Document Control Specialist

Document Control Specialist

The Document Control Specialist is responsible for administering, maintaining, and updating the Quality System documentation records and files maintained in both internal controlled document locations and in the Electronic Quality Management System (EQMS). This position oversees 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 overseeing and administrating employee training requirements within 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:

• 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
• Coordinate and execute 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
• Maintain a working knowledge of FDA 21 CFR 820, ISO 13485, ISO Standards, cGMP/cGTP, FDA 21 CFR 1271, AATB standards, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes
• Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
• Perform 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
• 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
• Self-motivated with strong organization skills and ability to adhere to due dates/timelines
• Strong technical writing
• Proficiency in Microsoft Office

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.