QC Analyst

QC Analyst Microbiology

Location: Barnahely, Cork

Working mode: On-site

Duration: 12 months

Hours: 4 cycle shift pattern

This position 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.

roles and 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.

how to succeed

• A third level qualification in a scientific/technical discipline required (ideally Microbiology)

• A minimum of 1-2 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.

• The ideal candidate would have experience of Endotoxin, Bioburden, Environmental monitoring, Sterility testing or aseptic training

key competencies

• Builds strong productive relationships

• Demonstrates ability to work with teams and individuals

• Asserts personal ideas and opinions using persuasion to influence others

• Seeks opportunities to grow and develop professionally

• Uses best practices to improve business operations

• Holds self accountable for compliant and flawless execution

• Takes personal responsibility for decisions that successfully build customer value

• Effectively manages and adapts to change

• Demonstrates the courage to stand alone on ideas and opinions that differ from others

• Listens effectively and remains open to other’s ideas.

• Works effectively with people that have diverse styles, talents and ideas

• Maintains the highest standards of ethical behaviour

• Treats people with dignity and respect

benefits

This role offers a very competitive hourly rate. This contract will initially run for 12 months.

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.