Baxter

Intralase

MBI

Oread

QDI

B.Braun

Validations Completed
Laboratory Completed
Part 11 Completed
Documentation Completed
Accomplishments
Skills

Tasks & Projects

Baxter BioScience

(Hyland Pharmaceutical – Plasma, IV)

1. ERES Remediation Program General Tasks
   1. Follow a global approach for ERES remediation
   2. Provide a common interpretation of the Part 11 regulation
   3. Provide a common ERES remediation strategy
   4. Leverage resources and skills across all facilities
   5. Manage one divisional ERES budget
   6. Promote global collaboration for common solutions
   7. Apply a Program Management approach
   8. Manage local ERES activities through projects
   9. Manage projects through the BioScience ERES Program
   10. Govern the ERES Program through divisional and local Regulatory and Business Requirements Quality Engineering
2. Project Management
   1. Participated as a member of the ERES Core Team to develop common solutions for ERES systems.
   2. Developed and maintain project plans for all ERES projects within their functional area.
   3. Provided monthly progress reports for each project.
   4. Ensured that each remediation project is properly executed at each site.
   5. Escalated issues to the Program Director in a timely fashion.
3. Project Leadership
   1. Developed and maintained project plans for a specific ERES project within their site.
   2. Lead more than one local project.
   3. Provided monthly progress reports for this project.
   4. Ensured that the remediation project is properly executed at their site.
   5. Escalated issues to the ERES Project Manager in a timely fashion.
4. Portfolio Management - Maintained, inquired, developed, and corresponded for the following:
   1. Current list of systems to be remediated
   2. Risk assessment of each system
   3. Status of each CSV requirement for each system
   4. Status of each ERES requirement for each system
   5. Estimated cost of remediation for each system
   6. Portfolio analysis was recalculated whenever significant changes in budget, estimated costs, or business priorities occurred.
5. Developed and Maintained the ERES Document Repository on Lotus QuickPlace
6. ERES Implementation Process
7. Project Management Support Process
8. Financial Management Process
   The ERES program office approved orders.  Invoices were processed locally with a copy to the ERES PMO and an entry in the IS database.  Management reports were provided as necessary.
9. Documentation Management Process
   Documentation produced as a part of the remediation process were retained according to local procedures.    The program office developed recommended procedures for using an electronic document management system to maintain the electronic documents.
10. Inventory Maintenance
    1. Compiled an inventory of systems to be remediated at each site and forwarded it to the ERES-PMO.
    2. Assessed the following:
       1. Inventory of systems
       2. Compliance status assessment of systems
       3. Risk assessment of system according to business requirements
       4. Estimated remediation cost
       5. Updated Inventory of systems
       6. Updated Compliance status assessment of systems
       7. Updated Risk assessment of system according to business requirements
       8. Updated Estimated remediation cost
11. Documentation Collection, Review, Sorting and Verification
    1. Collected all available system documents, documented procedures and processes from all applicable document databases and stored them in the repository for availability to all sites.
    2. Review and sort the documents collected in the previous step by a number of parameters.
    3. Documents were indexed by a classification system that allowed easy retrieval for a particular system:
       1. Technology specific process documentation & templates
       2. Common Processes
       3. Site Specific Processes & Information
12. High Level Implementation Plan
    1. Compared a checklist of requirements by site-specific system with the solutions and documents available for both system validation and ERES compliance
    2. Reviewed
    3. Compliance status of system
    4. ERES compliance checklist
    5. Validation compliance checklist
    6. Available solutions & documents in repository
    7. Prepared
       1. Completed checklist (by system)
       2. Created list of additional solutions/ SOP’s/documents that need to be created to complete the checklist.
13. Detailed Implementation Plan
    1. Reviewed Site Proposals for requested funds
    2. Based on the following:
       1. High level  implementation plan
       2. Business process description
       3. Quotes by Vendor(s)
       4. Other cost estimates and product evaluations
14. Execution of Remediation Assistance
    1. Project assistance for each site as required, in the areas of:
       1. Project management and progress reviews
       2. Resolution and elevation of issues
       3. Information sharing on of technology solutions
    2. Produce:
       1. Issue resolution
       2. Global Status reports
15. Process Purchase Orders, Quotes, Requisitions, Invoices
    1. Review and approved Requisitions, based on:
       1. Relavence
       2. Correlation and adherence to proposal
       3. Verification with quoted and contractual agreements
       4. Review for global discounts
       5. Assess for global sharing of technology, software, and documentation.
    2. Acquire management approval, process, and relay approved status:
    3. Update tracking tools with the information:
       1. Deviations
       2. Scheduling
       3. Resources
       4. Taxes and contingency
       5. Update Reports and Global notification
       6. Documentation Status
16. Access dBase development
    1. Devised a system to input, track, and output reports on:
       1. Invoices
       2. Proposals
       3. Requisitions
       4. System ID #
       5. Background Info. (location, initiators, approvers, dates, etc.)
       6. Reports on Proposal costs for HW, SW, Val by facility and fiscal year, etc.
17. Team’s Technical Support
    1. Network issues
    2. Technical / Advanced training on MS Office (Excel, Word, Powerpoint, Visio)
    3. Technical / Advanced training on Lotus Notes
    4. Technical / Advanced training & support on various application errors and how to use.
    5. Training of Global and Team members on:
       1. Use of newly developed Access dBase for tracking funds, proposals, Req’s, Invoices, etc.
       2. QuickPlace Document Repository use and functions
18. Technologies – within Manufacturing Systems
    1. Allen Bradley PLCs
    2. Siemens S5/S7 PLCs
    3. Klöckner-Möller PLC, Type PS416, PS420
    4. Steris Isolator
    5. Rockwell – RSMACC
    6. GE Fanuc – CIMplicity
    7. Millipore Integra Filter Integrity Testers
    8. Emerson – DeltaV
    9. Intellution – iFIX / FIX32 / FixDmacs SCADAs
    10. Intellution – iHistorian
    11. Yokogawa Darwin chart recorder
    12. FinnAqua – Autoclave, WFI system
    13. Siemens – WinCC SCADA
    14. Wonderwear SCADA
    15. OSI/PI
    16. Kaye Validator 2000
19. Process Types – within Manufacturing Systems
    1. Primary Manufacturing Processes (Plasma Fractionation)
    2. Primary Bulk Processes (Recombinants and/or Vaccines)
    3. Primary Processes (Other Products)
    4. Secondary Bulk Process
    5. Separation Processes
    6. Finishing Processes
    7. Aseptic Filling
    8. Plant Utilities WITH product contact
    9. Plant Utilities withOUT product contact
    10. Equipment and/or Suite Cleaning processes
    11. Secondary Packaging
    12. Process Monitoring
20. System Types – within Manufacturing Systems
    1. Client-Server Lab Systems
    2. Data Historian
    3. Databases
    4. Network Infrastructure
    5. PLC
    6. Process Control Systems - PCS (DCS)
    7. Report Generators
    8. SCADA
    9. Spreadsheets
    10. Statistical Analysis Systems (SAS)

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IntraLase Corporation
(electronic – laser medical device manufacturer)

1. Quality Engineering
   1. SPC/SQC and statistical analysis for production equipment.
   2. Characterization / DOE of assembly machine.
   3. Statistical advisor.
2. Quality Assurance / Regulatory Affairs / Documentation
   1. Internal GMP, QSR and OSHA audits
   2. SOP generation and revisions.
      1. Various cleaning (facility, equipment, etc.)
      2. Quality Evaluation Procedures
      3. Maintenance of Lab and Manufacturing Equipment
   3. Equipment asset & number audit, revision, and maintenance.
   4. Project Planning of all Quality Issues using MS Project.
3. R&R Gage study on quality assurance / control inspection instrumentation.
4. Validations (IQ/OQ/PQ) Document drafting, Executions, Summarization / Reporting
   1. Manufacturing Equipment
      1. Custom designed Cone assembly machine
      2. Electric, laser output, and optic precision Test Fixtures
   2. Test Method Validations
   3. PLC - Allen Bradley RX Logix
   4. Process Validation of all processes at new facility
      1. Incoming Inspections, Inventory, quarantine / accept / reject process.
      2. Manufacturing / assembly process.
   5. Facility Validation of new 41,000 sq. ft. building
5. Management (up to 5)
   1. External Contractors
   2. Personal Staff

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MBI / UroCor
(nuclear medical device implants)

1. Quality and Validations Engineering
   1. SPC/SQC and statistical analysis in OQ and PQ phase of validations.
   2. Characterization of Semi-automatic See (source) Assembly Machine
2. Training on GMP/QSR, design control, software/computer requirements
3. Quality Assurance / Regulatory Affairs / Documentation
   1. Design Control Plan development, execution, and summarization/reporting
      1. Drawings, SOP, 510k documentation, specifications procurement
      2. Failure Modes and Effects Analysis
      3. Fault Tree Analysis
      4. Hazard Analysis
   2. Internal GMP, QSR and OSHA audits
   3. SOP revisions and drafting
      1. Magnahelic Use
      2. Calibration
      3. Maintenance of Lab and Manufacturing Equipment
         1. Gamma Counter
         2. Ovens
      4. QA policy
      5. Corrective Action Program
      6. Design Control Plan, HA, FMEA, FTA
      7. Raw Material Specifications revisions and generations.
      8. Change Control Procedure
   4. Equipment asset & number audit, revision, and maintenance.
   5. Project Planning of all Quality Issues using MS Project.
4. Validations (IQ/OQ/PQ) Document drafting, Executions, Summarization / Reporting
   1. Manufacturing Equipment
      1. Laser Titanium Welders
      2. Gamma Counter and auxiliary equipment
      3. Seed (Source) Assembly Machine
      4. Multi-Channel Analyzer System and auxiliary equipment
      5. Seedburo Seed Counter
      6. Capintec Gamma Dose Calibrator Machine
      7. Brachytherapy source Heat Stress Equipment
   2. Process and Batch
      

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Oread Pharmaceuticals
(contract pharmaceutical manufacturer)

1. Quality and Validations Engineering
   1. SPC/SQC and statistical analysis in OQ and PQ phase of validations.
   2. Air change Calculations
   3. Sampling and AQL development based on ANSI z1.9 and 1.4
2. Quality Assurance / Regulatory Affairs / Documentation
   1. Cleaning Specifications SOP generation
   2. SOP revisions and drafting
      1. Maintenance Manufacturing Equipment
   3. Audits
      1. WFI systems
      2. Internal GMP and OSHA audits
      3. Validations Records
      4. Batch Verification
      5. Batch Manufacturing Specifications Criteria Generation and associated SOP’s
      6. Regular Steering Meetings for Validations Coordination
      7. Audit Responses to several Clients
   4. Stability Trending
3. Validations (IQ/OQ/PQ) Document drafting, Executions, Summarization / Reporting
   1. Manufacturing Equipment
      1. Beta Press Tableting Machine.
      2. Nordenmatic semi-solid filling machine.
      3. Compounding Homogenizing Tanks
   2. Process Validation
   3. Cream Filling / Packaging Process
   4. Team IT support
   5. Technical Transfer Support
      1. Completion of Validations
      2. Audit Responses
      3. Client Response
         1. Parameter and SOP tracking and completion
         2. Calibration Management
         3. Manual Tracking
         4. Documentation Tracking
         5. Stability Tracking
      4. Relocation Assistance
         

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Qualisys Diagnostics, Inc. (QDI)
Class II level medical device diagnostics manufacturing facility

1. Quality and Validations Engineering
   1. Design of Experiment
      1. Conducting own experiments
      2. Taguchi methodology
      3. Process capability, normality analysis, and sample analysis.
   2. Product design improvements planning
   3. Product and raw material prospective evaluation.
   4. Statistical Process Capability (SPC) charting.
   5. Statistical Quality Control (SQC) implementation.
   6. FMEA, FTA, HA (Failure Modes and Effects Analysis, Fault Tree Analysis, Hazard Analysis)
      1. Sample Injector
      2. Assaying Device
   7. Feasibility and Stability runs using Arhenius equation and 3rd order kinetics.
   8. Validations
      1. IQ/OQ/PQ
         1. Lab Equipment and production equipment
            1. Mixers
            2. Centrifuges
            3. FPLC
            4. Reagent Fillers (centripetal)
            5. Bag Fabricator
            6. Labeling Devices
            7. Fractionator
            8. Water Purification Device (Nanopure)
         2. Test Method validations
            1. QC method for raw components dimensional testing.
            2. QC method for sampling of voltage, resistance, capacitance on raw components.
            3. QC test method for biotin binding capacity.
            4. QC test method for protein purity.
            5. QC test method luminescent reagent purity.
            6. QC test method raw material purity on reagents and components.
            7. QC test method using FPLC for assay.
         3. Cleaning
            1. Compounding Equipment
               1. pH, conductivity, protein residue, detergent level, TOC
            2. Process Validations
               1. Compounding Process for Antibody, Microparticles, Wash Buffer
               2. Filling Precision and Accuracy
         4. Validations & Verifications - assisted outside contractors with software validations.
            1. Sample Injector
            2. Assaying Device
         5. Facility
      2. Training
         1. Training personnel in QSR,  cGMP's, GLP, OSHA and ISO9000's
         2. Computer applications training.
      3. Information and Technical Systems
         1. Customized databases for collecting and controlling information from instrumentation, metrology, maintenance, documentation, purchased chemical control, indentured lists, and other controlled systems.
         2. All aspects in rolling in new systems and peripherals.
         3. All technical support - (hardware and software)
         4. Programming (Excel, Access, and VBA related)
         5. Troubleshooting
         6. Training and assistance
            1. Word, Excel, Access, Win95/98/NT, Project, Luminometer software, etc.
            2. Rosys Anthos Robotics (AutoLucy)
      4. Production and Process Engineering
         1. Making suggestions for improvement of process.
         2. Implementing facility design into projected product production area
         3. Challenging designed process plans.
         4. Feasibility runs.
      5. Documentation (Revision of existing SOP's and generation of new)
      6. Incoming Material Inspection
         1. Development of database tracking system.
         2. Development and implementation of labeling system.
         3. Development of QC sampling and testing, stability retention, approval, quarantine, MRB assignment.
      7. Purchasing
         1. Responsible for tracking and purchasing lab supplies, information, and equipment
            1. Responsible for over $750,000 purchased in capital.
            2. Budgeting purchases
            3. Correspondence with suppliers: VWR, Scientific Products, Fisher, OHAUS, Omega, etc.
      8. Inventory Control
      9. Quality Assurance
         1. Certification of new suppliers/vendors.
         2. Purchased Chemical Control
         3. Supporting two 510(k) processes and a PMA.
         4. CE mark and MDD (Medical Device Directive) support.
      10. Industrial Hygiene and Safety:
          1. Biohazard program with blood-borne pathogens
          2. Waste management program, identification and documentation
          3. GLP's and all associated safety mechanisms
          4. Fire safety program and documentation
          5. Emergency evacuation program
          6. EPA (Hazardous Waste and OSHA regulations).
      11. Metrology
          1. Corresponding with local contracting agencies in the implementation of calibration system.
          2. Assuring NIST traceability is maintained with all applicable instrumentation
          3. Exploring cost vs. in house calibration alternatives
          4. Implementing Handbook 44 and 130 in calibration procedures.
          5. Accounting all equipment is traced and applicable calibration schedule is maintained.
          6. Performed Calibration and R&R.
             1. Pipettes
             2. Balances
             3. Mixers
             4. Thermometers
             5. Graduated Cylinders
      12. Maintenance (preventive and emergency)
          Creating and implementing of maintenance program for lab equipment and production equipment as they are being acquired.
           

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Quality / Validation Engineering - B Braun | McGaw
Intravenous Pharmaceuticals & Parenteral Manufacturer

1. Product complaints investigation - Product Service/Incidence Report (PSR/PIR)
2. Decontamination processing of returned product (hazardous materials approach)
3. Physical evaluation
4. Coordination of product testing with laboratories (e.g. chemistry, microbiological, BTC, engineering, etc.)
5. Summarization of laboratory results in technical reports
6. Issuance of corrective action if applicable
7. Identifying areas of common product issues and presenting suggestions for product improvement and trend analysis
8. Validations (Installation, Operational, and Performance Qualification) (see Validations & SubValidations)
   1. PLC, systems (retrospective), facilities, equipment and product
   2. Protocol generation and execution
   3. Coordination of validations with applicable departments
   4. Validation summarization
9. Product Test Run Authorization execution and creation of testing method
10. Some - Design of Experiment generation, coordination and execution
11. Statistical evaluation with respect to Cpk, confidence level, military standards, etc.
12. Final deposition of product based upon the statistical evaluation and product performance
13. Quality Control Release Verification (QCRV) coordination
    1. Review of Maintenance Orders and assignment of Change Control Validation or QCRV
    2. Coordination of sampling plans and required testing with laboratories
    3. Release of classified and controlled facilities, distilled/deionized/softened water, compressed air, pumps, steam, sterilizers, etc. upon receipt of applicable data in compliance with company and government regulations
    4. Addressing problem facilities/systems/products and identifying trends
    5. Tracking the maintenance progress and laboratory results
14. Meeting presentations - As Acting Chairperson
    1. Product investigation updates and statistical evaluation
    2. Validation updates and coordination
    3. QCRV / Change Control Request coordination meetings with maintenance department and laboratories
15. SOP generation/revision and Document Orders
    1. Revision of Standard Operating Procedures, Technical Information Standards, etc.
    2. Creation of quantitative sampling plan with aid of mil. standards or other statistical approach
16. Knowledge of Plastics and LVP fabrication / filling
    EXCEL®, DUPLEX™, PAB®, Glass, PIC™, Add-A-Vial®, addEASE, Compounding, SafeLine®, Injection Molding, Blow Molding, Film Extrusion
17. Technical Training of Personnel
    1. Computer training - Windows/NT, Excel, Word, Network (Novell), Lotus Organizer & Notes
18. New Test Methods, Validation, QC Release Verification
19. Technical Assistance
    1. Computer, applications, network, printer and other assistance
    2. Requalification / Validation approach and procedures
20. Internal Audits (Routine and unscheduled facilities and process audits)
21. Involved with teams, in efforts of modernizing and improving specific aspects of the company
     

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