Position Title QC Analyst Department Name Quality Control Reports To QC Team Leader Closing Date: 3rd October Johnson & Johnson Innovative Medicine Ringaskiddy are recruiting for a QC Analyst At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver significant solutions - depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we cultivate a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.
At Johnson & Johnson, we all belong 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.
General scope of responsibilities: * Achieves proficiency 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, implements, 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 advised 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.
Qualifications and experience: crucial: * 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.
Key individual contributor competencies: * Builds strong positive 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 expertly * Uses best practices to improve business operations * Holds self accountable for compliant and flawless execution * Takes personal responsibility for decisions that efficiently build customer value * Optimally handles 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 efficiently with people that have diverse styles, talents and ideas * Maintains the highest standards of ethical behaviour * Treats people with dignity and respect We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.
