Document Management Specialist
The Document Management Specialist will review all documentation housed within Qualtrax and provide guidance to authors for appropriate document type and structure. Position will be responsible for record archival. Provide support for various documentation initiatives such as QMS (Quality Management System) integration/remediation. They will be expected to comply with, enforce, and be held accountable for all GxP regulations, other regulatory entities governing the company, and all job related procedures.
Interact with all personnel levels and departments to help ensure full compliance with organizational, state, federal and other laws and guidelines as well as internal quality requirements. Reviews documentation submitted into Qualtrax for requirements outlined in the procedure. Provides guidance for documentation authors on appropriate document type and structure. Responsible for maintaining record archive. Complies with established communications code concerning Brooks Life Sciences business and patient confidential information. Works with area management on continuous improvement initiatives with the documentation management field. Performs some clerical duties. Monitor metrics related to documentation. Use available data to discern key quality information Provide support in customer/regulatory audit preparation and documentation Edit/create documentation within the QMS as needed. Cooperates with Brooks Life Sciences staff to achieve goals. Performs other duties as directed.
Academic & Work Experience
Bachelor’s Degree in Life Sciences or equivalent years of related work experience required
1+ years of experience in a GLP/cGMP environment required
Key Skills and Position Competencies
Ability to travel 10%
Proficient in Microsoft Office Suite.
Excellent interpersonal, organizational, oral, and written communication skills.
Strong attention to detail.
Quality Management System (QMS) experience.
Documentation hierarchy experience.