Senior QA Associate - 12-Hour Shift, GMP Quality Lead

Morgan McKinley

Dún Laoghaire

On-site

EUR 65,000 - 90,000

Full time

7 days ago
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Job summary

Morgan McKinley is seeking a Senior Associate in Plant Quality Assurance to join the site QA team in Ireland. The role reports to the QA Manager and focuses on quality oversight for manufacturing and aseptic operations.

This 12-hour shift pattern (4 on, 4 off) supports vial/syringe Fill Finish, media fills, deviation handling, and continuous improvement within cGMP compliance. Strong collaboration, problem-solving, and regulatory knowledge are required.

Qualifications

  • Strong written and verbal communication skills.
  • Experience collaborating with cross-functional teams and making decisions.
  • Organized with focus on completion of assignments.
  • Problem-solving experience in investigations of deviations/non-conformances.
  • Experience inspecting vials/syringes and aseptic operations.
  • Familiarity with regulatory requirements and compliance evaluations.

Responsibilities

  • Provide real-time quality oversight for production units including aseptic Fill Finish.
  • Review production batch records and QA disposition activities.
  • Support on-the-floor investigations and deviation management.
  • Participate in customer complaint investigations and logbook review.
  • Conduct quality walks and provide training to staff.
  • Ensure cGMP documentation compliance and continuous improvement.

Skills

Communication
Cross-functional teamwork
Decision-making
Organization
Problem-solving
Regulatory awareness
aseptic inspection

Education

University degree in Engineering or Science

Job description

Morgan McKinley is seeking a Senior Associate in Plant Quality Assurance to join the site QA team in Ireland. The role reports to the QA Manager and focuses on quality oversight for manufacturing and aseptic operations.

This 12-hour shift pattern (4 on, 4 off) supports vial/syringe Fill Finish, media fills, deviation handling, and continuous improvement within cGMP compliance. Strong collaboration, problem-solving, and regulatory knowledge are required.

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