Steven Woolard

*** ******* ***** *******, ** ****2 • 847-***-**** • ac6o98@r.postjobfree.com

Profile:

Highly motivated, results driven Desktop Publisher with 20 years experience and a strong background in visual creativity and design layout. Versatile, quick-learner willing to embrace new challenges. Excellent client/co-worker relationship skills and multi-tasking abilities.

Skills:

•Extensive knowledge of multiple software programs. Adobe CC: Adobe Illustrator, Photoshop,

InDesign, Quark Express, Microsoft Office, Adobe Acrobat Pro DC, Docu-Proof and DocuSign.

•Strong multiple platform abilities - Macintosh and PC.

•Job management, proof reading skills and FDA compliance regarding the Pharmaceutical/Medical

industry as well as EU regulation (ISO 18113-1, 18113-2, IVDD-IVD Directive)

•Experienced Pre-Press operator and full working knowledge of the printing industry.

Skilled Flexography plate maker.

•Ability to work within a team environment as well as able to understand individual goals and

responsibilities. Able to multi-task at high level.

Accomplishments:

•Certified for Baxter Product Life Cycle Management (BPLM) and Team Center United (TCU). (Job

management programs)

•Creation of art department, database for: clients, artwork, and label production with Harbro Packaging

Company.

•Responsible for job scheduling of production, printers and Jr. artists. Managed all three departments at

Harbro Packaging - Art, Pre-Press and Plate making.

•Became Art Director for Harbro Packaging Company.

Professional Experience:

Sysmex-Inostics June 2016 – April 2017

•Prepare and update labels, cartons and instructions for use (IFU) for the IVD and RUO products.

•Assist the management of Safety Data Sheets.

•Assist regulatory submission preparations for new products and product changes as required to ensure

timely approval for market release and in accordance with applicable regulations, standards and

guidance.

•Manage translation companies and local technical reviewers to translate IFU and other regulated

materials.

•Provide guidance and review of product labeling, promotional material, change control and other

related product documentation.

•Maintain regulatory affairs product files to support compliance with requirements and standards. May

generate and support technical files and declarations of conformity.

•Assist with regulatory audits from partners and external regulatory agencies.

•Recommend modification to internal guidelines, work instructions, procedures. Draft Regulatory

procedures.

•Maintain current knowledge of the developments and changes to applicable laws, regulations and

industry standards, and assist in the dissemination of this information to the appropriate individuals

within the company and sector.

Baxter International June 2014 - October 2015

•Label Editing for medical products division. Inserts, labels, IFU’s and instruction manuals for at home

and clinical medical products.

•Responsible for label content, label changes and proof reading. Job management of multiple jobs.

Knowledge and understanding of FDA regulation/compliance. Language translations.

•Worked closely with Content, Quality and Engineer/tech “owners” to implement changes redlining

proofs using Adobe Acrobat.

•Job tracking using Baxter’s BPLM and TCU programs.

•Involved with production meetings with clients, cross-functional teams, work-flow lead and supervisor.

Professional Experience:

Freelance Graphic Designer July 2010 - May 2014

•Strong ability to find new business and to be creative in today’s fast-paced competitive global

environment. Key at understanding customer’s needs. Delivering great design and the ability to

communicate effectively. Logo design, Flyers, Brochures, Menus and more.

Professional Experience:

Harbro Packaging Co. September 1996 - July 2010

Art Director:

•Managed completion of production artwork and design projects and provided technical support for

artwork completion. Oversaw design and conceptual development of creative process with staff artists.

•Strong working relationship with clients, sales and production staff to discuss work load and strategy.

Responsible for daily/weekly job scheduling for artists and printers.

•Closely involved with quality control and press checks. Implemented and created development of art

department at Harbro Packaging Company.

Desktop Publisher:

•Responsible for creating design and label art. Executing label changes as per customer needs and fully

FDA compliant.

•Design projects included: pressure sensitive labels, inserts, logos, catalog and flyers.

•Photo re-touching, color correction and alteration of existing art.

Pre-Press Operator:

•Lead pre-press operator for Harbro Packaging Co. including working knowledge of all

hardware/software.

•Film and plate making for all projects in production. Responsible for job tracking, set-up of all jobs and

purchaser of all supplies in pre-press and print department.

Education: B.A. SCHOOL OF THE ART INSTITUTE OF CHICAGO 1994 - 1996

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