QC Senior Microbiology Analyst

 QC Senior Microbiology Analyst – Team Horizon
We are seeking applications for a senior QC Microbiology Analyst, you will support the Bulk Drug Facility in Dublin with emphasis on microbiological testing such as Environmental Monitoring, Water, Gas, Bioburden and Endotoxin, technical support regarding method validation, regulatory updates and new technologies.
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.

 
What you will be doing:

• Environmental and Facilities monitoring sampling and testing.


• Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.


• Validation/Qualification of Microbiology test methods and test systems such as the Endotoxin test system and Identification system.


• Represent the Microbiology department in internal and external audits where appropriate.


• Close out of actions/ recommendations identified from both internal and external audits.


• Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.


• Maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory.


• Perform technical review of data generated in laboratory, validation protocols and reports.


• Provide Technical support to Manufacturing and Projects which the company undertakes.


• Ensure all instruments/equipment are maintained in a calibrated and operational state.


• Ensure a high standard of housekeeping and safety is maintained in the Laboratory.


• Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.


• Keep management updated on issues arising within the laboratory.


• Scheduling of testing, review, and authorization of microbial data.


• Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.


• Train laboratory personnel and play appropriate role in the development, operation, and evaluation of training/re-training programs.

 
What you need to apply:

• Minimum of 3-year experience in cGMP Quality environment.


• Experience in testing of sterile/non-sterile pharmaceutical /biopharmaceutical products.


• Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.


• Degree in Microbiology or related science.