Quality Control Analyst

At Johnson &Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow,and profoundly impact health for humanity.Learn more at As guided by Our Credo, Johnson &Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Ringaskiddy, Cork, Ireland

Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for the Quality Control Analyst position to be in Cork, Ireland.

Purpose: This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures at CBIL as required by Good Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.

As a Quality Control Analyst, you will:

• Achieve competency in CBIL laboratory methods and procedures.
• Trains other QC analysts in laboratory methods and procedures when required.
• Perform 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.
• Execute validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
• Write, executes, reports and reviews IQ/OQ and PQ protocols so as to ensure that all relevant equipment is qualified for cGMP use.
• Perform routine and non-routine analytical testing activities.
• Review and approval (where appropriate) of laboratory test results.
• Ensure that testing and results approval are completed within agreed turnaround times.
• Write and reviews laboratory TMs, SOPs and WIs as directed by company policy.
• Ensure 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.

Qualification/Requirements:

• A third level qualification in a scientific/technical discipline required.
• 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.

Required Skills:

• Collaboration
• Customer-Focused
• Innovation
• Problem Solving
• Strategic Thinking

Preferred Skills:

• Analytical Reasoning
• Business Behavior
• Compliance Management
• Continuous Improvement
• Controls Compliance
• Data Analysis
• Execution Focus
• ISO 9001
• Persistence and Tenacity
• Quality Control (QC)
• Quality Control Testing
• Quality Standards
• Quality Systems Documentation
• Report Writing
• Sample Testing
• Technologically Savvy

The anticipated base pay range for this position is: €42,400.00 - €67,965.00

Benefits:

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions.
• vacation days
• parental leave for a minimum of 12 weeks
• bereavement leave
• caregiver leave
• volunteer leave
• well-being reimbursement
• programs for financial, physical and mental health.
• service anniversary and recognition awards
• participation in several insurance plans (subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate)
• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Additional information: 42,400 - 67,965 At Johnson &Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow,and profoundly impact health for humanity.Learn more at