Senior QC Analyst: External Manufacturing & Analytics

Morgan McKinley; Ireland; On-site; EUR 70,000 - 90,000; Full time

Job summary

Morgan McKinley in Ireland is seeking a Senior Quality Analytical Specialist for a 12-month contract based in Dublin. You will support analytical testing for RSM, intermediates, APIs, and drug products within an external manufacturing environment, coordinating with CMOs and CTLs.

You will lead investigations, oversee change controls, and act as a QC SME during audits, partnering with global centers of excellence to ensure compliance with ICH, FDA, and EU GMP guidelines.

Qualifications

• Bachelor's degree in Life Sciences or related discipline.
• 3–5 years of GMP Quality Control laboratory experience.
• Solid understanding of global regulatory requirements (FDA/EU GMP).
• Strong Quality Management Systems (QMS) knowledge for laboratory operations, investigations, and change control.
• Hands-on testing experience across RSM, Intermediates, APIs and Drug Products; experience with method transfers, validation, and troubleshooting.

Responsibilities

• Provide technical analytical expertise and troubleshooting across external pharmaceutical manufacturing operations.
• Coordinate product testing across CMOs and contract laboratories with internal/external stakeholders.
• Act as analytical liaison for contract manufacturing and testing partners, resolving queries with cross-functional teams.
• Lead investigations, deviations, and OOS events; contribute to release decisions with QP/RP.

Skills

GMP QC lab

Analytical testing

Method transfers

Method validation

Troubleshooting

Education

Bachelor's degree in Life Sciences

Tools

TrackWise

Veeva

Job description

Morgan McKinley in Ireland is seeking a Senior Quality Analytical Specialist for a 12-month contract based in Dublin. You will support analytical testing for RSM, intermediates, APIs, and drug products within an external manufacturing environment, coordinating with CMOs and CTLs.

You will lead investigations, oversee change controls, and act as a QC SME during audits, partnering with global centers of excellence to ensure compliance with ICH, FDA, and EU GMP guidelines.