QC Batch Release Coordinator

TN Ireland; Connacht; On-site; EUR 45,000 - 55,000; Full time

Job summary

A leading CRO in Ireland is seeking a QC Officer Biologics to manage batch release testing and ensure compliance with GMP standards. The role requires expertise in cell and molecular biology, along with project management skills. Candidates should possess relevant scientific degrees and experience in a regulated environment. This permanent position offers a competitive salary and a comprehensive benefits package.

Qualifications

• At least 2 years of relevant experience in scientific research.
• Experience in GMP-regulated environment preferred.

Responsibilities

• Oversee routine batch release testing in the Biosafety and Cell-Based Assay Department.
• Generate and update GMP-compliant SOPs, protocols, and reports.
• Assist in internal, regulatory, and client visits/audits.

Skills

Project management

Education

BSc in a relevant science discipline

MSc in a relevant science discipline

Job description

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Join this thriving CRO as their next QC Officer Biologics.

They are looking for candidates with demonstrable cell and molecular-based experience.

This is a permanent role offering an attractive salary and a comprehensive benefits package, including many extras.

Responsibilities:

1. Oversee and manage routine batch release testing in the Biosafety and Cell-Based Assay Department, including client correspondence, weekly calls, management of subcontractors, ensuring samples are released within required timelines, scheduling tests, reviewing basic data, liaising with QA, and generating CoA.
2. Generate and update GMP-compliant SOPs, protocols, and reports.
3. Source, purchase, and stock consumables, standards, and reagents required for testing.
4. Receipt and processing of test samples in LIMS.
5. Carry out data calculations, basic statistics, and trending. Provide additional information to clients as required.
6. Assist in internal, regulatory, and client visits/audits and respond to findings.

Minimum Requirements:

• At least 2 years of relevant experience in scientific research, preferably within a GMP-regulated environment (EMEA/FDA) in the pharmaceutical, medical device, or CRO industry.
• Project management experience is desirable.
• BSc/MSc in a relevant science discipline (e.g., cell biology, molecular biology, biomedical science).
• Experience in cell-based assays/molecular techniques is desirable but not essential.

Please note: Applicants must have a Stamp 4 or unrestricted full working rights for Ireland.