GMP QC Analyst – Lab Testing & Equipment Calibration

Johnson & Johnson Co.; Cork; On-site; EUR 39,000 - 55,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a QC Analyst to join Janssen Sciences Ireland (JSI) to execute analytical testing, method validation, and equipment qualification in a GMP environment. The role requires 3+ years in a biologics/pharma lab and familiarity with ICH, CFR, USP, and EP guidelines.

You will train others, write SOPs, and ensure timely test results while maintaining cGMP standards. The contract runs for 12 months with a competitive hourly rate.

Qualifications

• Third level qualification in a scientific/technical discipline required.
• A minimum of 3 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.

Responsibilities

• Achieves competency in JSI 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 so as to ensure that all methods meet ICH, CFR 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 so as 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 and WIs as directed by company policy.
• Ensures QC activities are carried out in compliance with product licence 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 Team Leader and Manager.
• Anticipates and plans for future requirements in the area.
• Deals with non-conformances/ deviations in an accurate and timely manner.
• Deputizes for the QC Team Leader as appropriate.
• Maintains and develops knowledge of analytical technology as well as cGMP standards.
• Bioassay testing and Cell Culture.

Skills

Laboratory testing experience

Regulatory knowledge (FDA/EMEA)

Analytical techniques

Education

Bachelor's degree in scientific/technical discipline

Job description

Johnson & Johnson Innovative Medicine is seeking a QC Analyst to join Janssen Sciences Ireland (JSI) to execute analytical testing, method validation, and equipment qualification in a GMP environment. The role requires 3+ years in a biologics/pharma lab and familiarity with ICH, CFR, USP, and EP guidelines.

You will train others, write SOPs, and ensure timely test results while maintaining cGMP standards. The contract runs for 12 months with a competitive hourly rate.