MSD Quality Control Microbiology Associate Specialist 

Ireland, Dublin 

651093039

Job Description

A fantastic opportunity has arisen for aQC Microbiology Associate Specialist.This role is a critically important activity to ensure efficient and effective compliant operation of the new strategic Drug Substance facility. This person will be key in the day to day planning and running of lab testing to ensure the process is streamlined and in line with lean methodologies.

You will be the key leading talent in analytical techniques and developing the flow of testing through the lab, to ensure the lab will be best in class across our industry, a benchmark for others to aspire to. You will support the specialist role function in the lab and will provide support to other analysts within the lab area, including training and guidance on their area of expertise.

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

• Work as directed by the Associate Director Quality Control /Quality Control Manager (Bioanalytical) according to Company safety policies, cGMP and cGLP.
• Drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Participates in the method transfer of analytical techniques for Chemistry testing.
• Plan and perform multiple, complex routine/ non-routine methods and procedure when required.
• Participate in the peer review of analytical data
• Provide technical guidance and apply expertise and critical thinking to help to resolve technical issues.
• Lead training of staff on technical aspects of the role.
• Revise and implement procedures that comply with appropriate regulatory requirements
• Qualification of analytical equipment and related testing functions
• Compliance with Standard Operating Procedures and Registered specifications
• Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP
• Participate in laboratory Investigation Reports and deviations through the Non-Conformance procedures
• Participate in the generation and update of SOP’s, trend data, investigations, nonconformances, validation protocols, reports, method validation/verifications and equipment qualifications
• Plan and implement procedures and systems to maximise operating efficiency
• Contribute to the achievements of department productivity and quality goals
• Represent the QC Department on site/inter departmental projects.
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Plan and maintain the laboratory testing schedule to achieve an efficient QC system
• Maintain good housekeeping and hygiene within the laboratory.
• Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
• Ensure training is current for all job functions performed.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues

What skills you will need:

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

• Relevant experience and skill sets in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting
• Experience and critical skills in the area of expertise that add value to the business; ideally analytical microbiology, in a GMP setting
• Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
• Knowledge of cGMP
• Laboratory Quality Systems
• Report, standards, policy writing skills required
• Lean Six Sigma Methodology experience.
• Understand the specific responsibilities of all departments as they relate to ones own department, understanding the business processes ones department supports
• Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our

So, if you are ready to:

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

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Posting End Date:07/03/2024

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.