QC Analyst

QC Analyst

Location: Cork

Duration: 12 months

Hours: 4 12 hour shifts, 2 days, 2 nights and 4 off

Imagine your next project partnering with other Departments to ensure that all QC testing activities are completed in an efficient manner at an iconic global healthcare company.

Position Title: QC Analyst Department Name: Quality Control Reports To: QC Team Leader

Position Summary: 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.

Significant Environmental, Health & Safety considerations: All employees are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual. In line with the Safety Health & Welfare at Work Act (2005), all employees are required to: Take reasonable care to protect their own and the safety of their colleagues who may be affected by their actions. Comply with EHS rules and procedures at all times. Understand the potential EHS impact of their activities Attend and participate in EHS training as required Use PPE and safety equipment as required. Report all incidents, accidents, and near miss events. Report unsafe plant, equipment, acts, procedures or issues Make suggestions to improve health and safety in the workplace. Actively participate in work area EHS teams. Not turn a ‘blind eye’ to unsafe acts or situations.

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.

• 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.

• Note: A waiver may be granted in exceptional circumstances for individuals who are not performing those tasks requiring the above qualifications and experience. This would be at the discretion of the QC Team Leader in conjunction with QC Manager.

• Facilitate an environment of continuous improvement

• Collaboration and teamwork

• Strategic Thinker

• Credo value of integrity

• To work as a strategic partner with all other departments within the company

• Interface with all site departments as required.

• Excellent interpersonal skills

• Ability to operate as part of a team is critical.

• Customer focus

• Innovative

• Excellent communication skills both written and verbal

• Attention to detail

• Good problem solving skills

• Results and performance driven

• Adaptable and flexible

• 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 run for 12 months

you are welcome here

Johnson & Johnson 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 or LinkedIn InMail - you must apply direct to this advert.

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”.