Sr Document Control Specialist

Purpose

The Sr. Document Control Specialist is responsible for the maintenance and update of the Quality System documentation records and files maintained in both internal controlled document locations and in the Electronic Quality Management System (EQMS). This position coordinates the activities of personnel engaged in preparing controlled documentation, files, folders and reports, ensuring their completeness and accuracy and providing input regarding modification, revision and resubmission. Support activities related to the management of documentation archives. This position assists in the management of training requirements of employees in the EQMS. This role is responsible for ensuring the training systems are maintained, that personnel training is performed, and that records are complete and up-to-date.

Responsibilities

• 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/update Quality system Documentation as needed. Support other departments in the implementation of new Quality System 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 Events records, such as Nonconformances and Deviations
• Initiate monthly review of regulations and standards in the external Document Management System
• Responsible for managing the US GS1 database and UDI code assignment
• Back up for EQMS training activities such as employee set up and onboarding, managing training profiles, updating or issuing new training requirements, trending, and weekly reporting
• Provide assistance for Management Reviews and Internal Audits
• Assist in Validation of Software to support QA activities
• Support and participate in other QA projects and activities as needed
• Other duties as assigned

Skills

• Ability to work independently and in a team environment
• Excellent attention to detail and organization
• Excellent written and verbal communication
• Strong computer skills and proficiency in Microsoft Office
• Highest level of ethics and integrity
• Ability to lead and motivate the right behaviors
• Ability to multi-task and work in a fast-paced environment

Qualifications/Requirements

• Bachelor’s Degree in Life Sciences or Biology, English or Communications, or related field
• Five (5) years’ of experience working in medical device field or quality manufacturing environment or combine
• Strong writing skills, with a preference in technical writing preferred
• Effective communication skills
• Capable of multi-tasking and working collaboratively with cross-functional teams
• Quick learner, self-motivated with strong organization skills
• Clearance of favorable background investigation required