Microbiology Analyst
Eurofins
Dunboyne, Ireland
Job Description
The purpose of this job is to work in a cross functional team to support the Microbiology Quality Control testing function, ensuring compliance with cGMP.
Job Responsibilities Include:
- Conducting microbiology analysis including bioburden testing, endotoxin testing, microbial identification, Biological Indicator testing, BacT/ALERT testing, sterility checks, and growth promotion of media as required.
- Carry out environmental monitoring including viable and non-viable particulate monitoring and water and gas system monitoring in cleanroom areas in the manufacturing facility.
- Reading of test plates, data review, trending.
- Performance of laboratory sampling and testing.
- Provide support and subject matter expert knowledge in investigations associated with deviations.
- Provide assistance to other members of staff where required.
- To work on own initiative and be capable of developing solutions to problems as part of a team.
- To participate in the preparation of protocols and reports.
- To document data as dictated by current client policies and procedures.
- Meet with the client project team lead daily and provide updates.
- Ensure that the customer gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
- To revise SOPs as required by the Lead Analyst or client representative.
- To review analytical data for GMP compliance.
- Demonstrate problem solving in delivering process and analytical understanding.
- Good understanding of requirements for working in a GMP environment.
Qualifications
- A degree in Microbiology or a related discipline is required with a minimum of 1 years’ within a pharmaceutical regulatory environment.
- Ability to work independently and meeting established timelines.
- Academic and or practical EM experience is a requirement for this role.
- Knowledge of cGMPs.
- Excellent communication skills both written and verbal.
- Customer focus; takes personal responsibility for speed; quality and accuracy of delivery.
- Self-motivated and ability to work under pressure.
- Successful track record in achieving goals as part of a team within a growing, dynamic environment.
- Demonstrated adaptability and flexibility to support a growing organisation.
- Good understanding of requirements for working in a GMP environment.
- Ability to quickly learn new processes.
- Ability to communicate clearly and to form strong working relationships with colleagues.
- Ability to work in a lab environment with some supervision and be capable of developing solutions to problems as part of a team.
- Willing to operate in a flexible manner and able to reuse both internal and external experiences and incorporate them into relevant improvements. Ability to switch priorities at short notice is desired.
- Good team player, organised, accurate, have strong documentation skills.
- Passionate about quality and customer service.
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