Documentation Specialist

The Documentation Specialist is part of the QA department and is the central contact person for the management of documents related to Quality Systems. The Documentation Specialist ensures the proper operation, tracking and maintenance of these systems and serves as the main administrator of the Official Documentation list and filing systems to ensure their accuracy and continued compliance.

Position Summary

General Duties

• Ensure systems related to document control are in place and in use to provide adequate assurance of data integrity.
• Maintain knowledge and understanding of current GMPs.
• Ensures that all GMP-impacting activities are performed in compliance with procedures.
• General Departmental Duties (to be performed upon request):
• Manage records and documents (rendering documents effective, managing retention policies, records disposal).
• Maintain the assigned systems-related files and databases up to date; ensure that quality-related tasks are captured and follow-up with stakeholders for timely completion.
• Serve as Quality Representative (on topics related to role specific Duties)
• Role-specific Duties:
• Responsible for the management of the document control process and electronic system
• Issue Controlled copies of the SOP and other documents Issue Batch Production Record, Laboratory Notebook, Solution Logbook and Activity Logs,
• Issue Production labels,
• Update and issue the assigned quality system-related Registers, Logs and databases,
• Ensure that Quality Management Systems (including electronic list and system) are up to date,
• Follow up with Biodextris staff on performance of periodic actions from the assigned quality systems to ensure their timely completion,
• Maintains the archiving area and track the access to the documentation,
• Manage document archiving and retrieval
• Track meeting actions and minutes, and communicate actions from meetings,
• Serve as back-up to Quality Assurance Specialists Level 1.
• Perform other quality related tasks, as needed.

Education and Experience

Education and Experience Requirements

• DEC or B.Sc degree in a related field (chemistry, biology, biochemistry or any other related field like Archiving, Documentation Technician) and 2 years related experience (or equivalent combined education with relevant work experience).