Engineering Change Control/Technical Writer

Terry MacArthur

** ***** ****

Ipswich, MA *****

www.macarthurdesign.com

*****@***************.***

Office - 978-***-****

Cell - 781-***-****

PROFILE

TECHNICAL WRITER/ENGINEERING CHANGE CONTROL

Accomplished Project Manager with expertise in developing, designing and editing SOPs, documents, policies

and procedures, with pharmaceutical and medical device industries. Proven ability to establish/build a well organized productive document control system. Demonstrate 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, coding, validation, compliance and quarantine, all contributing to the resolve of internal and external circumstances.

• Arena: pharmaceutical, medical device, consumer goods

• Organizations: OSHA, ANSI/ISO/ASQC, FDA, Title 21 CFR, ICH, HACCP

• Concentration: R&D, quality assurance, QA validation, SAE, manufacturing, logistics, compliance, vendor/supplier, lot control, shelf life studies, study protocols, comprehensive data analysis

• Scope: develop/design flow charts, SOPs, IND, MRO, MDF, API, cGMP, GxPs, SAE, ECO, QS IEC, ISO Regulations in accordance with FDA regulations

• Project management: managing technical writing projects, developing and implementing SOPs, tracking all approvals, managing Engineering Change Control processes

PROFESSIONAL EXPERIENCE

BOSTON SCIENTIFIC CORPORATION 11/2009-04/2010

TECHNICAL WRITER , ECO (Quality Assurance Group) (Consultant)

Reporting to Quality Sr. Site Manager, writing documents for ETO Sterilization group, managing multiple tasks independently, while developing SOPs and Guidance documents to meet FDA guidelines, while managing Change Control System.

IMMUNOGEN 04/2008-07/2008

TECHNICAL WRITER, (Consultant)

Reporting to QA Manager and Director writing documents for QA Compliance group, managing multiple tasks independently, while developing SOPs and analytical source documents to meet FDA guidelines.

ACUSPHERE 02/2008-04/2008

TECHNICAL WRITER, (Consultant)

Reported to Director of Quality Systems Compliance, reviewed, edited and managed Engineering Change

Control for QA Biennial reviews of Quality SOPs.

BIOVEX INC. 08/2007-02/2008

DOCUMENTATION 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 05/2006-08/2007

TECHNICAL WRITER , ECO (Quality Systems Group) (Consultant)

Managed Engineering Change Control with a concentration on the Validation Group of the Quality Systems Group within Global Distribution Center. Performed according to FDA guidelines, ISO and in response to CAPAs within Quality Compliance Systems. Fully licensed PDM, directing documents through Windchill’s Product Data Management (PDM) system to comply and meet ISO, EH&S and FDA standards and timelines.

WYETH BIOPHARMA 10/2005-01/2006

PROJECT MANAGER, (Documentation/Planning) (Consultant)

Product - rhBMP-2 2x

Researched, 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 PTRs (Plant Trial Runs) and for Commercial productions.

ACUSPHERE 08/2005-09/2005

TECHNICAL WRITER, (Consultant)

Project Manager; redesigned batch record processes for quality assurance and manufacturing converting from clinical trial procedures to commercial production procedures.

HOWARD’S RETAIL (Visual Merchandise) 02/2002-12/2007

CREATIVE CONSULTANT

Creative consultant; business development, researching leads and developing relationships for future sales of visual merchandising packages, for the exterior and interior design industry. Develop and track leads, scheduling follow up calls and visits. Client listing among the corporate sector involves: restaurant industry, retail industry, film and theater, themed events and themed parks.

CAMBRIDGE RESEARCH AND INSTRUMENTATION 03/2001-03/2001

TECHNICAL WRITER, (Project Manager) (Consultant)

Project Manager; developed procedures and flow charts for quality assurance and manufacturing in preparation of ISO qualification, converting procedures from pilot to commercial production.

FORMATECH, INC. 09/2000-11/2000

TECHNICAL WRITER, (Consultant)

Project Manager; 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. 05/2000-09/2000

TECHNICAL WRITER, (Consultant)

Project Manager; wrote SOPs for information systems group, managed multiple tasks independently,

while developing SOPs and analytical source documents to meet FDA guidelines within Title 21 CFR. Systemized an approval tracking system to control various stages of review, with multiple levels of management.

COLLAGENESIS 02/1998-07/1998

TECHNICAL 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) 03/1996-06/1997

PROJECT MANAGER, (Technical Writer) (Consultant)

Managed and developed SOPs, for the distribution of medical devices this included; all support documents,

training documents and job descriptions. Developed procedures standardizing internal activities for marketing,

sales, logistics, purchasing/operations, and external operations with vendors and suppliers.

• Procedures ranged from point of receiving through distribution also FDA regulated recall procedures

• Developed procedures to assure quality control in departmental compliance and vendor compliance

• Established vendor/supplier relationships for preparation of FDA audits

• Implemented cGMP procedures, developed procedures for SAE

• Devised 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, the control of receiving recalled product, and the regard to the isolation of the product

according to FDA guidelines.

• Operations 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.

TIMBERLAND (Corporate) 04/1994-06/1994

VISUAL MERCHANDISE ASSOCIATE

Timberland, redesigned all existing displays corporate board rooms and new retail stores. Created and

assembled apparel displays for marketing trade shows, photographed leather factories and herb farms for

the Natural Elements sales promotion.

THE GILLETTE COMPANY 03/1992-09/1992

QUALITY ENGINEERING, (Consultant)

Planned, scheduled and coordinated the qualification of packaging gages. Worked with vendors/suppliers

at off-site locations, scheduled workloads for technical staff and evaluated data, developed engineering

reports in preparation for presentation.

CORPORATE MAILING SERVICES 12/1991-03/1992

OPERATIONS MANAGER, (Consultant)

Operations manager, scheduled and assigned workload for the assembly of mail kitting, using Admark ink-jet labeling; Cheshire labeling; sorting, folding, Pitney-Bowes; metering and mailing for financial institutions.

THE GILLETTE COMPANY, (Personal Care Division) 09/1971-01/1988

ENGINEERING TECHNICIAN

R&D Personal Care Division, worked on a daily basis in an OSHA controlled environment within R&D engineering, evaluating testing for packaging. Position entailed working with chemists, clinicians, engineers

and management to develop 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 data and

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 - Current

Developed/designed a product line for the home décor market and successfully marketed it throughout the

United States, primarily to second home industries.

Theatre Designer, designing scenery, lighting and props throughout the Boston area, in professional theater

and privately owned theaters

Theatre resume is available upon request.

COMPUTER SKILLS

MS Word Office Suite, Outlook, Excel, PowerPoint, Windchill’s Product Data Management (PDM) Lotus Notes and 123, Corel Draw, , knowledge of HTML, XML, Framemaker, Photoshop &CAD

MANUFACTURING/R&D/CLINICAL

ISO 9000, ISO 9002, GXP, IQ, OQ, PQ, CSV, API, NDA, IND, INE, PMA, BLA, OSHA, ISS, ISE, MRP, WIP, SMI, MES, APICS, MRO, ECO, EH&S

EDUCATION

DESIGN GRADUATE - ART INSTITUTE OF BOSTON 1986

(Major - Graphic Design; Minor - Photography)

North Shore Community College – Art History 1985

National Kitchen & Bath Association Certificate 1989

Airbrush - Montserrat School of Visual Art 1987

North Shore Community College – Chemistry - course work 1975

PROFESSIONAL AFFILIATIONS

Boston Flower Exchange/Horticultural Society

Boston Interior Design Center

Museum of Fine Arts – Boston

Inventors Association of New England

National Kitchen/Bath Association – Certified

Trustees of Reservations - Massachusetts

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