QC Microbiology Analyst

Job Description

A fantastic and exciting opportunity has arisen for a QC Microbiology Analyst our Commercial Large-Scale Drug Substance Biotech facility in Swords.

This role is a critically important activity, ensuring efficient and effective compliant design, construction, qualification, and operation of the Biotech Drug Substance facility in Swords. This position will be responsible for qualifying the Microbiology Quality Control lab and the transfer of Microbiological analytical methods including but not limited to cutting edge Rapid Microbiological Methods. This person will be key in the layout of the lab testing flow to ensure the process is streamlined and in line with lean principles.

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

• Perform supporting activities for general lab readiness, laboratory equipment qualification and method transfers.
• Perform and carry out a variety of routine microbiological analytical techniques environmental monitoring, WFI testing, growth promotion testing, In-process product testing, Final product testing such as bioburden and both Kinetic turbidmetric and MCS rapid endotoxin testing in compliance with GMP requirements.
• To integrate and complete all documentation on time and be familiar with LIMS.
• Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
• Support the laboratory testing schedule to achieve an efficient QC system.
• Receive and manage samples that come into the lab for stability, in-process and release testing.
• Reagent preparation, cleaning, and routine equipment maintenance. Maintain good housekeeping and GLP within the laboratory. Calibrate and maintain all designated laboratory instruments.
• Participate in risk assessments, inspections, audits, incident investigations, and implement and follow-up on corrective / preventative measures.
• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations. Ensure that cGMP standards are maintained at all times.
• Promote and participate in the implementation and maintenance of the relevant safety programmes.
• Participate and Comply with the Quality Management System requirements.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Degree qualification (Science/Quality/Technical).
• Minimum 3+ yrs in a highly regulated drug substance manufacturing environment.
• Experience with routine microbiological analytical techniques and testing.
• Proficient in the use of GLIMS
• Strong problem-solving skills and attention to detail.

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 diverse, talented, and committed people together.

Please don’t hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

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.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Required Skills:

Accountability, Accountability, Analytical Method Development, Analytical Method Transfer, Bioburden Testing, Biological Manufacturing, Chemical Analysis, Chemical Biology, Endotoxin Testing, Environmental Monitoring, GMP Compliance, Integrity Management, Laboratory Information Management System (LIMS), Laboratory Techniques, Microbial Assays, Microbiological Analysis, Process Improvements, Product Testing, QC Microbiology, Quality Control Management, Quality Management, Regulatory Compliance, Risk Assessments, Sample Testing, Six Sigma {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/31/2025

• 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.

Read Full Description