Quality Control Specialist — GMP, Data Integrity & Investigations

Msd Ireland; Carlow; Hybride; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Merck & Co., Inc. is seeking a Quality Control Associate Specialist at our Carlow site. The role supports QC operations and quality systems to ensure adherence to cGMP, regulatory requirements, and company standards, delivering robust product quality and reliable supply.

You will mentor colleagues in compliant documentation, support GMP documentation, and assist with NPI, technology transfers, and lifecycle activities from a QC perspective. A hybrid work model is offered where possible.

Qualifications

• 4 years of cGMP QC experience in a regulated pharma/biopharma environment.
• Demonstrated experience with HPLC/ELISA systems and associated software.
• Bachelor's degree or higher in Analytical Chemistry, Biochemistry, or related discipline.

Responsabilités

• Execute and support QC activities aligned with Global Policies and the Global Quality Management System.
• Ensure cGMP compliance and regulatory expectations across activities.
• Demonstrate strong data integrity culture and inspection readiness.
• Review testing documentation to ensure data integrity and QC Right First Time KPIs.
• Serve as subject matter expert for QC documentation systems and lifecycle management.

Connaissances

ELISA

GMP

HPLC

Regulatory compliance

Quality systems

QMS

Formation

Bachelor's degree in Analytical Chemistry/Biochemistry

Outils

HPLC

ELISA

Description du poste

Merck & Co., Inc. is seeking a Quality Control Associate Specialist at our Carlow site. The role supports QC operations and quality systems to ensure adherence to cGMP, regulatory requirements, and company standards, delivering robust product quality and reliable supply.

You will mentor colleagues in compliant documentation, support GMP documentation, and assist with NPI, technology transfers, and lifecycle activities from a QC perspective. A hybrid work model is offered where possible.