QC Microbiology Analyst – MSD Ireland
MSD Ireland is seeking a dedicated QC Microbiology Analyst to join our Commercial Large-Scale Drug Substance Biotech facility in Swords.
Responsibilities
* Perform supporting activities for general lab readiness, laboratory equipment qualification and method transfers.
* Carry out routine microbiological analytical techniques, including environmental monitoring, WFI testing, growth promotion testing, in-process product testing and final product testing such as bioburden, kinetic turbidmetric, and MCS rapid endotoxin testing in compliance with GMP requirements.
* Integrate and complete all documentation on time, familiar with LIMS, keep analytical practices up to date with reference to pharmacopoeias, specifications, regulations and industry standards.
* Support the laboratory testing schedule to achieve an efficient QC system. Receive and manage samples for stability, in-process and release testing.
* Prepare reagents, perform 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 and preventive 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.
* Comply with the Quality Management System requirements.
Required Skills
* Degree qualification (Science/Quality/Technical).
* Minimum 3+ years 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.
As an equal opportunity employer, we are proud to embrace diversity and bring together talented, committed people to find solutions and treatments for the world’s most challenging healthcare needs.
If you are ready to invent solutions to meet unmet healthcare needs, please apply today.
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