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.