QC Microbiology Analyst

About the Company:

Innopharma Technical Services, part of Innopharma Group, specializes in the training and provision of highly skilled, project ready, Contract Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.

Are you ready to take the next step in your career within a leading biopharma environment?

We have multiple QC Microbiology Analyst roles available with our multi-national clients across Ireland, to support the QC Microbiology laboratories.

About the position:

The QC Microbiology Analysts will be responsible for supporting Drug Substance and Drug Product, Oral solid dose, site activities related to Environmental Monitoring, Utility sampling, Biological Indicator testing, Media Fill, UV and HPLC in-process testing and sample processing.

Responsibilities include but not limited to:

• Perform routine microbiological testing on raw materials, in-process samples, drug substance, drug product, and utilities in accordance with cGMP requirements.
• Conduct bioburden, bacterial endotoxin, and environmental monitoring testing.
• Carry out cleanroom, isolator, and biosafety cabinet monitoring as part of the environmental monitoring program.
• Perform utility sampling including water systems.
• Prepare, qualify, and perform growth promotion testing of microbiological media.
• Perform identification of microorganisms isolated during routine testing.
• Support method verification, method transfer, and validation activities as required.
• Perform receipt, logging, and processing of samples for microbiological testing.
• Accurately complete all laboratory documentation, records, and reports in compliance with data integrity and GMP standards.
• Ensure full compliance with SOPs, specifications, and regulatory requirements.
• Support investigations of out-of-specification (OOS), out-of-trend (OOT), and environmental monitoring excursions.
• Participate in media fills, aseptic qualifications, and contamination control activities.
• Maintain a high standard of housekeeping, safety, and good laboratory practices.
• Contribute to continuous improvement in laboratory setting.
• Support cross-functional departments as required to meet manufacturing and quality objectives.
• Perform any other duties as assigned by the Microbiology Supervisor/Manager.

Qualification & Experience preference:

• Minimum of a Level 8 degree in Microbiology or related discipline is required.
• 1 – 5 years’ experience in a pharmaceutical / healthcare laboratory or related technical function.
•  A strong background in Microbiology and aseptic technique is desirable and experience working with isolators is advantageous.
• Sterility experience is desirable but not essential.
• Experience in HPLC and UV Spectrophotometry, Bioburden and Endotoxin testing is desirable.
• Experience using any of the laboratory software – MODA, CIMS, LIMS, LES and Veeva Vault or similar.
• The successful candidate must demonstrate excellent written and verbal communication skills.
• The ability to work in a team based collaborative environment is essential.
• Candidate are required to be open to work a shift pattern.

Note:

• Due to the nature of the business additional duties may be assigned from time to time.
• All applicants must be eligible to work in Ireland.
• All applicants must be willing to work in shifts, as it may be required to work a shift pattern.

Apply Now

If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you. Please send your CV to: [email protected]

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