Document Control Specialist

Responsibilities

• Serves as the primary EQMS administrator, responsible for troubleshooting, user support and Jira ticketing management
• Manage Change Order requests for new/revised documentation in Electronic Quality Management System
• Create, review and maintain Quality system documents
• Provides guidance to departments implementing new or updated documentation
• Oversee documentation activities to ensure the accurate implementation and maintenance of Quality System documentation records across all departments and facilities
• Conduct monthly reviews of TAM webpage documents ensuring current revisions are posted for accuracy and compliance
• Facilitate periodic review of controlled documents to ensure content is current and up to date with current processes
• Perform closure and proper filing of Quality Event records, such as Nonconformances and Deviations
• Initiate monthly review of regulations and standards in the external Document Management System
• Maintain the US GS1 database and oversee UDI code assignment
• Serves as a backup administrator for EQMS training activities such as employee set up and onboarding, managing training profiles, updating or issuing new training requirements, trending, and weekly reporting
• Cook Management Reviews and Internal Audits
• Aid in Validation of Software to support QA activities
• Support and participate in other QA projects and activities as needed

Qualifications/Requirements

• Bachelor’s degree in Life Sciences or Biology, English or Communications, or related field, from an accredited college or university preferred.
• At least three (3) years of experience in medical device industry or a regulated manufacturing environment or related field required.
• Clearance of favorable background investigation required.