QC Analyst – GMP Testing, Validation & Equipment

Johnson & Johnson; Cork; On-site; EUR 30,000 - 41,000; Full time

Job summary

Johnson & Johnson Janssen Sciences Ireland (JSI) seeks a QC Analyst to carry out testing procedures for GMP-compliant operations. The role involves validating methods, maintaining equipment, and supporting IQ/OQ/PQ activities while ensuring timely results and compliance with regulatory standards.

The successful candidate will have a third-level scientific qualification and at least 2 years' experience in a biopharma/regulated lab environment, with knowledge of FDA/EMEA guidelines and experience

Qualifications

• Third-level qualification in scientific/technical discipline required.
• Minimum 2 years' experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.
• Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.

Responsibilities

• Achieve competency in Janssen Sciences Ireland (JSI) laboratory methods and procedures.
• Train other QC analysts in laboratory methods and procedures when required.
• Perform analytical testing activities related to method validation and technical transfer to ensure methods meet ICH, CFR USP and EP guidelines.
• Execute validation, operation, maintenance, calibration and troubleshooting of equipment and associated software.
• Write, execute, report and review IQ/OQ and PQ protocols to ensure equipment is qualified for cGMP use.
• Perform routine and non-routine analytical testing activities.
• Review and approve laboratory test results where appropriate.
• Ensure testing and results approval are completed within agreed turnaround times.

Education

Third level qualification in scientific/technical discipline

Job description

Johnson & Johnson Janssen Sciences Ireland (JSI) seeks a QC Analyst to carry out testing procedures for GMP-compliant operations. The role involves validating methods, maintaining equipment, and supporting IQ/OQ/PQ activities while ensuring timely results and compliance with regulatory standards.

The successful candidate will have a third-level scientific qualification and at least 2 years' experience in a biopharma/regulated lab environment, with knowledge of FDA/EMEA guidelines and experience