Assoc. Spclst, Quality Control

Merck; Leinster; Hybrid; EUR 52,000 - 72,000; Full time

Job summary

Merck Ireland is seeking a QC Associate Specialist (Microbiology) to lead daily microbiology QC activities across a fast-paced environment. You will supervise analysts, coordinate sampling, and support manufacturing with timely data

Responsibilities include Bioburden, LAL, sterility testing, and environmental monitoring, with a focus on GDP, data integrity, and cGMP compliance while coaching junior staff.

Qualifications

• B.Sc. degree in Microbiology, Biological Sciences, or equivalent.
• Minimum of 3 years of experience in a pharmaceutical or biotechnology QC laboratory, with direct exposure to environmental monitoring and core microbiological assays.
• Demonstrated capability or strong aptitude to lead, organize, and guide other analysts in a shift-based environment.
• Strong understanding of aseptic techniques, cleanroom behavior, and clean utility operations.
• Excellent interpersonal and communication skills to effectively guide the team and handle shift-level escalations.
• Proven troubleshooting and real-time problem-solving skills under manufacturing operational pressures.
• Proficiency in QC data systems (e.g., LIMS equivalent environmental monitoring software).
• Strong knowledge of cGMP, GDocP, and basic regulatory expectation.

Responsibilities

• Act as the primary operational point of contact and shift lead, providing direct guidance, coordinating daily task allocation, and managing analyst workflows to ensure schedule adherence and on-time sample collection.
• Serve as the first-line contact for weekend technical issues, instrumentation faults, or sampling challenges. Coordinate real-time troubleshooting at the bench and execute timely escalations of critical cGMP or safety issues to QC Management.
• Perform microbiological testing, including Bioburden testing, Bacterial Endotoxin testing (LAL), and Sterility testing. Execute cleanroom Environmental Monitoring (EM) and utility sampling (WFI & clean steam) as required to support manufacturing schedules.
• Conduct timely, first-line reviews of laboratory data, analyst testing worksheets, logbooks, and environmental monitoring logs within LIMS to ensure compliance with GDP and data integrity standards.
• Deliver on-the-floor technical coaching and mentoring to junior analysts, resolving routine assay challenges and ensuring strict adherence to aseptic techniques.
• Assist in identifying on-shift deviations, documenting initial event details, and initiating immediate containment and notification steps.
• Ensure the microbiology laboratory is maintained in an inspection-ready state, adhering strictly to cleanroom behavior and cGMP guidelines.

Skills

Aseptic Handling

Bioburden

Bioburden Testing

Data Integrity

Deviation Manage

Education

B.Sc. in Microbiology / Biological Sciences

Tools

QC data systems / LIMS

Job description

Job Description

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 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.

QC Associate Specialist (Microbiology)

An exciting opportunity has arisen for a QC Associate Specialist (Microbiology) to play a key role in ensuring continuous, compliant manufacturing support. This role offers an exciting opportunity to lead a team, provide technical support, and contribute to our mission of saving and improving lives around the world.

Responsibilities

• Act as the primary operational point of contact and shift lead, providing direct guidance, coordinating daily task allocation, and managing analyst workflows to ensure schedule adherence and on-time sample collection.
• Serve as the first-line contact for weekend technical issues, instrumentation faults, or sampling challenges. Coordinate real-time troubleshooting at the bench and execute timely escalations of critical cGMP or safety issues to QC Management.
• Perform microbiological testing, including Bioburden testing, Bacterial Endotoxin testing (LAL), and Sterility testing. Execute cleanroom Environmental Monitoring (EM) and utility sampling (WFI & clean steam) as required to support manufacturing schedules.
• Conduct timely, first-line reviews of laboratory data, analyst testing worksheets, logbooks, and environmental monitoring logs within LIMS to ensure compliance with GDP and data integrity standards.
• Deliver on-the-floor technical coaching and mentoring to junior analysts, resolving routine assay challenges and ensuring strict adherence to aseptic techniques.
• Assist in identifying on-shift deviations, documenting initial event details, and initiating immediate containment and notification steps.
• Ensure the microbiology laboratory is maintained in an inspection-ready state, adhering strictly to cleanroom behavior and cGMP guidelines.

What skills you will need

• B.Sc. degree in Microbiology, Biological Sciences, or equivalent.
• Minimum of 3 years of experience in a pharmaceutical or biotechnology QC laboratory, with direct exposure to environmental monitoring and core microbiological assays.
• Demonstrated capability or strong aptitude to lead, organize, and guide other analysts in a shift-based environment.
• Strong understanding of aseptic techniques, cleanroom behavior, and clean utility operations.
• Excellent interpersonal and communication skills to effectively guide the team and handle shift-level escalations.
• Proven troubleshooting and real-time problem-solving skills under manufacturing operational pressures.
• Proficiency in QC data systems (e.g., LIMS equivalent environmental monitoring software).
• Strong knowledge of cGMP, GDocP, and basic regulatory expectation.

Required Skills

• Aseptic Handling
• Bioburden
• Bioburden Testing
• Data Integrity
• Deviation Manage

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.