QA Deviations & CAPA Specialist: Impact & Compliance

Emergent BioSolutions, Inc.; Winnipeg; On-site; CAD 80,000 - 110,000; Full time

Job summary

Emergent BioSolutions in Winnipeg seeks a Quality Assurance Deviations and CAPA Specialist to manage deviations and CAPA processes, ensuring QA systems support safe, compliant manufacturing. The role provides technical leadership in deviations, CAPA, and quality systems across GMP environments.

The successful candidate will review investigations, lead root cause analyses, and participate in regulatory inspections or customer audits while training QA staff and collaborating with cross-functional

Qualifications

• BS in a related discipline with 5+ years of experience.
• Advanced technical knowledge in QA or Quality Systems.
• Broad regulatory knowledge of FDA, Health Canada, EMA GXP regulations.
• Detail-oriented, team-focused, customer-oriented.
• Excellent written and verbal communication; ability to influence.

Responsibilities

• Manage deviations and CAPA investigations with root cause analysis.
• Prepare deviation summaries and system reports.
• Review and approve Deviations and CAPAs.
• Support QA during regulatory inspections or customer audits.
• Train QA specialists and participate in cross-functional teams.

Skills

Quality Systems

GXP regulations

Analytical skills

Regulatory compliance

Communication skills

Education

Bachelor of Science

Job description

Emergent BioSolutions in Winnipeg seeks a Quality Assurance Deviations and CAPA Specialist to manage deviations and CAPA processes, ensuring QA systems support safe, compliant manufacturing. The role provides technical leadership in deviations, CAPA, and quality systems across GMP environments.

The successful candidate will review investigations, lead root cause analyses, and participate in regulatory inspections or customer audits while training QA staff and collaborating with cross-functional