Label Specialist – Contract Position – CoWorx Staffing Services

LABEL SPECIALIST – CONTRACT POSITION SUMMARY:

Brief statement summarizing the primary objective or purpose of the position.

* Responsible for Labeling updates for Cardiac Care business unit

* Responsible for procedural updates

* Responsible for coordinating GS1 UDI data submission to regulatory agencies and external stakeholders

PRINCIPAL RESPONSIBILITIES:

Description of major duties and responsibilities of the role.

* Responsible for creating, redlining, review and approval of the label artwork and other labeling documents per company policies and procedures.

* Maintain, catalog, and retain all labeling materials in accordance with company policies, procedures, and technologies.

* Aware of GS1 UDI regulations, Agile PLM and Bartender system for barcode creation.

* Act as a reviewer and signatory during review of labeling ensuring that content complies with regulatory requirements and guidelines and company policies and procedures.

EDUCATION / EXPERIENCE REQUIREMENTS:

Minimum level of education/experience required.

* Bachelor’s Degree with 5+ years of work experience in documentation, labeling or regulatory compliance (a minimum of 1 year in medical device manufacturing)

* Experience in change management systems

* Familiarity with standard concepts, practices, and procedures related to Information Systems

* Effective communication skills with well-developed administrative and technical writing skills

* High creative ability and strong public speaking / facilitator skills

* Team player with the ability to multi-task, prioritize and take initiative in a fast-paced dynamic environment

* Proficient with MS Word, Excel, and PowerPoint

* Demonstrates the ability to perform in a cross functional environment – highly organized and detail oriented

* Has knowledge of commonly-used concepts, practices, and procedures regarding quality system training

* Working knowledge of word processing, spreadsheet and graphics software, including Adobe Creative Suite (InDesign, Illustrator, Frame Maker)

o Ability to convert them to PDF or JPEG files and file and maintain records

* Resourceful, “can do” attitude

PLEASE EMAIL YOUR RESUME TO CHELMSFORDRECRUITING@COWORXSTAFFING.COM

CoWorx Staffing Services

6 Boston Road, Unit 105

Chelmsford, MA 01824

978-677-7595

Equal Opportunity Employer – CoWorx is an equal opportunity employer. We encourage minorities, women, veterans and disabled individuals to apply.

From Greater Lowell Chamber of Commerce

133 Merrimack Street / 2nd Floor
Lowell, MA

Represented by

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