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QUALIFICATIONS / REQUIREMENTS:

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

PURPOSE:

The QC analyst role is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures at Janssen Sciences Ireland (JSI) as required by Good Manufacturing Practice (GMP). Partners with other departments to ensure that all QC testing activities are completed in an efficient manner.

You will be responsible for:

• Achieves competency in laboratory methods and procedures.
• Trains other QC analysts in laboratory methods and procedures when required.
• Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.
• Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
• Writes, executes, reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
• Performs routine and non-routine analytical testing activities.
• Review and approval (where appropriate) of laboratory test results.
• Ensures that testing and results approval are completed within agreed turnaround times.
• Writes and reviews laboratory TMs, SOPs, TMDs and WIs as directed by company policy.
• Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
• Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Specialist, QC Team Leader and Manager.
• Deals with Quality Issues in an accurate and timely manner.
• Maintains and develops knowledge of analytical technology as well as cGMP standards.
• In process control testing and activities to support the production units.