Global Quality Assurance Specialist

Description

Company Bio

Role Overview

Key Responsibilities

• Provide Global Quality Assurance oversight of Contract Manufacturing Organizations (CMOs) and third-party logistics partners (3PLs).
• Review and assess CMO and 3PL quality activities.
• Author and manage internal deviations, change controls, and related QA documentation.
• Perform batch record review and product release activities.
• Manage product complaint intake and documentation.
• Draft internal Annual Product Quality Reviews (APQRs).
• Support Quality System Management Reviews (QSMRs).
• Track and trend internal and external quality metrics.
• Support and lead internal and external audits.
• Support quality and process improvement initiatives.
• Verify and monitor product shipments.
• Support commercial serialization activities.

Education, Experience, and Skill Requirements

• College diploma or bachelor’s degree in a scientific or technical discipline preferred, or an equivalent combination of education and experience.
• Minimum of 6 years of Quality Assurance experience within the pharmaceutical or biotechnology industry.
• Working knowledge of Health Canada GMP and GDP regulations and U.S. FDA requirements.
• Proficiency with electronic Quality Management Systems (eQMS).
• Familiarity with project management and data analysis tools.
• Demonstrated ability to work independently and collaborate effectively.
• Proficiency in Microsoft Office.
• Demonstrated written and verbal communication skills.
• Experience supporting QA oversight of contract manufacturing or distribution partners.
• Excellent attention to detail and accuracy in documentation review.
• Excellent organizational, problem solving, and record keeping skills.

Additional Information

• Base salary range: $70,000-$100,000
• Remote position with travel requirements up to 10%, including international travel as needed.