North York, Ontario
Quality Assurance Associate
Quality Assurance Associate
North York, ON
Perm or Temp
Investigate all major, critical and recurring deviations associated within the Platform.
Collaborate with Quality Operations (QO), Subject Matter Experts (SME) and Lead Investigators (LI) from other departments as required; determine the scope of the investigation.
Develop an investigation strategy in collaboration with Production, Quality Operations, SMEs.
Select appropriate analytical tools, conduct process walks, collect and analyze data to determine root cause.
Identify expertise required for the investigation (QC, QOVS, QOSA, MTech, Technical Services).
Identify, co-ordinate and manage contributions from other departments.
Participate in Focus Factory Support teams for planning and execution of investigations.
Review and provide guidance on reports prepared by technical staff.
Support manufacturing investigations associated with OOS/OOTs, Utility Interruptions, Environmental Monitoring excursions, Complaints.
Support investigations of minor non-conformances and development of templates as required.
Develop and present risk assessments:
Work with SMEs and appropriate QO experts; develop assessment of risk to product, process and other stages.
Present to Material Review Board as required.
Develop appropriate corrective and preventive actions:
In collaboration with platform management and other stakeholders, develop appropriate CAPAs to address the root cause.
Create and manage associated Change Controls and CAPAs.
Identify recurrent issues or themes and develop improvement plan with area management or other stakeholders.
Work with the area FFaST team to ensure actions are assigned to the appropriate individuals.
Work with Platform Leaders to identify and develop process improvements to remediate risks, improve investigations and avoid future deviations.
Write and manage associated documentation and timelines:
Responsible to draft clear, concise and comprehensive investigation reports and/or manufacturing investigation reports.
Manage the deviation review process and ensure the deviation is closed according to targeted timelines.
Manage investigation timelines appropriately and attend the Deviation Review board as required.
Present and defend investigations in regulatory inspections and other audits.
Four (4) years of previous relevant experience in Commercial Manufacturing, Manufacturing Technology, Quality Operations or similar role.
High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment
Experience in regulatory inspections
Good problem solving skills and documentation skills
Must possess excellent communication and organization skills.
Excellent technical writing skills
Six-sigma or other root cause training and experience
Knowledge and experience with multiple software programs such as SAP, Trackwise, Word, Outlook, Visio and PowerPoint
Bachelors' degree but prefers MSc. in Microbiology, Biochemistry, Engineering, Biotechnology or Related Science