QC Micro Analyst: Microbiology GMP Specialist

Morgan McKinley; Leinster; On-site; EUR 42,000 - 62,000; Full time

Job summary

Morgan McKinley is seeking an experienced QC Associate for a microbiology role in Ireland. The position focuses on endotoxin, bioburden, sterility testing, water sampling, and data/report management within a GMP lab.

Some weekend hours and shift work may be required to support manufacturing operations. Minimum qualifications include a Bachelor's degree in a science discipline and prior biopharmaceutical QC experience in a GMP environment.

Qualifications

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

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: 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 accuracy.
• Plan and perform multiple routine/non-routine methods with various assays.
• Report, evaluate, archive, trend and approve analytical data.
• Troubleshoot and communicate with stakeholders.
• Initiate/implement changes in controlled documents.
• Participate in audits, initiatives, and projects.
• Write protocols and perform assay validation.
• Introduce new techniques to the lab including method transfers, reports and validations.
• Evaluate lab practices for compliance and operational excellence.

Skills

QC testing

Microbiology techniques

Documentation

Analytical data review

Regulatory compliance

Troubleshooting

Education

Bachelor's degree in a science discipline

Job description

Morgan McKinley is seeking an experienced QC Associate for a microbiology role in Ireland. The position focuses on endotoxin, bioburden, sterility testing, water sampling, and data/report management within a GMP lab.

Some weekend hours and shift work may be required to support manufacturing operations. Minimum qualifications include a Bachelor's degree in a science discipline and prior biopharmaceutical QC experience in a GMP environment.