Assoc. Spclst, Quality Control

MSD UK; Leinster; Hybrid; EUR 52,000 - 76,000; Full time

Job summary

Merck & Co., Inc. in Ireland seeks a QC Associate Specialist (Microbiology) to lead microbio testing and environmental monitoring, ensuring cGMP compliance. The role involves coaching analysts, troubleshooting issues, and maintaining inspection-ready lab facilities within a hybrid work model.

The position requires a B.Sc. in Microbiology or related field, 3+ years in pharma/biotech QC, and strong aseptic technique. Flexibility for weekend support and collaboration across sites is expected.

Qualifications

• B.Sc. degree in Microbiology or equivalent.
• Minimum 3 years in pharma/biotech QC with environmental monitoring.
• Ability to lead, organize, and guide other analysts in a shift-based environment.
• Strong aseptic techniques and cleanroom behavior.
• Excellent interpersonal and communication skills.
• Proficiency with QC data systems (LIMS or equivalent).

Responsibilities

• Act as the primary operational point of contact and shift lead, guiding tasks and analyst workflows.
• First-line contact for weekend technical issues, troubleshooting, and escalation of cGMP or safety issues.
• Perform microbiological testing including Bioburden, LAL, and Sterility testing.
• Conduct Environmental Monitoring and sampling (WFI & clean steam) as required.
• Review laboratory data, worksheets, logbooks, and EM logs to ensure GDP compliance.
• Provide on-the-floor coaching to junior analysts and resolve assay challenges.
• Identify deviations and initiate containment and notification steps.

Skills

Aseptic Handling

Bioburden

Bioburden Testing

Data Integrity

Deviation Management

Deviation Reporting

Endotoxins

Environmental Monitoring

GMP

Laboratory Analysis

Laboratory Testing

Teamwork

Education

B.Sc. in Microbiology / Biological Sciences or equivalent

Tools

LIMS / Environmental Monitoring Software

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

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.

Bring energy, knowledge, innovation to carry out the following:

• 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

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.

Please feel free to speak to us about what flexibility means to you during your application.

Required Skills:

Aseptic Handling, Bioburden, Bioburden Testing, Data Integrity, Deviation Management, Deviation Reporting, Endotoxins, Environmental Monitoring, Good Manufacturing Practices (GMP), Laboratory Analysis, Laboratory Testing

Preferred Skills:

Teamwork

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 09/15/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.