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Quality Assurance Specialist I

3 months ago

Winnipeg, Manitoba, Canada Emergent Biosolutions Full time

About Emergent BioSolutions

At Emergent BioSolutions, we foster a culture of respect, innovation, and growth. Our team is composed of dedicated professionals committed to advancing their scientific and technical skills to develop life-saving products.

Position Overview

The Quality Assurance Deviations and CAPA Specialist plays a crucial role in managing deviations and corrective/preventative actions within our quality systems. This position requires technical expertise in quality assurance processes, manufacturing protocols, quality control, supplier quality management, and product development activities. The specialist will ensure that all deviation and CAPA processes are executed in accordance with established procedures.

Key Responsibilities

  • Manage Non-Conformances and Quality Systems reports.
  • Oversee change actions review and approval processes.
  • Ensure compliance with Good Manufacturing Practices (GMP) and adherence to company procedures.

Duties Include:

  • Administration of Deviation and CAPA processes through consultation, review, and participation in investigations.
  • Conduct thorough investigations, including product impact assessments and root cause analyses.
  • Ensure CAPA effectively addresses root causes to prevent future occurrences.
  • Prepare deviation summaries and generate system reports.
  • Participate in regulatory inspections and customer audits as a QA representative.
  • Contribute to training initiatives for QA Specialists.

Qualifications

  • Bachelor's degree in a relevant scientific discipline with a minimum of 5 years of experience or equivalent skills.
  • Advanced knowledge in Quality Assurance or Quality Systems is essential.
  • Comprehensive understanding of pharmaceutical analytical and manufacturing techniques.
  • Solid familiarity with FDA, Health Canada, and EMA GXP regulations.
  • Detail-oriented with strong teamwork and customer focus.
  • Excellent communication, influencing, and negotiation skills.
  • Able to work collaboratively or independently as needed.

Additional Requirements:

  • Citizenship/Permanent Resident or Valid Work Permit.
  • Successful completion of a Criminal Record Check.

At Emergent BioSolutions, we offer diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements, and a comprehensive benefits package. Your privacy is respected, and any information submitted will be handled in accordance with our Privacy Policy.