution for the Installation Qualification (IQ), the development and execution of the Operational Qualification (OQ) and development and execution of the Performance Qualification (PQ) protocols for the facility, utilities, equipment, processes and automated/software systems.
- This contract manufacturing facility is uniquely designed to be totally controlled through automated/software services such as; Building Maintenance Systems (BMS), Manufacturing Environment Systems (MES), and Distributive Control System (DCS). These systems monitor and control all of the manufacturing functions for this facility. As the Sr. Validation Specialist the additional responsibilities for protocol reviewer for these systems were performed to ensure that the validation effort put forth was satisfactory. Worked with Wyeth Ayerst in the validation of the flu vaccine shot manufacturing process. This injectable was uniquely located in a new facility to house and manage all facility, utility, equipment and processing of the vaccine product preloaded in syringes for expedient delivery.
TRS Staffing/Fluor Daniel Corporation, Greenville, SC June – December 1996
Sr. Project Engineer
- Developed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols for a new Biogen Facility (biotech), located in the Research Triangle Park.
- The protocols developed were for the facility, utilities, equipment and processes. Developed and executed commissioning protocols (IQ/OQ) and PQ protocols for Air Handlers/HVAC System to include BMS System. Performed system walk downs to verify as-built drawings (IQ), performed execution of temperature mapping for static and dynamic conditions, (OQ). Commissioned Compressors, Clean Gases, Backup Generators and Chiller/Cooling Towers.
- Was instrumental in clarifying several GMP issues that were in question as they attempted to answer the needs of the protocols. Performed training operations to assist fellow colleagues in the cGMP requirements. Training included the proper procedure in developing and executing validation protocols.
Validation Associates, Inc. (VAI) October 1993 – June 1996
Sr. Quality Engineer
- Responsibilities included the development process for quality documentation in support of the manufacturing environments such as; Bulk Chemical Pharmaceutical products, Medical Devices, Finished Pharmaceuticals for prescription and over the counter (OTC), Biotechnology services and automated equipment/process systems.
- Prepare Validation Master Plans and Protocols (IQ, OQ, PQ), Standard Operating Procedures, and production records.
- Validation protocols were developed and executed for systems like the Software for Delta T Illusions Casting Machine, Software and equipment validation for the Auto Inspection System (12), the Print Tint Machine (4), and Optoform 50 Lathe Machines (12), Lyophilizer, Desiccators, Sterilizers-AMSCO/Fedegari/Getinge, Laboratory Analytical Equipment and several manufacturing processes. Developed and executed commissioning protocols (IQ/OQ) and PQ protocols for Air Handlers/HVAC System to include BMS System. Performed system walk downs to verify as-built drawings (IQ), performed execution of temperature mapping for static and dynamic conditions, (OQ). Commissioned Compressors, Clean Gases, Backup Generators and Chiller/Cooling Towers.
Midwest Technical Incorporated October 1987 – July 1993
Design Engineer
- Primary responsibilities included working in a cross functional team consisting of Validation Technology, Pharmaceutical Services, Production, and Quality Assurance, Research and Development and Analytical Research personnel to ensure that products produced under Process Validation protocols were sampled and tested in strict compliance with requirements.
- Validated Micro and Analytical Lab environments, utilities and equipment, including a robotic auto sampler, clean gases, Purified water systems, dishwashers, autoclaves, HPLC and GC and other counter top equipment. Developed and executed commissioning protocols (IQ/OQ) and PQ protocols for Air Handlers/HVAC System to include BMS System.
- Performed system walk downs to verify as-built drawings (IQ), performed execution of temperature mapping for static and dynamic conditions, (OQ). Commissioned Compressors, Clean Gases, Backup Generators and Chiller/Cooling Towers. Develop and executed protocol against URS/FRS (Design Specifications) to qualify a new BMS, MES and PRMS.
- Validated new and modified the design for Purified/CIP Water systems. The Purified water system was modified to be continuously sanitized with the use of Ozone and UV lighting. The POU was interlocked and controlled with visual and audible indicators in conjunction with ozone detection systems