Quality Assurance Manager

Actalent; Edmonton; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading life sciences firm in Edmonton is seeking a Quality Assurance Lead / Manager to oversee GMP activities and ensure compliance with regulatory standards. The ideal candidate will have extensive QA experience, strong critical thinking skills, and the ability to manage multiple priorities. This fully onsite position offers a pay range of $85.00 - $90.00 per hour.

Qualifications

• 8+ years of QA experience in a GMP environment.
• Strong interpersonal and organizational skills.
• Experience with analytical techniques (GC, LC, MS, NMR).

Responsibilities

• Oversee and approve batch manufacturing and testing records.
• Conduct training for QA specialists.
• Participate in internal audits for regulatory compliance.

Skills

Quality Assurance

GMP Compliance

Critical Thinking

Problem-Solving

Analytical Techniques

Education

BS/BA degree with 8+ years of QA experience

MS degree with 6+ years of QA experience

PhD in Chemistry with 2+ years of QA experience

Job description

Position Summary

We are seeking a proactive and experienced Quality Assurance Lead / Manager to oversee GMP activities and ensure compliance with regulatory standards and operational excellence. This role involves managing daily QA tasks, conducting training, and resolving complex quality issues through critical thinking and sound judgment. The ideal candidate is a motivated professional with a strong ability to learn quickly, work independently, and drive continuous improvement.

Key Responsibilities

• Review and approve batch manufacturing and testing records
• Oversee and approve deviations, changes, and CAPAs at the site or contract testing laboratories
• Review and approve qualification documents for equipment, analytical instruments, and computer systems
• Approve test methods and method validation / transfer reports
• Investigate and approve lab issues related to release testing and method validation / transfer
• Participate in internal audits, including review of analytical data, audit trails, and stability program data
• Support inspection readiness and regulatory compliance activities
• Train QA Specialists on manufacturing-related QA activities
• Lead and contribute to continuous improvement initiatives aligned with international regulations and industry best practices

Qualifications

Education (Preferred)

• BS / BA degree with 8+ years of QA experience in a GMP environment
• MS degree with 6+ years of QA experience in a GMP environment
• PhD in Chemistry with 2+ years of QA experience in a GMP environment

Skills & Competencies

• Strong critical thinking and problem-solving abilities
• Ability to manage multiple priorities independently
• Excellent verbal and written communication skills
• Strong interpersonal and organizational skills
• Experience with analytical techniques (GC, LC, MS, NMR, molecular characterization) is an asset
• Familiarity with Six Sigma, DMAIC methodology, risk management tools, and quality improvement statistical tools is advantageous

Top Skills

• Quality Assurance
• GMP Compliance

Experience Level

• Expert Level

Pay and Benefits

The pay range for this position is $85.00 - $90.00 / hr.

Workplace Type

This is a fully onsite position in Edmonton,AB.

Equal Employment Opportunity Statement

Actalent est un employeur souscrivant au principe de l’égalité des chances et accepte toutes les candidatures sans tenir compte de la race, du sexe, de l’âge, de la couleur, de la religion, des origines nationales, du statut d’ancien combattant, d’un handicap, de l’orientation sexuelle, de l’identité sexuelle, des renseignements génétiques ou de toute autre caractéristique protégée par la loi.

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