Technical Document Control Coordinator

Job Description

Job Summary:

• As a Technical Documentation Coordinator Contractor, you will, create, format, and coordinate the approval and implementation of labeling documents and reagent and consumable instructions for use documents.

Duties and Responsibilities:

• Editing and proofing of English and multilingual Reagent IFU documents.
• Ensure reagent and instrument labeling documents are created, updated and in compliance with company standards, ISO and GMP as required
• Creation and maintenance of documentation and illustrations that are used by analytical systems
• Creation and revision of product labels using Adobe Illustrator or similar graphic tools.
• Implementation of Design Changes to labeling; release change in compliance with company standards
• Work with multifunctional teams including Regulatory Affairs, Technical Support and Manufacturing to complete day to day activities.
• Query business systems for company information to complete the project documentation
• Follow company process and procedures to schedule and project from draft through approval and release.
• Participates in team meetings

Education and Experience:

• Bachelor’s Degree preferred with 0-2 years of experience.
• Knowledge/Experience of medical device quality systems include FDA, GMP & ISO preferred.
• Experience working with labels and multilingual documents.
• Experience working in a fast-paced environment.

Knowledge, Skills and Abilities:

• Proficient in Microsoft Office applications, Adobe Acrobat and other design tools such as Adobe Illustrator and Adobe Photoshop.
• Demonstrated ability to operate independently, with initiative and good business judgment.
• Excellent verbal and written communication skills including grammar.
• Excellent organizational and follow-up skills, as well as great attention to detail.
• Desire to work independently with minimum supervision.
• Can work and communicate effectively with a variety of people and across functional groups.
• Knowledge computer systems used in product development and manufacturing.
• Ability to coordinate project activities with multiple groups and individuals.
• Prioritize tasks and resolve routine issues.