Document Control Coordinator

The Document Control Coordinator is responsible for accurate, timely review and processing of Document Control Requests (DCR) based on priority. This position will manage all documentation system functions such as administrative roles in our Grand Ave Software for the DCR module, which includes deviations. This position provides documentation support to all site personnel.

Accountabilities & Responsibilities:

• Maintain and support administrative role in Grand Ave Software DCR module
• Support the documentation process by preparing, reviewing, routing and releasing documents used in assembly, and operations, as well as quality system documents and corporate policies
• Expedite document changes to completion and distribution, while ensuring compliance with Quality System procedures and templates where applicable. Support and manage all offsite storage and preparation of boxes to the storage facility
• Support administration tasks in Grand Avenue and coordinating tasks as appropriate
• Support system changes for adding, removing, and updating employees and their access and/or responsibilities
• Facilitate, communicate and manage changes to released documents, with appropriate priority, through internal and external customers
• Analyze change activities to ensure adherence to quality procedures
• Monitor DCR metrics on a routine basis to ensure goals are met
• Support audits of documentation workflow and provide feedback on potential improvements
• Provide support and training on methods, procedures and requirements for the documentation team and site personnel
• Other duties as assigned
  
  

Education & Experience
Required:

• High School Diploma or GED
• 1+ years of experience in documentation/document control
• 1+ years of experience in a medical device or other regulated industry
  
  

Preferred:

• Previous experience working with Grand Avenue, or similar electronic quality system
  Knowledge & Skills
• Demonstrated ability to organize, prioritize, multitask and meet deadlines
• Strong attention to detail
• Knowledge and understanding of release, change request and change implementation processes
• General ability to read and understand a variety of documentation types, such as engineering reports, design specifications, work instructions, etc.
• Proficient in MS Office Products, particularly Word and Excel
• Knowledge of electronic signature platforms such as Adobe Acrobat, DocuSign, or similar
• Excellent verbal and written communication skills with the ability to communicate effectively with individuals of all levels
• Knowledge of medical device regulations (21CFR820, ISO 13485) or another regulated industry