QC Compendial Analyst - Vaccines

Merck; Leinster; On-site; EUR 42,000 - 56,000; Full time

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

Job Description

Ireland - The Company

Within our Company in Ireland, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We're always looking to make a difference for people, patients, and communities - from our Company in Ireland to the world.

Our Commitment to Ireland

Ireland is one of the Ireland's leading healthcare companies, having first established here over 50 years ago. We have a dynamic and team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of our Company's top products, helping save and enhance lives in over 140 countries around the world.

As a cutting-edge, state-of-the-art vaccines facility spanning over 15,500 square metres across three stories, our Dundalk site will focus on qualification, continued product development and expanding its capabilities within our network. Featuring drug substance manufacturing, drug product manufacturing and quality control labs that will support the global supply of vaccine products - strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry-leading network.

Opportunity

An exciting opportunity is now available for a Quality Control Analyst to join and contribute to our mission of using leading-edge science to save and improve lives around the world.

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.

Required Skills

• 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)

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing talented, and committed people together.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.