Intralase Corporation (electronic laser medical device manufacturer) Quality Engineering SPC/SQC and statistical analysis for production equipment. Characterization / DOE of assembly machine. Statistical advisor. Quality Assurance / Regulatory Affairs / Documentation Internal GMP, QSR and OSHA audits SOP generation and revisions. Project Planning of all Quality Issues using MS Project. R&R Gage study on quality assurance / control inspection instrumentation. Validations (IQ/OQ/PQ) Document drafting, Executions, Summarization / Reporting Manufacturing Equipment Test Method Validations PLC Process Validation of all processes at new facility Facility Validation of new 41,000 sq. ft. building Management (up to 5) External Contractors Personal Staff MBI / UroCor (nuclear medical device implants) Quality and Validations Engineering SPC/SQC and statistical analysis in OQ and PQ phase of validations. Characterization of Semi-automatic See (source) Assembly Machine Training on GMP/QSR, design control, software/computer requirements Quality Assurance / Regulatory Affairs / Documentation Design Control Plan development, execution, and summarization/reporting Internal GMP, QSR and OSHA audits SOP revisions and drafting Project Planning of all Quality Issues using MS Project. Validations (IQ/OQ/PQ) Document drafting, Executions, Summarization / Reporting Manufacturing Equipment Process and Batch Tasks at Oread Pharmaceuticals (contract pharmaceutical manufacturer) Quality and Validations Engineering SPC/SQC and statistical analysis in OQ and PQ phase of validations. Air change Calculations Sampling and AQL development based on ANSI z1.9 and 1.4 Quality Assurance / Regulatory Affairs / Documentation Cleaning Specifications SOP generation SOP revisions and drafting Audits WFI systems Batch Verification Batch Manufacturing Specifications Criteria Generation and associated SOP's Regular Steering Meetings for Validations Coordination Audit Responses to several Clients Stability Trending Validations (IQ/OQ/PQ) Document drafting, Executions, Summarization / Reporting Manufacturing Equipment Process Validation Team IT support Technical Transfer Support Completion of Validations Audit Responses Client Response Relocation Assistance Tasks at Qualisys Diagnostics, Inc. Class II level medical device diagnostics manufacturing facility Quality and Validations Engineering Design of Experiment Product design improvements planning Product and raw material prospective evaluation. Statistical Process Capability (SPC) charting. Statistical Quality Control (SQC) implementation. FMEA, FTA, HA (Failure Modes and Effects Analysis, Fault Tree Analysis, Hazard Analysis) Feasibility and Stability runs using Arhenius equation and 3rd order kinetics. Validations Lab Equipment and production equipment Test Method validations Cleaning Process Validations Validations & Verifications - assisted outside contractors with software validations. Facility Training Training personnel in QSR, cGMP's, GLP, OSHA and ISO9000's Computer applications training. Information and Technical Systems Customized databases for collecting and controlling information from instrumentation, metrology, maintenance, documentation, purchased chemical control, indentured lists, and other controlled systems. All aspects in rolling in new systems and peripherals. All technical support - (hardware and software) Programming (Excel, Access, and VBA related) Troubleshooting Training and assistance Production and Process Engineering Making suggestions for improvement of process. Implementing facility design into projected product production area Challenging designed process plans. Feasibility runs. Documentation (Revision of existing SOP's and generation of new) Incoming Material Inspection Development of database tracking system. Development and implementation of labeling system. Development of QC sampling and testing, stability retention, approval, quarantine, MRB assignment. Purchasing Responsible for tracking and purchasing lab supplies, information, and equipment Responsible for over $750,000 purchased in capital. Budgeting purchases Correspondence with suppliers: VWR, Scientific Products, Fisher, OHAUS, Omega, etc. Inventory Control Quality Assurance Certification of new suppliers/vendors. Purchased Chemical Control Supporting two 510(k) processes and a PMA. CE mark and MDD (Medical Device Directive) support. Industrial Hygiene and Safety: Metrology Corresponding with local contracting agencies in the implementation of calibration system. Assuring NIST traceability is maintained with all applicable instrumentation Exploring cost vs. in house calibration alternatives Implementing Handbook 44 and 130 in calibration procedures. Accounting all equipment is traced and applicable calibration schedule is maintained. Maintenance (preventive and emergency) Creating and implementing of maintenance program for lab equipment and production equipment as they are being acquired. Quality / Validation Engineering - B Braun | McGaw Intravenous Pharmaceuticals & Parenteral Manufacturer * Product complaints investigation - Product Service/Incidence Report (PSR/PIR) * Identifying areas of common product issues and presenting suggestions for product improvement and trend analysis * Validations (Installation, Operational, and Performance Qualification) (see Validations & SubValidations) PLC, systems (retrospective), facilities, equipment and product Protocol generation and execution Coordination of validations with applicable departments Validation summarization Product Test Run Authorization execution and creation of testing method Some - Design of Experiment generation, coordination and execution Statistical evaluation with respect to Cpk, confidence level, military standards, etc. Final deposition of product based upon the statistical evaluation and product performance Quality Control Release Verification (QCRV) coordination Review of Maintenance Orders and assignment of Change Control Validation or QCRV Coordination of sampling plans and required testing with laboratories 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 Addressing problem facilities/systems/products and identifying trends Tracking the maintenance progress and laboratory results Meeting presentations - As Acting Chairperson Product investigation updates and statistical evaluation Validation updates and coordination QCRV / Change Control Request coordination meetings with maintenance department and laboratories SOP generation/revision and Document Orders Revision of Standard Operating Procedures, Technical Information Standards, etc. Creation of quantitative sampling plan with aid of mil. standards or other statistical approach Knowledge of Plastics and LVP fabrication / filling EXCEL®, DUPLEX, PAB®, Glass, PIC, Add-A-Vial®, addEASE*, Compounding, SafeLine®, Injection Molding, Blow Molding, Film Extrusion Technical Training of Personnel Computer training - Windows/NT, Excel, Word, Network (Novell), Lotus Organizer & Notes New Test Methods, Validation, QC Release Verification Technical Assistance Computer, applications, network, printer and other assistance Requalification / Validation approach and procedures Internal Audits (Routine and unscheduled facilities and process audits) Involved with teams, in efforts of modernizing and improving specific aspects of the company LABORATORY McGaw | Braun, Allergan, and Qualisys Chemistry · Infra Red Spectrum analysis - Perkins Elmer (Liquid and Solid) · Gas Chromotography - Hewlette Packard 6890 II · Standards and Sample testing · Obtaining results within a minimum of 99% correlation of obtained Linear Regression · Maintenance of machine, peripherals, computer, printer, gas delivery, headspace, gas tanks · Troubleshooting · Spectrophotometer (UV and visible) · pH analysis (Electronic and Titration method) · Atomic Absorption analysis · FPLC (Pharmacia) / HPLC (familiarity) · Fractionating (Pharmacia) · IMx (Abbott) Spectrophotometry (familiarity) · Immunoassay techniques / Enzyme reactions (manual / robotics - Tecan / Autolucy Anthos Rosys) · EIA and use of software to characterize enzyme activity · Luminescence (Zylux Luminometer system) Biological · Biochemical · Electrophoresis · Western Blotting · Immunoblotting · Microbial · Limulase Amebocyte Lysate (clot) testing of surgical devices · Auxonographic testing of Antibiotic affectivity · Bioburden testing of air water, plastics, surgical devices, and solutions · Filtration and incubated growth on TSA plate · Heat Shock · Inoculating & Enumeration · General biochemical ID techniques Gram Staining, acid-fast stain, OF-Glucose, Oxidase, Catalase, etc. · Surface testing (RODAC and Swab) · Sterilizer use - Castle / Amsco Environmental Monitoring · Particulate Matter monitoring in water and air using HIAC or MetOne · Velocity of air using AIRVELO · Pressure, temperature, and humidity monitoring · HEPA hood leak testing · Data trending · LIMS Engineering · Instron (basics) · Comparitor · Oscilloscopes (various) · Multimeter (Fluke and other) Other (Microcalipers, Tensiometer, Fluid / Air flow meters, Pressure gauges, Filter integrity testers, Radiation Dose Meters, IR thermometers, Thermocouple / RTD, Kaye Validator Digistrip) |
PERFORMANCE HIGHLIGHTS |
Intralase Corporation (electronic laser medical device manufacturer) Quality Engineering SPC/SQC and statistical analysis for production equipment. Characterization / DOE of assembly machine. Statistical advisor. Quality Assurance / Regulatory Affairs / Documentation Internal GMP, QSR and OSHA audits SOP generation and revisions. Project Planning of all Quality Issues using MS Project. R&R Gage study on quality assurance / control inspection instrumentation. Validations (IQ/OQ/PQ) Document drafting, Executions, Summarization / Reporting Manufacturing Equipment Test Method Validations PLC Process Validation of all processes at new facility Facility Validation of new 41,000 sq. ft. building Management (up to 5) External Contractors Personal Staff MBI / UroCor (nuclear medical device implants) Quality and Validations Engineering SPC/SQC and statistical analysis in OQ and PQ phase of validations. Characterization of Semi-automatic See (source) Assembly Machine Training on GMP/QSR, design control, software/computer requirements Quality Assurance / Regulatory Affairs / Documentation Design Control Plan development, execution, and summarization/reporting Internal GMP, QSR and OSHA audits SOP revisions and drafting Project Planning of all Quality Issues using MS Project. Validations (IQ/OQ/PQ) Document drafting, Executions, Summarization / Reporting Manufacturing Equipment Process and Batch Tasks at Oread Pharmaceuticals (contract pharmaceutical manufacturer) Quality and Validations Engineering SPC/SQC and statistical analysis in OQ and PQ phase of validations. Air change Calculations Sampling and AQL development based on ANSI z1.9 and 1.4 Quality Assurance / Regulatory Affairs / Documentation Cleaning Specifications SOP generation SOP revisions and drafting Audits WFI systems Batch Verification Batch Manufacturing Specifications Criteria Generation and associated SOP's Regular Steering Meetings for Validations Coordination Audit Responses to several Clients Stability Trending Validations (IQ/OQ/PQ) Document drafting, Executions, Summarization / Reporting Manufacturing Equipment Process Validation Team IT support Technical Transfer Support Completion of Validations Audit Responses Client Response Relocation Assistance Tasks at Qualisys Diagnostics, Inc. Class II level medical device diagnostics manufacturing facility Quality and Validations Engineering Design of Experiment Product design improvements planning Product and raw material prospective evaluation. Statistical Process Capability (SPC) charting. Statistical Quality Control (SQC) implementation. FMEA, FTA, HA (Failure Modes and Effects Analysis, Fault Tree Analysis, Hazard Analysis) Feasibility and Stability runs using Arhenius equation and 3rd order kinetics. Validations Lab Equipment and production equipment Test Method validations Cleaning Process Validations Validations & Verifications - assisted outside contractors with software validations. Facility Training Training personnel in QSR, cGMP's, GLP, OSHA and ISO9000's Computer applications training. Information and Technical Systems Customized databases for collecting and controlling information from instrumentation, metrology, maintenance, documentation, purchased chemical control, indentured lists, and other controlled systems. All aspects in rolling in new systems and peripherals. All technical support - (hardware and software) Programming (Excel, Access, and VBA related) Troubleshooting Training and assistance Production and Process Engineering Making suggestions for improvement of process. Implementing facility design into projected product production area Challenging designed process plans. Feasibility runs. Documentation (Revision of existing SOP's and generation of new) Incoming Material Inspection Development of database tracking system. Development and implementation of labeling system. Development of QC sampling and testing, stability retention, approval, quarantine, MRB assignment. Purchasing Responsible for tracking and purchasing lab supplies, information, and equipment Responsible for over $750,000 purchased in capital. Budgeting purchases Correspondence with suppliers: VWR, Scientific Products, Fisher, OHAUS, Omega, etc. Inventory Control Quality Assurance Certification of new suppliers/vendors. Purchased Chemical Control Supporting two 510(k) processes and a PMA. CE mark and MDD (Medical Device Directive) support. Industrial Hygiene and Safety: Metrology Corresponding with local contracting agencies in the implementation of calibration system. Assuring NIST traceability is maintained with all applicable instrumentation Exploring cost vs. in house calibration alternatives Implementing Handbook 44 and 130 in calibration procedures. Accounting all equipment is traced and applicable calibration schedule is maintained. Maintenance (preventive and emergency) Creating and implementing of maintenance program for lab equipment and production equipment as they are being acquired. Quality / Validation Engineering - B Braun | McGaw Intravenous Pharmaceuticals & Parenteral Manufacturer * Product complaints investigation - Product Service/Incidence Report (PSR/PIR) * Identifying areas of common product issues and presenting suggestions for product improvement and trend analysis * Validations (Installation, Operational, and Performance Qualification) (see Validations & SubValidations) PLC, systems (retrospective), facilities, equipment and product Protocol generation and execution Coordination of validations with applicable departments Validation summarization Product Test Run Authorization execution and creation of testing method Some - Design of Experiment generation, coordination and execution Statistical evaluation with respect to Cpk, confidence level, military standards, etc. Final deposition of product based upon the statistical evaluation and product performance Quality Control Release Verification (QCRV) coordination Review of Maintenance Orders and assignment of Change Control Validation or QCRV Coordination of sampling plans and required testing with laboratories 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 Addressing problem facilities/systems/products and identifying trends Tracking the maintenance progress and laboratory results Meeting presentations - As Acting Chairperson Product investigation updates and statistical evaluation Validation updates and coordination QCRV / Change Control Request coordination meetings with maintenance department and laboratories SOP generation/revision and Document Orders Revision of Standard Operating Procedures, Technical Information Standards, etc. Creation of quantitative sampling plan with aid of mil. standards or other statistical approach Knowledge of Plastics and LVP fabrication / filling EXCEL®, DUPLEX, PAB®, Glass, PIC, Add-A-Vial®, addEASE*, Compounding, SafeLine®, Injection Molding, Blow Molding, Film Extrusion Technical Training of Personnel Computer training - Windows/NT, Excel, Word, Network (Novell), Lotus Organizer & Notes New Test Methods, Validation, QC Release Verification Technical Assistance Computer, applications, network, printer and other assistance Requalification / Validation approach and procedures Internal Audits (Routine and unscheduled facilities and process audits) Involved with teams, in efforts of modernizing and improving specific aspects of the company LABORATORY McGaw | Braun, Allergan, and Qualisys Chemistry · Infra Red Spectrum analysis - Perkins Elmer (Liquid and Solid) · Gas Chromotography - Hewlette Packard 6890 II · Standards and Sample testing · Obtaining results within a minimum of 99% correlation of obtained Linear Regression · Maintenance of machine, peripherals, computer, printer, gas delivery, headspace, gas tanks · Troubleshooting · Spectrophotometer (UV and visible) · pH analysis (Electronic and Titration method) · Atomic Absorption analysis · FPLC (Pharmacia) / HPLC (familiarity) · Fractionating (Pharmacia) · IMx (Abbott) Spectrophotometry (familiarity) · Immunoassay techniques / Enzyme reactions (manual / robotics - Tecan / Autolucy Anthos Rosys) · EIA and use of software to characterize enzyme activity · Luminescence (Zylux Luminometer system) Biological · Biochemical · Electrophoresis · Western Blotting · Immunoblotting · Microbial · Limulase Amebocyte Lysate (clot) testing of surgical devices · Auxonographic testing of Antibiotic affectivity · Bioburden testing of air water, plastics, surgical devices, and solutions · Filtration and incubated growth on TSA plate · Heat Shock · Inoculating & Enumeration · General biochemical ID techniques Gram Staining, acid-fast stain, OF-Glucose, Oxidase, Catalase, etc. · Surface testing (RODAC and Swab) · Sterilizer use - Castle / Amsco Environmental Monitoring · Particulate Matter monitoring in water and air using HIAC or MetOne · Velocity of air using AIRVELO · Pressure, temperature, and humidity monitoring · HEPA hood leak testing · Data trending · LIMS Engineering · Instron (basics) · Comparitor · Oscilloscopes (various) · Multimeter (Fluke and other) Other (Microcalipers, Tensiometer, Fluid / Air flow meters, Pressure gauges, Filter integrity testers, Radiation Dose Meters, IR thermometers, Thermocouple / RTD, Kaye Validator Digistrip) |
This page was last updated on: August 22, 2001
