QC Analyst - Compendial & GMP Testing (Hybrid)

Merck

Leinster

On-site

EUR 42,000 - 56,000

Full time

4 days ago
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Job summary

Merck Ireland is seeking a Quality Control Analyst to join the QC team at our Dundalk site, contributing to the manufacture of vaccines and ensuring cGMP compliance.

You will perform allocated testing, support OOS investigations, participate in audits, and help draft procedures, training materials, and SOPs to maintain data integrity.

The role requires a science/quality/technical degree, at least two years of lab experience, strong communication, IT skills, and a proactive, collaborative mindset.

Qualifications

  • Degree qualification in a relevant discipline such as Science, Quality, or Technical.
  • Minimum of 2 years of laboratory experience, including sampling, testing, and reporting.
  • Motivated team player with the ability to contribute to a high-performing team and support the future of our company Dundalk.
  • Strong desire to continuously learn, improve, and develop.
  • Flexible, self-motivated, and adaptable.
  • Effective communication and presentation skills.
  • Proficient in IT applications, including Microsoft Office.
  • Strong critical thinking and problem-solving skills.
  • Good knowledge of cGMP, GLP, Pharmacopoeias (USP, Ph. Eur.) and Quality Management Systems.
  • Good understanding of testing requirements for raw materials, primary packaging materials, drug product, and drug substances.
  • Corrective Action Management, GMP Documentation, GMP Testing, Pharmacopoeias, pH Testing, Quality Control Management, Quality Manuals, Raw Materials, Root Cause Analysis (RCA), Standard Operating Procedure (SOP)

Responsibilities

  • Operate as part of the QC team performing the allocated testing and laboratory-based duties.
  • Serve as a testing subject matter expert within the QC department.
  • Participate in OOS investigations and support troubleshooting activities.
  • Attend daily QC Tier meetings and communicate testing progress, deviations, and any potential cGMP or compliance concerns.
  • Contribute to the drafting, revision, and rollout of operational procedures, training materials, and maintenance procedures for quality systems.
  • Conduct peer review of testing documentation and ensure data integrity compliance and achievement of QC Right First Time KPIs.
  • Support laboratory readiness, audit readiness, and audit participation.
  • Assist with laboratory equipment qualification and analytical method technical transfer, verification, and validation.
  • Maintain laboratory equipment, perform cleaning activities, and support vendor maintenance tasks.
  • Complete CMMS tasks in conjunction with equipment maintenance.
  • Contribute to a continuous improvement culture through problem-solving and troubleshooting.
  • Demonstrate a commitment to ongoing learning and personal development.

Skills

Laboratory experience
IT proficiency
Effective communication
Problem-solving
Team player

Education

Science/Quality/Technical degree

Tools

Microsoft Office

Job description

Merck Ireland is seeking a Quality Control Analyst to join the QC team at our Dundalk site, contributing to the manufacture of vaccines and ensuring cGMP compliance.

You will perform allocated testing, support OOS investigations, participate in audits, and help draft procedures, training materials, and SOPs to maintain data integrity.

The role requires a science/quality/technical degree, at least two years of lab experience, strong communication, IT skills, and a proactive, collaborative mindset.

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