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Click here or scroll down to respond to this candidateCandidate's Name
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Email: EMAIL AVAILABLEMobile: PHONE NUMBER AVAILABLE- Fax: PHONE NUMBER AVAILABLEPage 1 of 2Summary of QualificationsTwenty-four (24) years in Biotech industry. Successful experience in Quality Assurance Documentation and Records Management and Training with recognized strengths in planning, prioritizing, organization, time management, handling detail and problem solving.Eighteen (20) years EQMS experienceNine (9) years internal audit experience.Maintain current working knowledge of national and international standards and guidelines; especially how they relate to the practical implementation of Quality Systems.Proficient computer skills: Microsoft Office, WordPerfect, AutoCAD, Visio, Adobe Captivate, Bartender, Global Submit.Conscientious, dependable, flexible, work well under pressure, team player.Work effectively and efficiently with minimal supervision. Ability to train and motivate others. Work ExperienceJuly 2020 - April 2022: Syner-G BioPharma (contract) 2 Park Central Dr Suite, Southborough, MA Quality Assurance Consultant - Organized documents in Excel EDMS for Quality documents to prepare for transfer to an electronic validated EDMS. Assist QA with writing and formatting Quality SOPs. October 2017 December 2023: Flynn Life Sciences - 550 Cochituate Rd, Framingham, MA 01701 contracted with Vedanta Biosciences, 19 Blackstone Street, Cambridge, MA Quality Assurance Consultant Prepared and formatted documents for Veeva Vault QualityDocs implementation. Manage controlled documentation (EQMS) in Veeva Vault QualityDocs. Support Quality systems in Veeva Vault QMS Support management of Training Program. Implemented Iron Mountain for records management. Assist with the day-to-day quality operations as per cGMP, ISO, ICH and FDA guidelines. Write Standard operating procedures (SOPs) and Work Instructions as necessary for documentation and training. Support Manufacturing for QA activities, i.e. PCO (Product Changeover), issue logbooks, assign batch record numbers, issue batch records and production labels, audit binders in suites, QA walkthrough. Assisted in QP and BARDA audits QA Compliance duties as assigned. Create controlled (restricted) Word templates for Clinical use. Assist Clinical with audit vendor organization, electronic filing and paper archive. Assist Regulatory, clinical and program management with coordination and formatting of CMC dossiers, INDs and other regulatory submissions.February 2003 - June 29, 2017 (collective layoff): LFB USA, Inc. (formerly rEVO Biologics and GTC Biotherapeutics) 175 Crossing Blvd., Framingham, MA 01702 Quality Assurance Documentation/Records Manager Part of the implementation team for SmartSolve (EQMS) and responsible for validating the document and training modules. Assist with implementation of SmartSolve (EQMS) for France LFB. Quality Assurance Information Technology (QA/IT} Systems Administrator for SmartSolve QMS for Document Control and Training. Work closely with IT to ensure timely closure of Part 11 related CAPAs and gaps. Work with QA training management team.Candidate's Name
54 Howarth Road, Oxford, MA 01540Email: EMAIL AVAILABLEMobile: PHONE NUMBER AVAILABLE- Fax: PHONE NUMBER AVAILABLEPage 2 of 2 Ensure inclusion of regulated and validated IT systems within LFB USA. Contribute to the coherence, quality and integrity of data owned by users. Report on metrics in SmartSolve EQMS system. Participate in writing and reviewing QA/IT Policies and procedures. Assist customer base with development of meaningful Crystal reports and metrics reporting. Responsible for managing SmartDoc module to meet requirements and compliance for change control and document control. Responsible for troubleshooting with Pilgrim Quality Solutions for technical issues in SmartSolve. Write and update applicable Quality System documents and SmartSolve Work Instructions as needed. Review and Approve Quality Systems documents as needed. Provide training on Quality Systems as needed. Responsible for Quality Management Review Committee (QMRC) metrics for Document Control and Training. Oversee maintenance of CAD Drawings for Document Control in SmartSolve. QA Support for audits and inspections. Other QA Compliance duties as assigned.1999 - 2002: Stryker Biotech, 35 South Street, Hopkinton, MA 01748 Documentation Specialist at Creative Biomolecules (CBM) who merged with Stryker Biotech Instrumental in successful completion of the consistency series and the manufacturing section of Pre-Market Approval document. Received a special monetary award from the Board of Directors for this significant milestone. Maintenance and improvement of document control and records management for quality systems in compliance with company and regulatory policies (paper and electronic). Education Ross University Computer School - New York/ St Kitts, West Indies, Computer processing Certification 3.8 GPA Pilgrim Software -Smartlnsight Bootcamp Training Pilgrim Software - SmartSolve Bootcamp Training for System Administrators American Society for Quality - Member since December 19, 2000, Senior Member since July 9, 2009 American Society for Quality - Quality Auditor Certification Member of Association of Records Managers and Administration (ARMA) Boston Chapter Worcester Polytechnic Institute - Six Sigma Process Improvement Certificate Program Crystal Reports (9.0) Training American Society for Quality- Certified Quality Auditor Review & Test Preparation, (C.E.U, 2.0) Pilgrim Software - Q&MIS (Quality & Management Integrated System) Application Functional Administrator Training for Document, Training, Calibration Modules The Center for Professional Advancement, East Brunswick, NJ, Conducting Effective Quality Audits,(C.E.U.1.2) The Center for Professional Advancement, East Brunswick, NJ, Documentation Management and Control in the Pharmaceutical and Related Industries, (C.E.U.3.0) Personal Accomplishments Volunteer Computer Instructor (Computer basics & Introduction to Microsoft Word) Bethany Hill School, Framingham, MA 01702 Masters Degree Theological Studies (ThM) (August 2016) Parsons Theological Seminary, Brooklyn, MA under the auspices of International Theological Seminary of California. References available upon request |
