Senior QA Specialist: GMP Manufacturing & Quality Lead

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

Job summary

A biopharmaceutical company in Canada is seeking a Quality Assurance expert to oversee manufacturing operations and ensure compliance with GMP standards. The ideal candidate will have a degree in chemistry and several years of relevant experience. Responsibilities include supporting audits, managing documentation, and leading quality improvement initiatives. Strong critical thinking and problem-solving skills are essential for success in this role, along with excellent communication abilities.

Qualifications

• 6+ years of relevant experience in a GMP environment with a Bachelor's degree.
• 4+ years of experience in a GMP environment with a Master's degree.
• Knowledge of GMP regulations, including ICH Q2, Q7, Q9, Q10.

Responsibilities

• Apply critical thinking to address complex manufacturing challenges.
• Provide QA oversight during manufacturing operations.
• Support internal and external audits and continuous improvement initiatives.

Skills

Critical thinking

Problem-solving

Organizational skills

Communication skills

Education

Bachelor's degree in chemistry or related field

Master's degree in chemistry or related field

PhD in Chemistry or related field

Tools

Quality Risk Management tools

Statistical quality improvement tools

Job description

A biopharmaceutical company in Canada is seeking a Quality Assurance expert to oversee manufacturing operations and ensure compliance with GMP standards. The ideal candidate will have a degree in chemistry and several years of relevant experience. Responsibilities include supporting audits, managing documentation, and leading quality improvement initiatives. Strong critical thinking and problem-solving skills are essential for success in this role, along with excellent communication abilities.