Position Summary:

The Document Control Clerk is responsible for the identification, storage, security, integrity, retrieval, retention and disposition of quality records.  The Document Control Clerk ensures that documentation meets all relevant regulating agency’s standards.

DUTIES/RESPONSIBILITIES:

• Maintain hard copy and electronic quality records within a GxP System
• Scan completed quality records with due diligence
• Verify the accuracy and legibility of scanned documents and upload to network folders
• Identify incomplete and/or inaccurate records
• Create inventories of quality records
• Assign the appropriate retention time for each record type
• Maintain a master inventory list
• Prepare, send and retrieve documents to and from off-site archival storage upon request
• Work with cross-functional teams to identify, file, organize and archive documents
• Ensure that records are and remain legible, readily identifiable and retrievable
• Apply Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) to daily tasks
• Work on assigned projects as needed

EDUCATION AND EXPERIENCE:

• High School diploma or GED.
• At least 1 year of experience in a GMP environment.
• Detail-oriented with good organization skills
• Computer literacy required; knowledge of the Microsoft Office suite
• Ability to work with minimal supervision; also be able to work as part of a team
• Good written and verbal communication skills
• Knowledge GDP and GMP desired

PERFORMANCE INDICATORS:

• Accuracy and completeness of records
• Work with minimal supervision; must also be able to work as part of a team
• Ability to use independent judgement as experience grows