QA Senior Associate

Morgan McKinley; Dún Laoghaire; On-site; EUR 65,000 - 90,000; Full time

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

Job Overview:

The Senior Associate for Plant Quality Assurance (PQA) will report to the QA Manager, playing a pivotal role in the site's Quality Assurance team. As the Quality point of contact for manufacturing and inspection operations, the PQA Senior Associate will contribute to continuous improvement initiatives by undertaking additional responsibilities beyond routine QA duties.

This 24/7 shift role demands a 12-hour shift pattern (4 on, 4 off) to support manufacturing operations.

Key Qualifications & Experience:

• Exceptional written and verbal communication skills.
• Proven experience collaborating with dynamic cross-functional teams and strong decision‑making abilities.
• Robust organizational skills, with a commitment to seeing assignments through to completion.
• Demonstrated problem‑solving abilities, particularly in supporting non‑conformance/deviation investigations.
• Experience in inspecting vials and syringes and engaging in aseptic operations.
• Familiarity with applicable Regulatory requirements and proficiency in evaluating compliance issues.

Key Responsibilities:

• Ensure adherence to safety standards and SOPs in all activities.
• Review and approve production batch records and associated documentation for Qualified Person disposition activities.
• Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
• Conduct inspections of vials and syringes, annual reserve inspections, and support complaint investigations.
• Offer Quality Assurance support for on-the-floor investigations and deviations.
• Review and approve deviations for closure, ensuring compliance with appropriate documentation.
• Participate in customer complaint investigations.
• Conduct routine Quality Assurance walks on the production floor.
• Review and issue logbooks, ensuring compliance with procedures.
• Provide training and guidance to staff for effective performance.
• Review and approve cGMP records, ensuring compliance with appropriate documentation.
• Support continuous improvement and Operational Excellence initiatives.
• Undertake other tasks/projects as assigned by the manager.

Basic Qualifications & Experience:

• University degree in an Engineering or Science-related discipline (preferred).
• Over 4 years of relevant experience in the pharmaceutical or biotechnology industry or an equivalent combination of experience and educational background.