Quality Assurance: Deviations & CAPA Specialist

Emergent BioSolutions; Winnipeg; On-site; CAD 85,000 - 115,000; Full time

Benefits offered by this job

Competitive salaries

Flexible work arrangements

Extensive benefits package

Job summary

Emergent BioSolutions in Winnipeg is seeking a Quality Assurance Deviations and CAPA Specialist to manage deviations and CAPA processes, ensuring investigations include root cause analysis and effective corrective actions in support of GMP-compliant manufacturing.

The role collaborates with QA, manufacturing and quality control to maintain product quality, support regulatory inspections, and drive continuous improvement across the quality systems at the Winnipeg facility.

Qualifications

• Bachelor of Science in a related discipline with 5+ years of experience or equivalent.
• Advanced knowledge of Quality Assurance, Quality Systems and CAPA.
• Strong understanding of FDA/Health Canada/EMA GXP regulations.

Responsibilities

• Deviation and CAPA management and investigations
• Non-conformances handling and root cause analysis
• Quality Systems reports and improvement projects
• Inspection and audit management
• Support regulatory inspections and customer audits
• Train QA specialists

Skills

CAPA Management

Deviation Handling

Quality Systems

GXP Knowledge

Root Cause Analysis

Documentation Skills

Regulatory Expertise

Education

Bachelor of Science

Job description

Emergent BioSolutions in Winnipeg is seeking a Quality Assurance Deviations and CAPA Specialist to manage deviations and CAPA processes, ensuring investigations include root cause analysis and effective corrective actions in support of GMP-compliant manufacturing.

The role collaborates with QA, manufacturing and quality control to maintain product quality, support regulatory inspections, and drive continuous improvement across the quality systems at the Winnipeg facility.