Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Professional with solid technical and compliance knowledge, skilled in research and development, manufacturing, operations, validation, and quality engineering. Broad experience gained working over twenty years with pharmaceutical, device and biologics manufacturers. Background in the manufacture of solid dosage, liquids, creams and ointments, Class I and II medical devices (cardiovascular, urological, and reconstruction  products), with knowledge of a broad range of manufacturing and packaging equipment, including stirrers, mixers, fillers, washers, sealers, granulators, compression, Glatt and spray dryers, SIP systems, purified water systems, storage tanks, and high speed pumps, etc.

CORE COMPETENCIES

  • R&D/Design Controls
  • Design Changes/DHFs/DMRs
  • Specifications/Drawing Analysis
  • Risk Management /FMEAs/Hazard Analysis
  • Audits/Gap Analysis/Remediation
  • Quality Engineering/ Quality Assurance
  • Project Management/Tech Transfers
  • Process Improvement/Quality Initiatives
  • Cleaning/Sterilization/Validation
  • ISO 9000/ISO 13485/ISO 14971
  • 21 CFR Part 11/GAMP 5
  • 21CFR Parts 110/210/211/801/803/820
  • Recalls/Complaints/CAPA/Root Cause
  • Quality Plans/Manufacturing Plans
  • Biocompatibility Reports
  • Labeling/Storage/Handling
  • Package Sealing/Methodologies
  • Material Specifications/Components Instruments/CTQ attributes
  • Supplier Specifications/Audits/Monitoring
  • Purified Water Systems
  • Facilities/Commissioning/Utilities Environmental Monitoring
  • Change Control/Authoring/Reviewing
  • Inspections/1st Article
  • Start-Up/Sampling/Line Clearance

SELECTED ACCOMPLISHMENTS

  • Served as Director/Project Manager for fortune 500 company, consolidating three manufacturing facilities in to two major divisions, including:
    • Conducted Quality Audits at three facilities prior to Tech Transfer activities
    • Directed multi Pharmaceutical/OTC client sites with specific oversight over Quality Reviews, cGMP’s, Canadian Drug Laws and FDA compliance adherence, Quality Review and CAPA authoring
    • Managed staff of Project Managers and developing project timelines through Microsoft Project
    • Served as representative for FDA inspections
  • Served as project manager on development and validation of new laboratory and commissioning vaccine facility
  • Project managed validation of medical device manufacturers
  • Authored Risk Management, DFMEA, AFMEA and PFMEA documentation for Class I, II devices
  • Conducted DHF audits and remediation activities in support of FDA, EMEA and LAPAC governing bodies
  • Served as team member in design development and launch of new product lines for Recon Division
  • Conducted GAP analysis for medical device, pharmaceutical and biotech industries
  • Served as divisional QE/QA representative for design control/product realization activities including but not limited to classification of quality characteristics, design inputs and review, technical drawings and specifications, design verification and reliability and maintainability
  • Authored reports for third party contract manufactures
  • Reviewed and edited, test methods, labeling, sterilization and packaging documentation
  • Implemented and managed product quality programs, including component qualification, inspection and test methodologies, supplier qualification, developing and maintaining the quality plans, reviewing gauge R&R studies, test methods, preventative maintenance and calibration programs
  • Served as team member involved in establishing quality system (QSIT) in Medical Device facility
  • Represented quality assurance in tasks of development and manufacturing to ensure process capability and quality tools and systems are compliant prior to product launch.
  • Provided input into development studies, IQ/OQ/PQ validation plans, deviation reports (root cause analysis), and protocols as necessary
  • Ensured test plans/test protocols met ANSI/AMMI and ISO Standards per test methodology
  • Supported change control for existing products through review of engineering reports, drawing changes, supplier evaluations, review of biocompatibility and Bio burden analysis and design change paperwork
  • Defined, selected, and applied various techniques including supplier qualification, certification, evaluation, ratings, performance improvements for development and selection of suppliers during the product development process
  • Served on product complaints handling, Health Hazard Evaluations (HHE) and product recalls team
  • Authored biocompatibility documents for Recon product lines (components and instruments)
  • Reviewed and approved change requests through the Wind-chill PDM System, Blue Mountain and SAP, CAPA initiation, review and approval, quality audits, and Class II Atrial Fibrillation Systems
  • Developed process validation protocols and validation of medical device molding processes
  • Performed quality assessment of manufacturing deviations (determining/addressing root cause)
  • Performed deviation writing, review and approval
  • Initiated CAPA review and approval, and complaint handling training
  • Coached investigational staff on investigations, deviation writing and root cause analysis
  • Developed and authored equipment and environmental development studies (vaccines, solid dosage), technical studies, installation and operational protocols, deviation authoring and final reports for equipment in vaccine production, i.e., MES upgrade to weighing stations, (BMS) building and maintenance system validation (Software Validation, Risk Assessment, 21CFR Part 11 GAMP) communication point relocations and vial filler line validation.
  • Developed and wrote cleaning validation protocols and final reports for tunnel washer equipment used in the production of vaccines, i.e., stir bar assemblies, equipment, etc.
  • Performed clean room qualification and commissioning documentation review, CAPA and qualification (OQ and PQ executions for environmental air flows and sampling) environmental packaging equipment (fillers, vile washers, check weight equipment) building management systems (BMS), and HVAC and deviation authoring
  • Developed, authored, and preformed quality engineering review for IQ, OQ protocols final reports and deviations for medical device equipment, i.e., automated assembly machines, Software Validation, Risk Assessment, 21CFR Part 11 (GAMP), swaggers, data acquisition equipment, visions systems, induction heat sealers, Branson Welders, device sealers, leak testers, breakaway testers and Imtran printers at two facility sites (Indiana and New York)
  • Performed software validation for automated assembly machine, data acquisition equipment, welders, sealers and printers
  • Led project team for on time delivery of project documentation essential to compliance initiative
  • Performed quality review of batch records, non-conforming product, test tethods, IQ, OQ and PQ protocols (deviations) for team
  • Authored changes to Master Validation Plans (MVP) and Master Validation Reports (MVR)
  • Authored and reviewed final reports for multi validation projects
  • Reviewed and completed ergonomic profiles for manufacturing equipment
  • Provided client with innovative solution to meet compliance standards for drug storage
  • Reorganized environmental functionality to determine feasibility of upgrades to design
  • Implemented solutions for problems relating to architectural design during quality laboratory upgrade
  • Organized processes and resources to implement corrections to secure validated and operational facility
  • Designed and implemented project plan to ensure on time delivery of validation processes of new $50 mil manufacturing facility for solid dosage
  • Worked with project engineers and designers on commissioning validation processes
  • Authored IO,OQ,PQ deviation results for validation protocols for manufacturing equipment i.e., continuous coater, Human Manufacturing Interfaces (HMI), tablet compressors, laboratory equipment; water systems, laminar hoods, HVAC monitoring, and low humidity room, and packaging equipment, line clearance; metal detectors, cappers, induction heat sealers, counters, software, and vision systems.
  • Performed software validation of packing line equipment
  • Performed quality engineering review for CAPA, IQ, OQ, and PQ documents and reviewed and corrected P&IDs for manufacturing facility, i.e. HVAC, Water and Steam systems
  • Performed clean room validation, cleaning validation for vaccines, laboratory validation (LIMMS use)
  • Trained senior management personnel on authoring SOPs and work instruction procedures for their departments
  • Designed and conducted cGMP training program for bi weekly and hours employees
  • Participated in project update meetings with senior management

PROFESSIONAL EXPERIENCE

  • Integra Life Sciences, Quality Engineer (contractor for Pharma Bio Services) – 2012 to present
  • St. Jude Medical, Quality Engineer (contractor for The Experts) – 2011 to 2012
  • Sandoz Pharma, Quality Engineer (contractor for Black Diamond Network) – 2011
  • DPT Laboratories, Validation Engineer (contractor for Technical Staffing Group) – 2010
  • St. Jude Medical, Validation Engineer (contractor for RCM Technologies) – 2009 to 2010
  • Aventis, Validation Engineer (contractor for TechSource) – 2009
  • Wyeth, Validation Engineer (contractor for Integrated Project Services) – 2007 to 2008
  • American Technical Consultants, Director of Operations – 1998 to 2007
  • Barr Laboratories, Manufacturing positions, Solid Dosage – 1995 to 1998
  • Warner Lambert, Manufacturing positions, Solid Dosage – 1993 to 1995
  • Schering Plough, Mfg. and R&D positions, Solid Dosage, Liquids, Creams, Ointments – 1973 to 1993

EDUCATION

  • BS Management Science, Rutgers University – May 1991

TRAINING

  • Quality System Training – 2011
  • Complaint Handling Training – 2011
  • Blue Mountain Software & SAP – 2010
  • Kepner Tregoe Problem Solving and Decision Making Course
  • Ethnics in Business Program – 1989
  • Labor Management – 1990
  • Professional Trainer Certification – 1990
  • Glatt Air Drying School – 1989
  • Tablet Manufacturing Techniques – 1982
  • ISPE, IVT, Training Classes – 1998, 1999, 2005

AFFILIATIONS

  • ISPE [International Society of Professional Engineers]
  • PMI [Project Management Institute]
  • AMA [American Management Association]