Document Management Clerk

LocationBrookfield, Connecticut
Reports ToDocument Management Team Lead
Position Overview

Document Management Clerk will report directly to the Document Management Team Lead.  The specialist is responsible for supporting the Quality Management System by ensuring compliance with established procedures and quality/business requirements.  The specialist is responsible for supporting the Business Management System by ensuring Production is supplied with accurate labels and documentation required to fill products in a timely fashion.

Duties & Responsibilities
  • Deviations
    • Process company-wide deviations by logging, following up, seeking management approval, following up on any corrective actions needed, and closing out. Participate in root cause analysis and corrective action development as needed
  • Change Controls
    • Maintain the change control process by processing document changes, processing and auditing new product set ups and processing and auditing private & customer labels
  • Document Management – Batch Records, Labels, Supporting Documentation
    • Print and audit batch records, labels and other required documentation in accordance with production schedule, tank list and established procedures
      Control and issue batch records and labels in accordance with established procedures
      Support Production needs by printing additional labels/documents and reconciling additional labels
      Proactively communicate label stock inventory concerns to DMS Lead and Supply Chain
  • Document Archive/Management
    • Ensure controlled documents are properly filed, archived and maintained in accordance with ISO and GMP requirements
      • Includes Quality Control Product Files, Batch Production Record packets and other quality documents
    • Retrieve archived documentation in a timely fashion
  • Printer Hardware Maintenance
    • Be familiar with label printers and understand the basic mechanisms of the hardware
    • Maintain the printers through regular cleanings
  • Visual Aid Audit
    • Verify corporate compliance with Visual Aid program through the Visual Aid Audit twice a year
  • Triennial Documentation Review
    • Assist in the yearly triennial review of documents
  • CoA Issuance
    • Fulfill CoA requests via Shipping requests and Pharmco CoA Email Inbox to ensure CoA’s are provided for external warehouse shipments and other customer inquiries in a timely fashion.
  • Manage and execute any assigned projects needed to support business growth
Skills & Qualifications
  • Strong communication and interpersonal skills
  • Proven work experience and qualifications as a collaborative and agile team member
  • Strong organization and time-management skills
  • Proven ability to multi-task and balance speed with accuracy
  • Ability to thrive in a fast paced environment
  • Attention to detail is a must
  • Knowledge of product line offering is ideal
  • College Degree Preferred.
Qualities

• Effectively communicate a team-based environment
• Can multitask and handles multiple tasks of varying complexity
• Possesses Company values of honesty, integrity and commitment coupled with the ability to accept change.