Document Control Specialist

Bachelor’s Degree with a minimum of 5 years relevant experience or Associate Degree with 5+ years’ experience preferred Two or more years of document control experience in a regulated industry as a minimum Strong computer skills, including the use of Microsoft Office applications Good grammar and spelling skills Technical writing experience preferred Experience using an electronic Quality Management System preferred Experience in a clinical testing laboratory environment performing document control duties Subject matter expert to train others on document control duties and other eQMS functions Familiar with CLIA, CAP, New York, and/or FDA/IVD requirements Detail oriented, strong written and verbal communication skills Ability to take initiative and prioritize tasks Good time-management, problem prevention, and problem-solving skills Ability to work independently, within prescribed guidelines, or as a team member

Administer the organization’s electronic eQMS systems (MediaLab and Simploud). Manage eQMS user profiles and training matrices. Support all activities related to Document Control in CLIA Laboratories. Manage document life cycle- number assignment, creation or editing of the document, routing, supporting document creation, and document retirement. Manage record retention per company policies. Maintain quality metrics and KPIs; prepare management reports. Train staff members in the use of the eQMS systems. Participate in internal audits to ensure processes comply with established procedures. Support audits by external parties.