Associate, QA Documentation

Job Summary

The QA Documentation QS4 works as a member of the QA department and carries out work related to documentation activities, maintaining accurate and organized records and documentation for the department and site.

Job Responsibilities

• Issues batch and other records and controlled copies of master documents to support manufacturing; updates corresponding electronic files; ensures reconciliation of controlled documents or recall of official copies of retired documents; second checks for accuracy and authenticity of records issued by other personnel
• Maintains QU GMP document storage areas: Oversees orderly retention and security of all master and executed documentation (records and logbooks); archives GMP records, logbooks, documents in a labeled, organized manner that enables efficient retrieval; maintains indexes and electronic information copies
• Identifies documentation that has reached end of retention period; provides list for management approval prior to arranging for destruction; oversees actual destruction of documentation
• Maintains, develops or improves QA document systems to support continued quality improvement
• Prepares and issues logbooks according to approved procedures
• Routes documents for approval
• Coordinates preparation of GMP documents for external distribution
• Files completed training for the QA group; supports annual review of QA department training curricula and histories
• Oversees the periodic SOP review program for the company
• Completes Change control activities which may include:
  • Authors and peer reviews change controls; ensures completeness, accuracy, and timely provision meeting business needs
  • Processes Change Control requests; ensures accurate documentation, impacts, and requirements are satisfied; ensures relevant training is completed as assigned
  • Monitors and reports on the performance and status of the change control and document management systems; tracks outstanding change controls and action items, works with assignees towards completion
• Prepares and organizes documents for customers and during audits
• Liaises with higher level QU personnel to learn and acquire a fundamental understanding of departmental and regulatory practices; may liaise with other employees in departments across the organization to ensure proper information is contained in all documents
• Works in a safe manner collaborating as a team member to achieve all outcomes
• Demonstrate Behaviours that exhibit our organizational Values: Integrity, Courage, Teamwork, and Innovation
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies
• All other relevant duties as assigned

Job Requirements

• Education

• Education at the post-secondary level

• Knowledge, Skills and Abilities
  • Good practical experience in document archiving and control
  • Uses sound technical judgement in making decisions
  • Good written, oral communication skills and attention to detail
  • Good organizational, multi-tasking and planning skills
  • Proficiency in computer applications (i.e. Word, Excel)
• Experience

• Preferably 1-2 years of experience in related field of GMP documentation.