Our leading pharmaceutical client is looking for a Quality Control Lead Investigator who has an understanding of process/facility equipment, biological testing, cGMP, root cause analysis, and technical writing skills. He/She will be responsible for identifying root cause of failures, writing and managing the non-conformance investigations, remediation actions and implementation of the associated improvement for Quality Control department.
This is a full time contract opportunity, located in Toronto.
- Develops an investigation strategy
- Determines appropriate analytical tools, process walks and reviews or analyses required to determine root cause or identify all the possible root causes
- Works with the QO Departments (shop floor, validation) and collects data and writes/reviews drafts for non-conformance reports
- Identify recurrent issues or themes and develop improvement plan with area management or other stakeholders
- Work with the Quality Control teams to ensure actions are assigned to the appropriate departments/individuals and followed up on
- Responsible for the deviation investigation report
- Determines when investigations are complete and prepares the report for review and approval.
- Prepare pre-read documentation to support regulatory inspections and other reviews if applicable
- Work with QC Management to identify and develop process improvements to remediate risks, improve investigations or avoid future non-conformances.
- Bachelor’s Science degree in Biological Science or relevant discipline with appropriate experience.
- At least 4 years in a Laboratory Testing/Pharmaceutical Manufacturing/Manufacturing Technology/Quality Operations, or similar role
- High level of knowledge of cGMP in pharmaceuticals/biologicals
- Thorough knowledge and experience of quality control testing for biological products in an industrial setting.
- Working knowledge of the facility, equipment and utility systems (HVAC, refrigerator, freezer, incubators, etc.)
- Knowledge and experience with root cause investigational approaches
- Good problem solving skills and documentation skills
- Must possess excellent communication and organizational skills
- Excellent technical writing skills
- Six-sigma or other root cause training and experience an asset
- Knowledge and experience with multiple software programs such as Trackwise, Phenix an asset
- Working knowledge of HSE and Quality Systems
- ASQ Certification an asset
Job Type: Contract