Benefits:
Gym Access
Dental insurance
Health insurance
We’re looking for a meticulous and detail-oriented QA Document Reviewer to join our team!
In this role, you will be responsible for auditing all production-related documents to ensure compliance with Good Documentation Practices (GDP) in accordance with current Good Manufacturing Practices (cGMP). Your keen eye for detail will help identify and correct non-conformances, ensuring the integrity and accuracy of our production documentation.
If you have a passion for quality and compliance, we’d love to hear from you!
JOB RESPONSIBILITIES
• Audit on-line documentation practices to ensure GDP requirements are met & completed
• Review of production batch records for completeness and accuracy
• Interact with production personnel in educating them on correction, addition and completion of such records per applicable GMPs
• Provide guidance including on-line training to maintain process control when required.
• Review Statistical Process Control Charts (SPC), production Fill Sheets, Batch Sheets etc. ensuring complete Batch Record review - assuring that there are no errors; if errors or omissions have occurred, that they have been corrected appropriately.
• Ensure that all documentation meets cGMP Compliance.
• Issue and assign process of corrective action for rework.
• Generate reports as required, including statistical analysis based on documentation.
• Create and maintain an orderly filing system including hard copy and electronic databases for batch records, CofA’s, etc.
• Adhere to all QA/QC and Company policies and procedures including health and safety.
• Follow procedures and wear required PPE per safety guidelines.
• Identify and report any hazard(s), accidents, and injuries requiring first aid, health care, lost-time injuries, occupational diseases or incidents in the workplace.
• Use equipment, materials and machinery only as authorized.
• Any other related duties as required
JOB REQUIREMENTS
• 3-5 years of experience with a high school diploma or equivalent
• 2-3 years of experience with post-secondary education or relevant certification/license
• Previous experience in a cGMP environment is an asset
• Computer literacy is considered an asset
• Knowledge of Good Documentation Practices (GDP) and experience performing related audits
