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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Essex RoadHome Office PHONE NUMBER AVAILABLEIpswich, MA Street Address
Cell - PHONE NUMBER AVAILABLEwww.macarthurdesign.comEMAIL AVAILABLEhttp://LINKEDIN LINK AVAILABLEPROFILETECHNICAL WRITER/ENGINEERING CHANGE CONTROL/ DATA MANAGEMENTAccomplished Technical Writer/Project Manager with expertise in developing, designing and editing SOPs, documents, policies and procedures, with Life Science/Medical Device industries. Proven abilityto establish/build a well-organized productive document control system. Demonstrated success with the design and implementation of Lot Control systems for the distribution of medical devices. In-depth understanding of R&D, QA/QC, Labeling, Validation, Compliance and Remediation, all contributing to the resolve of internal and external circumstances.Arena: Pharmaceutical, Biotech, Medical Device, Consumer GoodsOrganizations: OSHA, ANSI/ISO/ASQC, FDA, Title 21 CFR, ICH, HACCPConcentration: R&D, Quality Assurance, QA Validation, Remediation, SAE, Manufacturing, Logistics, Distribution, Plastics, Packaging, Compliance, Vendor/Supplier, Lot Control, Shelf Life Studies, Protocols Comprehensive Data Analysis, Fixtures and Electronic DevicesScope: Develop/design flow charts, ECN, ECC, ECO, SOPs, IND, MRO, CMO, CLIA, MDF, API, cGMP, GXPs, SAE, ECO, QS IEC, ISO IQ, OQ, PQ, GAMP, in accordance with FDAProject management: managing technical writing projects, developing and implementingSOPs, tracking all approvals, managing Engineering Change Control processesPROFESSIONAL EXPERIENCEMICROCHIP BEVERLY, MA FULL TIME 06/2022-09/2022QUALITY DOCUMENT CONTROL ANALYSTManaged Documentation Change Control process under the guidance of the Quality group; servicing all aspects of Microchips needs.ABBOTT MEDICAL Select Source Intl. - (Project Oriented) 09/2019-08/2020ENGINEERING CHANGE CONTROL (ECC) MANAGER - (Consultant)Reporting to R&D Management, managed Windchill PDM Engineering product, by controlling documentation in an effort to remain current/cohesive within FDA guidelines. While reporting to R&D Manager my assignments were with Quality Validation Group as well. Managed Engineering Change Control (ECC) with a concentration on the Software Processes of Quality Systems within Abbott Vascular, Westford. Performed activities according to FDA guidelines, ISO and in response to CAPAs within Quality Compliance.PHARMACEUTICAL CMO Kelly Services, - (Project Oriented)TECHNICAL WRITER, - (Consultant) 08/2018-09/2018Reported to Manager of Technical Writing Service Group, R&D Quality Operations; regarding the development of Batch Records. Supported all documentation efforts in the transition and harmonization of products for CMO Quality Operations.PHARMACEUTICAL BIOGEN Signature Consultants - (Project Oriented)TECHNICAL WRITER, - (Consultant) 01/2018-07/2018 Reported to Consulting Solutions Director of Biogen Cloud IT team; wrote documents to bring Quality IT into a Biogen Cloud mode with Amazon Web Services (AWS) while executing according to plan, supporting IT, Quality and Regulatory Affairs.PHARMACEUTICAL Black Diamond KA - (Project Oriented) 09/2017-11/2017TECHNICAL WRITER, - (Consultant)Reported to Associate Director of QA, researched document issues with RA Directors, developeda plan of execution according to allotted timeframe brought all documents to working order.PHARMACEUTICAL Fountain Group SH - (Project Oriented) 05/2017-07/2017TECHNICAL WRITER, - (Consultant)Reported to Head, PD Lifecycle, R&D Quality Operations; developed/designed documentation for Global Regulatory Affairs and Drug Safety. Supported all documentation efforts in the transition/harmonization of acquired company documents into current Shire Quality Operations.EMD MILLIPORE/SIGMA ALDRICH - (Project Oriented) 12/2015-12/2016TECHNICAL WRITER, (Consultant)Reported to Principal Process Engineer/Manager; developed/designed documentation for Engineering Services within multiple product lines. Experience in a series of purification filtration documents for Clarification, Cation/Anion, TFF, Ultrafiltration and Diafiltration purposes. Supported all R&D documentation efforts including; URS, FAT, all Validation and Verification activities with IQ, OQ, and PQ these include new/released versions, followed all documents through to electronic distribution.HOLOGIC - (Project Oriented) 07/2015-09/2015TECHNICAL WRITER, (Consultant)Reported to R&D Project Manager; developed support documentation and coordinate project through to final disposition and electronic distribution. Supported all R&D documentation efforts through validation and verification new/released versions.WEST PHARMACEUTICALS - (Project Oriented) 07/2014-07/2014TECHNICAL WRITER, (Consultant)Reported to Program Management within a global contract manufacturing solutions provider and served the pharmaceutical, medical and consumer industries, as Technical Writer for custom specific programs, developed and edited IQ,OQ and PQ protocols, generated validation protocol, coordination and execution of the protocol, along with generated summary reports while ensuring that validation project schedules and project commitments are met.BRISTOL-MYERS SQUIBB - (Project Oriented) 12/2013-01/2014QUALITY ASSURANCE, (Consultant)Reported to QA Engineer of Quality team; responsibilities were Records Archival Reconciliation, proofreading of SOPs and Technical Writing.GENZYME/SANOFI Allston, MA - (Project Oriented) 05/2012-07/2012TECHNICAL WRITER, - (Consultant)Reported to Project Manager of Disposable Buffers Prep Team; developed Principal ProtocolStandard Operating Procedures (SOPs) for all phases of the manufacture of product into aRe-purposed Suite. Designed/formatted documents with Subject Matter Experts (SMEs) of the Manufacturing Technical Services team.HOSPIRA- Rocky Mount, NC - (Project Oriented) 03/2012-04/2012INVESTIGATIONAL REPORT WRITER, - (Consultant)Reported to 3rd Party contractor; worked within Low Volume Solutions (LVS) area within Hospira. Investigated/wrote reports on events in manufacturing. Reports identified current findingsoffering CAPA solutions.EMD MILLIPORE R&D - (Project Oriented) 10/2011-01/2012TECHNICAL WRITER, - (Consultant)Reported to Down Stream Process (DSP) Technical Consultant; developed/designed and formatted,a series of purification/filtration protocols for Clarification, Cation/Anion, TFF, and Ultrafiltration/Diafiltration, to process monoclonal antibodies for clients in the Pharmaceutical and Biotechnology industries. Along with the Bioscience Engineers, derived processes from a master document creating 15 protocols, finalizing and approving them for use in Marketing for the Mobius product. Interactions: R&D, Process Development, Marketing, MarCom, Project Management and Information Systems.BOSTON SCIENTIFIC CORPORATION - (Project Oriented) 11/2009-04/2010TECHNICAL WRITER / ECO, - (Quality Assurance Group)Reported to Quality Sr. Site Manager; developed documents for ETO Sterilization group in a Remediation Process mode, managed multiple tasks independently, while developing SOPs andGuidance documents to meet FDA guidelines.IMMUNOGEN - (Project Oriented) 04/2008-07/2008TECHNICAL WRITER, - (Consultant)Reported to QA Manager and Sr. Director; wrote documents for QA Compliance group, managedmultiple tasks independently, while developing SOPs and analytical source documents to meet FDA guidelines.ACUSPHERE - (Project Oriented) 02/2008-04/2008TECHNICAL WRITER, - (Consultant)Reported to Director of Quality Systems Compliance; reviewed, edited, formatted and manageddocuments for Engineering Change Control along with QA Biennial reviews of Quality SOPs.BIOVEX/AMGEN - (Project Oriented) 08/2007-02/2008DOCUMENTATION CONTROL, - (Supervisor)Reported to Vice President of QA group; identified documentation control needs for start-up phase of manufacturing in a biotech atmosphere. Developed plan for review process, implemented and operated review system as designed and embellished to fit company needs. Established presentation materials for meetings. Investigated new electronic systems with UK and US sites. Roll out a plan to bring documentation system to electronic stage. Supervised QA Document Control Specialist and QA Compliance Associate in daily activities.BOSTON SCIENTIFIC CORPORATION - (Project Oriented) 05/2006-08/2007ECO/TECHNICAL WRITER, - (Quality Systems Group) (Consultant)Reporting to Quality Management, managed Windchill PDM Engineering product, by controlling documentation in an effort to remain current/cohesive within FDA guidelines.WYETH BIOPHARMA - (Project Oriented) 10/2005-01/2006PROJECT MANAGER, - (Documentation/Planning) (Consultant)Product - rhBMP-2 2xResearched, designed, developed documentation information plan. Attended daily Drug Substance Task force, Technology Transfer Team, and Engineering /Validation meetings gathering information and dates for the scheduling of SOPs and Validation execution. Processes developed for Plant Trial Runs (PTRs) and Commercial productions.ACUSPHERE - (Project Oriented) 08/2005-09/2005TECHNICAL WRITER, - (Consultant)Redesigned batch record processes for quality assurance and manufacturing converting from clinicaltrial procedures to commercial production procedures.CAMBRIDGE RESEARCH & INSTRUMENTATION - (Project Oriented) 03/2001-03/2001TECHNICAL WRITER, - (Consultant)Developed procedures and flow charts for quality assurance and manufacturing in preparation of ISO qualification, converting procedures from pilot to commercial production.FORMATECH, INC.- (Project Oriented) 09/2000-11/2000TECHNICAL WRITER, - (Consultant)Developed SOPs, analytical source documents and flow charts for incoming raw chemicals with quality management in accordance to FDA guidelines. Mapped the flow of processes, ranging from the receipt of product, (raw materials) to the products final disposition. Developed and converted flowcharts to SOPs. Validated systems and instrumentation in preparation for vendor audits with prospective vendors/suppliers.VERTEX PHARMACEUTICALS INC. - (Project Oriented) 05/2000-09/2000TECHNICAL WRITER, - (Consultant)Developed SOPs for information systems group, managed multiple tasks independently, while developed/formatted SOPs and analytical source documents to meet FDA guidelines within Title 21 CFR, in preparation for (Disaster Recovery). Systemized an approval tracking system to control various stages of review, with multiple levels of management.COLLAGENESIS - (Project Oriented) 02/1998-07/1998TECHNICAL EDITOR, - (Consultant)Technical editor, edited documents and controlled documents for all aspects of the quality assurance group and manufacturing. Documents were written in accordance with FDA guidelines and designed in ISO format.THE GILLETTE COMPANY (Braun) - (Project Oriented) 03/1996-06/1997(Technical Writer) (FDA-Quality Consultant)Managed and developed SOPs, for the distribution of medical devices this included; all support documents, training documents and job descriptions. Developed/designed procedures standardizing formats for internal activities for marketing, sales, logistics, purchasing/operations, and externaloperations, with vendors and suppliers.THE GILLETTE COMPANY (Braun) - (Continued) 03/1996-06/1997Procedures ranged from point of receiving through distribution followed by FDA regulatedrecall procedures in preparation of Remediation Process (Disaster Recovery) mode.Developed procedures to assure quality control in departmental compliance and vendor complianceEstablished vendor/supplier relationships for preparation of FDA auditsImplemented cGMP procedures, developed procedures for SAEDevised a lot control system controlling product storage through all phases to end user. The lot control system controlled; the delivery of the product to vendor, the labeling/palletizing of, the isolated storage of, and all activities during post-production including the return of suspect product.Established and implemented a procedure to control the recall of the product, recording any SAE, activities from the receipt of call to the end-user, the coordination of audit team, alerting the Warehouse, to control recalled product according to FDA guidelines.Operati ons group, in the area of purchasing, scheduled promotional display packaging productions, assignments were to plan/implement production schedules, with the distribution teams for all promotional activities including; marketing, sales, advertising, public relations, trade shows and special events, worked within internal budgets, quoting and pricing components with suppliers and vendors. Processed training materials according to FDA guidelines, Product Data Manager (PDM).TIMBERLAND (Corporate) - (Project Oriented) 04/1994-06/1994VISUAL MERCHANDISE ASSOCIATETimberland, redesigned all existing displays corporate board rooms and new retail stores. Created andassembled apparel displays for marketing trade shows, photographed leather factories and herb farms.THE GILLETTE COMPANY 03/1992-09/1992QUALITY ENGINEERING, - (Project Oriented)Planned, scheduled and coordinated the qualification of packaging gages. Worked with vendors and suppliers at off-site locations, scheduled workloads for technical staff and evaluated data, developed engineering reports in preparation for presentation.CORPORATE MAILING SERVICES - (Project Oriented) 12/1991-03/1992OPERATIONS MANAGER, - (Consultant)Operations manager, scheduled and assigned workload for the assembly of mail kitting, using Admarkink-jet labeling; Cheshire labeling; sorting, folding, Pitney-Bowes; metering and mailing for financial institutions.THE GILLETTE COMPANY, - (Personal Care Division) (Full-Time) 09/1971-01/1988ENGINEERING TECHNICIANR&D Personal Care Division, worked in an OSHA controlled environment within R&D engineering, evaluated testing for packaging. Position entailed working with Chemists, Clinicians, Engineersand Management to develop SOP standard operating procedures, to assure compliance of research, while controlling consistency to assure product integrity.Evaluated test product packs ranging from packaging performance and shelf-life studies to product delivery in accordance to National Bureau Standards.Performed and presented comprehensive data analysis on Personal Care product test packs.Prioritized schedules and assignments engineering project requests.Programmed and implemented computer systems using Lotus 123 to calculate laboratory dataand report testing results.Developed flow charts, technical and training procedures for all product lines.Designed, implemented and maintained inventory control system for packaging components.Prepared test products for Analytical and Clinical Teams, working directly with engineers, chemists, packaging management, pilot labs, QA/QC and manufacturing.MacARTHUR DESIGN (Principal)1977 - CurrentDeveloped/designed a product line for the home dcor market. Successfully marketed productin the United States mostly in the second home industries.Theater Designer - designed scenery, lighting and props throughout the Boston area, in professionaltheater and privately owned theaters. Theater resume is available upon request.COMPUTER SKILLSMS Word Office Suite, 2007 Outlook, Excel, PowerPoint, Visio, ManGo, SharePoint, WindchillsProduct Data Management (PDM) full license, Agile/Oracle Lotus Notes and Lotus 123,Corel Draw, *knowledge of: HTML, XML, InDesign, FrameMaker, Photoshop &CAD/SolidworksMANUFACTURING / R&D / QUALITY / IT / VALIDATIONFDA, ISO 9000, ISO 9002, OSHA, ICH, GXP, IQ, OQ, PQ, CSV, API, NDA, IND, INE, PMA, BLA, ISS, ISE, MRP, WIP, JIT, SMI, MES, APICS, MRO, ECO, EH&SEDUCATIONDESIGN GRADUATE Lesley University/Art Institute of Boston 1986(Major - Graphic Design; Minor - Photography)North Shore Community College Psychology, Math, Algebra, Chemistry 1973-1985Montserrat School of Visual Art Air Brush Design 1987National Kitchen & Bath Association, NKBA Certificate 1989PROFESSIONAL AFFILIATIONShttp://LINKEDIN LINK AVAILABLEInventors Association of New EnglandBoston Flower Exchange/Horticultural SocietyMuseum of Fine Arts BostonBoston Interior Design CenterNational Kitchen/Bath Association CertifiedTrustees of Reservations - Massachusetts |
