Senior QA & Compliance Specialist - cGMP Leader

Lonza; Alberta; On-site; CAD 75,000 - 95,000; Full time

Job summary

A leading biopharmaceutical company in Alberta is seeking a Senior QA Specialist to support Quality Assurance activities in a cGxP manufacturing facility. The ideal candidate will have 5 to 10 years of experience in the Quality field within the biopharmaceutical industry, with a strong understanding of regulatory requirements. Responsibilities include leading deviation investigations, performing material release, and ensuring compliance with SOPs. Join us in making a meaningful difference in people's lives through science.

Qualifications

• 5 to 10 years of experience in Quality in the Biopharmaceutical industry.
• Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).
• Good knowledge of quality management systems in a GMP facility.

Responsibilities

• Support day-to-day Quality Assurance activities in accordance with approved SOPs.
• Lead in complex deviation investigations and CAPA proposals.
• Perform material release and qualification, and review vendor’s investigation reports.

Skills

Quality Assurance

Regulatory Requirements

Teamwork

Effective Communication

Analytical Skills

Education

Degree in Engineering/Science

Job description

A leading biopharmaceutical company in Alberta is seeking a Senior QA Specialist to support Quality Assurance activities in a cGxP manufacturing facility. The ideal candidate will have 5 to 10 years of experience in the Quality field within the biopharmaceutical industry, with a strong understanding of regulatory requirements. Responsibilities include leading deviation investigations, performing material release, and ensuring compliance with SOPs. Join us in making a meaningful difference in people's lives through science.