Quality Engineer

Posted on: 2006-01-06

Summary Eight years experience in Quality Assurance. Demonstrated track record of being a self motivator and ability to learn new technology when presented. Strengths include coordinating 21CFR11 Risk Management and Assessment, GAP Analysis, Master Validation, Documentation Processes/Controls and Standard Operating Procedures. Expertise in developing, writing, and presenting technical documents, validations, SOPs. Trained in cGMP, GLP, EU, MDD and ISO. Major Accomplishments • Instrumental in planning 21 CFR part 11 implementation and executing innovative strategies to achieve regulatory computer system standards for infrastructure improvement. • Researched, negotiated, and instituted standard computer configuration for remote manufacturing instruments, achieving 98.67% project savings from previous estimates, while establishing a multifunctional vendor contact. • Met with vendors and contractors to determine scope of project and analyze current systems and procedures. • Designed, planned and implemented an informational training database application for various company departments for use of various staff members, supervisors and managers in order to assure accurate records of training executions and to ensure the use of most current SOPs. • Implemented a relational database system to maintain inventory records for hardware and software, ensuring software license compliance for all installations. • Researched, redesigned and implemented CAPA procedure and database program for compliance with 21CFRpart11 Business Experience ETEX Corp. Quality Engineer Contractor 11/2005 to 2/2006 Cambridge, MA • Maintain product Quality Plans including sampling plans, product performance and acceptance testing methods. • Manage Risk Management activities for existing products a.) Prepare & maintain formal risk assessment documents b.) Identify & implement risk reduction activities c.) Evaluate the impact of design / process changes to existing risk assessment d.) Assess feedback information for impact to risk management strategies. • Maintain Validation Master Plans – write and execute validation protocols; compile & analyze data using statistical methods and generate written validation reports. • Identify and assist with the implementation and maintenance of process monitoring applications • Participate in continuous improvement efforts to ensure that manufacturing processes are functioning within established standards etc. • Provide QA oversight for the specification and use of statistical sampling plans. • Performs periodic formal review of sampling plan suitability. • Ensure that policies and practices associated with quality systems are compliant with applicable regulations and standards e.g. QSR and ISO Hyaluron, Contract Manufacturing QA Batch Record Specialist Consultant 9/2005 to 10/2005 Burlington, MA • Batch record review, processing and disposition; maintenance of historical files for all batched manufactured. • Processing. Tracking, and trending departures (deviations, out of specifications, non-conforming material, and complaints); maintenance of historical files for departures and associated trending. • Processing, tracking, and trending corrective and preventive actions; maintenance of historical files and associated trending. • Reporting to management on all departures, and corrective and preventive actions; maintenance of historical files. • Review of validation and stability studies; maintenance of historical files. • Review of Quality Control data associated with batch records, validations, and stability studies. Avant Immunutherapeutics, Inc Doc/IT Analyst 9/2004 to 4/2005 Fall River, MA • Analyzed, defined, set up and documented computer functionality; this included manufacturing, QA and network software and its operations. • Conducted computer application system assessments to indicate areas of improvement or problems; this included manufacturing, QA and network software and its operations. • GAP Analysis and Risk Assessment drafting, executing and documenting • Computer master validation plan drafting and implementation • Development and implementation of 21CFRpart 11 documentation processes/controls • Validation of CPU’s, PLC’s and Off the Shelf Software • Worked with QA and Agilent software and computer hardware to ensure compliance and validation was met. • Development of corporate computer ethic policies/documentation as well as the documentation and execution of Backup/Recovery Contingency Planning • Drafted and ensured compliance of URS, IQ, OQ, PQ and FAT documents for laboratory computer systems • Worked with Finance to ensure proper compliance and documentation for Sarbanes-Oxley • Responsible Avaya phone systems - Network and Phone wiring and hardware installation (i.e. cat6, RJ11/RJ45, data/teleport connectivity testing and connecting) Entrepreneur 8/2002 to 9/2004 DeLugh Malden, MA • Web graphics and designing • Graphic development of Marketing inserts, leaflets, banner and color/black and white ads • Logo design or improvement • Internet security assessment • Web hosting and email setup • Site submission Chemic Laboratories IT Documentation/Compliance/DBA 11/2003 to 3/2004 Canton, MA • Project leader of 21CFR11 documentation and implementation of processes/controls for IT • Development of documentation and implementation of GAP analysis and Risk Assessment and development of Master Validation/Computer Validation Plan • Development of documentation and maintaining URS, IQ, OQ, PQ for laboratory computers • Worked with chemists to setup and mix proper reagents for HPLC runs, using Chemstation. • Calibration of pipette’s and sample set ups for various equipment testing; HPLC, GC, UV-Vis, and FTIR> • Maintained/developed company database • Drafted and updated standard operating procedures • Maintained documentation for monitoring laboratory and desktop/office computer systems, as well as equipment/assets inventory control • IT/Network and desktop/printers support. This included Network and Phone wiring and hardware installation of cat5e cable, RJ45, data/tel port connectivity testing and connecting) QA Doc Auditor/Analyst II and DBA 8/2002 to 11/2003 • Daily auditing of reports (editing errors, chromatograph consistency, formulation errors, pagination) • Documenting, inspecting, and reporting on quality functions • Development, support and documentation for industrial label maker (used for medical devices, vials, etc.) • Finalize documentation of final reports based on audited and approved data • Drafted SOPs, DCRs, Deviations and Change Controls • Maintaining and updating company database for raw materials • Created and Audited Maintenance logs of various pieces of equipment • Conducted calibration and audits of in house pipettes, validation weights and maintenance logs Lonza Biologics QA Raw Materials/Doc Support Analyst 6/2000 to 8/2002 Portsmouth, NH • Designed and maintained central documentation training management database system (also for other departments i.e. Materials Management, Documentation and Compliance) • Implementation/drafting of DCRs and Change Controls for Raw Materials Group • Developed effective electronic workflow of data generated using Excel and Access • Updating/auditing SAP/3 database • Updating/drafting standard operating procedures, as well as the generation and updating of material specifications • Audited, Filed and processed raw materials groups completed test forms and results • cGMP, ISO 9000 and GLP trained • Member of the Materials Review Board Highliner Foods Quality Assurance Inspector 7/1996 to 3/2000 Portsmouth, NH • Inspection of all incoming raw materials • Implementing and development of access database • Developing standard operating procedures, DCRs and Deviations • Participation/involvement with logistics and establishing mock recalls • Ensuring suppliers/vendors are within FDA and HAACP regulations Floor Supervisor 12/1991 to 7/1996 • Supervised crew 6-9 people • Working knowledge of plant processing machinery • Product knowledge (e.g., Yields, Viscosity, etc*) Relevant Skills • Project Design, Scope, Management & Rollout • Risk Management • Risk Procedure Evaluation and Development • Disaster Recovery • Quality Assurance • Life Cycle Management • System Disaster Recovery • Problem Identification & Resolution • Change Management and Process Improvements • CAPA and QMS procedures and training Training • Electronic Regulatory Submissions to FDA – an overview, NERCSQA, Sturbridge, MA, 2005 to 2005 • E-Signature (e-sig) Systems for Control Documents: Using Part 11 to Benefit Your SOP System, NERCSQA, Sturbridge, MA, 2005 to 2005 • Archiving Design and General Archiving Issues, NERCSQA, Sturbridge, MA, 2005 to 2005 • Proficy iHistorian Development, GE Fanuc Automation, Plymouth, MA, 2005 to 2005 • Current FDA Activities around Validation/Data Security, NERCSQA, East Hartford, CT, 2003 to 2003 • Current FDA Computer Validation Activities Including the New Part 11 Document, NERCSQA, Hartford, CT, 2003 to 2003 • Data Security Including Network Security, Backups, Archiving and Contingency Planning, NERCSQA, East Hartford, CT, 2003 to 2003 • Windows Sever 2000, New Horizons, Burlington, MA, 2002 to 2002 • FDA Training on 21CFR part 11, NERCSQA, 2002 to 2002 • Bioethics in Corporate Context, NERCSQA, Waltham, MA, 2002 to 2002 • Ethics, Training, Fraud Prevention and Detection, NERCSQA, Waltham, MA, 2002 to 2002 • Computer Applications, UNH, Durham, NH, 1999 to 1999 • Management Workshop, ML Hanney, Inc, Portsmouth, NH, 1999 to 1999 Education 2000 - Current University of New Hampshire Durham, NH Computer, Business 1998 MacIntosh Dover, NH Computer Science Affiliations • Member, New England Regional Chapter Society for Quality Assurance, 2001 to 2006 • Member, Society of Quality Assurance, 2002 to 2003 ADDITIONAL SKILLS • Microsoft Project xp • Microsoft Visio xp • Microsoft Office xp • Microsoft SQL • XML • Win NT,2000 Server • JDE AS/400 • SAP/3 • Paragon • iFix • iHistorian • Veritas • Exchange Server • SnagIt • Siemes PLC • Avaya • Microsoft FrontPage & PhotoDraw • Adobe Acrobat, Illustrator, Photoshop • Site Submission Applications • Lotus Pro/123 • Flash/MX