The Document Control Coordinator I sets up and maintains records/data management system to capture all records control requirements, including maintenance of files, quality assurance, information conversions, and systems automation. Develops policies and procedures for records/data management system. Being a Document Control Coordinator I typically reports to a manager. Requires a high school diploma. Being a Document Control Coordinator I works on projects/matters of limited complexity in a support role. Work is closely managed. Working as a Document Control Coordinator I typically requires 0-2 years of related experience.
Document Control Coordinator Job Description Template
Our company is looking for a Document Control Coordinator to join our team.
Responsibilities:
- Act as liaison between authors and approving governance body;
- Ability to work 8-5 pm;
- Ability to work overtime when needed;
- Participates in FDA, Corporate and internal audits and on cross-functional teams;
- Upload study summary documents and update portal trackers with URL link;
- Perform Quality Control (QC) and editing of study documents prior to uploading to the document management system (e.g. EPIC);
- Implementation of documentation and change control using the electronic documentation and change control software;
- Reviews and analyzes proposed changes to controlled documentation;
- Support global and regional document owners with protocol governance submissions to governance committees;
- Prepare quarterly Key Evidence Generation (KEP) report to communicate studies to US Medical;
- Conduct training for new hires study governance process and document submission requirements;
- Work within companies ERP system;
- Review and help edit technical documents;
- Help coordinate any requests from customers;
- Track document milestones and completion.
Requirements:
- Ability to prioritize multiple projects and work independently as well as in a team environment;
- Ability to communicate effectively with all levels of the organization;
- Detail oriented and good communication and interpersonal skills;
- Preferable knowledge of Quality System Requirements (QSR), ISO 13485 and CE regulations and compliance thereof;
- Understanding of documentation system and management;
- Strong attention to detail;
- Experience with an ERP system, such as SAP, Syteline or similar;
- Bachelors’ degree (B.A./B.S.) from four-year college or university preferred;
- Strong ability to work in a self-directed manner while balancing various activities and competing demands;
- Must be able to work within a team environment;
- Ability to multi-task in a fast-paced environment;
- Superior organizational skills. Excellent attention to details;
- Excellent working knowledge of MS Office applications along with some general applications software knowledge;
- 2+ years of experience working with items, BOMs, ECNs and documentation control;
- Able to work under stress and meet deadlines.