Senior QC - Microbiology

Berkley Group; Dublin; On-site; EUR 45,000 - 65,000; Full time

Job summary

Berkley Group is seeking a Senior QC Microbiology professional for a 12 month contract (days) in Ireland. You will perform endotoxin, bioburden and sterility tests, water sampling and related lab support duties.

The role requires writing technical reports and participating in method validation and audits, with cross-functional collaboration across the lab. The candidate will have a Bachelor’s degree in science and Biopharmaceutical QC experience in microbiology.

Qualifications

• Bachelor's degree in a science discipline.
• Biopharmaceutical QC experience in a microbiology lab.

Responsibilities

• Perform endotoxin testing on water, in-process and drug product release samples.
• Conduct bioburden testing on water and in-process samples.
• Carry out sterility testing and water sampling.
• Provide lab support including indicator testing, media prep, identifications and autoclave duties.
• Write technical reports and participate in protocol/validation work.
• Assist with audits, deviations, and continuous improvement initiatives.
• Troubleshoot issues and communicate results to stakeholders.
• Review and trend analytical data and assist with regulatory filings.

Skills

Endotoxin testing

Bioburden testing

Sterility testing

Water sampling

Report writing

Audits & compliance

Method validation

Troubleshooting

Cross-functional collaboration

Lab safety

Education

Bachelor's degree in science

Job description

12 month contract with potential extension.

Snr QC Microbiology (Days)

Responsibilities

• Endotoxin testing of water, in-process and drug product release samples
• Bioburden testing of water & in-process drug product samples
• Sterility testing
• Water sampling
• Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
• Writing technical reports
• Media fill reconciliation and inspection
• Weekend bioburden cover
• Perform analytical testing as a main priority with efficiency and accuracy?
• With a high degree of technical flexibility, work across diverse areas within the lab
• Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.?
• Report, evaluate, archive, trend and approve analytical data.?
• Troubleshoot, solve problems and communicate with stakeholders.?
• Initiate and/or implement changes in controlled documents.?
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.?
• Write protocols and perform assay validation.?
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.?
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.?
• Review and Approve lab results?
• May participate in lab investigations.
• May provide technical guidance.?
• May train others.?
• May contribute to regulatory filings.?
• May represent the department/organization on various teams?
• May interact with outside resources?

Required

• Bachelors degree in a science discipline?
• Biopharmaceutical QC experience in a microbiology lab?