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Quality Control Specialist

2 weeks ago

Toronto, Canada Kohl & Frisch Limited Full time

Primary Role of This Position
The Quality Control Specialist shall ensure adherence to Health Canada Guideline GUI-0001 “Good Manufacturing Practices (GMP)” regarding activities applicable to a wholesaler as well as GUI-0069 “Guidelines for Environmental Control of Drugs during Storage and Transportation”. The activities and procedures governed by these guidelines have potential for direct impact on drug identity, strength, quality, and purity. Specifically, the Quality Control Specialist shall ensure adherence to the Regulations outlined below. The Quality Control Specialist reports all quality issues to the Operations Supervisor and the RA/QA Manager.

Major Responsibilities
Premises C.02.004
+ Ensures Pest Control Program maintained
+ Contractor-recommended action items addressed
+ Ensures temperature-controlled areas remain in spec
+ Investigates non-conformances
+ Ensures instruments (probes) are calibrated
+ Certificates archived
+ Ensures facility and structures remain clean and in a state of repair

Personnel C.02.006
+ Ensures training records are current and archived
+ Manufacturing Control C.02.012
+ Monitors Recalls
+ Participates in Self-Inspections
+ Monitors corrective actions

Quality Control C.02.013
+ Ensures national Standard Operating Procedures (SOPs) are adhered to
+ Ensures local Work Instructions (WIs) are up to date and adhered to
+ Ensures Hold/Release Procedures are adhered to

Quality Control C.02.014
+ Ensures Customer Returns are handled appropriately
+ Release for resale
+ Destruction

Quality Control C.02.015
+ Ensures Good Distribution Practices are adhered to
+ Participates in route profiling and shipping studies
+ Ensures Change Control is adhered to

Records C.02.021; C.02.022; C.02.023; C.02.024
+ Ensures Records are archived as per WI/SOP
+ Ensures Good Documentation Practices are followed
+ Ensures Deviations are handled as per SOP

**Qualifications**:
Must be qualified by relevant academic training and experience
+ Bachelors Degree in Science or relevant education requirements
+ Experience working in a Health Canada licensed GMP-compliant environment
+ Experience working in a warehouse/distribution environment for a pharmaceutical/healthcare company is preferred
+ Strong communication skills: written and verbal;
+ Strong troubleshooting and risk mitigation skills;
Hours of Work
Monday to Friday 9:00am to 5:30pm. Being a 24 hour operation, flexibility in hours is mandatory. The Quality Control Specialist will be available to participate in Health Canada GMP audits.

Warehouse environment: this role will work closely with and support our warehouse teams, with majority of the work performed within the warehouse.

How to Apply