Job Title:  Document Control Clerk

Summary:

Responsible for the document control system and functions for individual site facility.

Duties and Responsibilities:

•    Assist the Quality Manager in the continuous improvement, trending, and tracking of the Quality Management System, including the following:
-    CAPA System – Monitor for timely closure and effectiveness.
-    Compliance System – reporting, trending, and tracking.
-    Monitor the Internal Audit program and trend and track data.
•    Participate in Quality Management System Reviews.
•    Participate in 3rd party inspection – FDA, Notified Bodies, and Corporate.
•    Conduct quality system training of personnel in Quality Control and Quality Assurance procedures.
•    Ensure all Quality Management System documents are properly controlled, maintained, and protected.
•    Continuous analysis and improvement of document control protocols, systems, and processes, ensuring both internal and external regulatory requirements are met.
•    Maintain an in-depth working knowledge of ISO and FDA requirements.
•    Responsible for reconciliation and training of document control procedures and practices across functional disciplines.
•    Identify ways to improve and eliminate waste in our transactional procedures.
•    Verify document revision levels.
•    Lead cross-functional teams to complete special projects and support continuous improvement of work instructions and operating procedures.
•    Track departmental metrics and assist with establishment of document control performance metrics.
•    Understand, practice, and enforce corporate policies and procedures.
•    Responsible for archiving and retrieving the Quality System Files as required by the Document Management System.

OCCASIONAL DUTIES:
•    May assist with DMR updates, Work Order packets creation, and other Document Control Clerk activities.
•    Manage direct reports or interns as department needs warrant.
•    Participate in special assignments as requested.
•    Once employee demonstrates competency in position, he/she may be required to train others in similar role.

Education:

High School Diploma or GED required

Experience:

1-3 years in a Manufacturing environment