Quality Compliance Specialist at Emergent
4 days ago
Canada
Emergent BioSolutions
Full-time
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Elevate quality standards with Emergent as a Specialist I in Quality Compliance. Lead internal audits, manage regulatory inspections, and enhance compliance performance in Winnipeg.
As a Specialist I at Emergent, you will support regulatory audits and manage logistics for compliance inspections. Your role includes planning and conducting audits, managing corrective actions, and ensuring adherence to cGxP requirements. You will leverage your experience to influence quality improvement initiatives and uphold the integrity of our quality systems.
Key Responsibilities
• Plan and conduct internal quality system audits
• Lead audit teams and provide training throughout audits
• Prepare comprehensive audit plans and reports
• Assess compliance with GxP regulations and internal standards
• Verify effectiveness of corrective actions for compliance gaps
Requirements:
• Bachelor’s degree in Science or related field
• Minimum 5 years in regulated life sciences, 4 in QA
• Strong knowledge of cGMP and GxP regulations
• Proven experience with internal audits and CAPAs
• Excellent analytical and communication skills Drive excellence in quality compliance at Emergent while ensuring the safety of communities worldwide.
Key Responsibilities
• Plan and conduct internal quality system audits
• Lead audit teams and provide training throughout audits
• Prepare comprehensive audit plans and reports
• Assess compliance with GxP regulations and internal standards
• Verify effectiveness of corrective actions for compliance gaps
Requirements:
• Bachelor’s degree in Science or related field
• Minimum 5 years in regulated life sciences, 4 in QA
• Strong knowledge of cGMP and GxP regulations
• Proven experience with internal audits and CAPAs
• Excellent analytical and communication skills Drive excellence in quality compliance at Emergent while ensuring the safety of communities worldwide.