Quality Control Analyst – Bioassay

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 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.

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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 are searching for the best talent to join us as a Quality Control Analyst Bioassay at Janssen Sciences Ireland (JSI) in Ringaskiddy Cork Ireland.

Purpose
In this role you will be responsible for carrying out Quality Control laboratory activities related to bioassay testing laboratory utilities and equipment in compliance with Good Manufacturing Practice (GMP). You will partner closely with crossfunctional teams to ensure QC testing activities are executed efficiently compliantly and in alignment with regulatory expectations and company quality standards. Through this work you support product quality regulatory compliance and continuous improvement across the site. You will need to achieve and maintain competency in JSI laboratory methods procedures and bioassay technologies and training other QC analysts when required. Environmental Health & Safety compliance is essential - you will need to comply with the companys Environmental Health & Safety Policy Safety Statement associated EHS procedures local legislation and duties outlined in the site EHS Manual.

You will be
Performing routine and nonroutine analytical and bioassay testing including method validation and technical transfer activities in line with ICH CFR USP and EP guidelines
Executing validation operation maintenance calibration and troubleshooting of laboratory equipment and associated software
Writing executing reporting reviewing and approving IQ/OQ/PQ protocols to ensure equipment is qualified for cGMP use
Reviewing and approving laboratory test results (where appropriate) and ensuring testing and approvals are completed within agreed turnaround times
Writing and reviewing laboratory Technical Manuals (TMs) SOPs and Work Instructions (WIs) in accordance with company policies
Managing nonconformances and deviations accurately and in a timely manner ensuring compliance with product licence commitments cGMP and company quality standards
Acting as an active member of the QC group by supporting team activities communicating issues to the QC Team Leader and Manager deputising when required and contributing to future planning and continuous improvement initiatives

Qualifications / Requirements
A thirdlevel qualification in a scientific or technical discipline
A minimum of 2 years experience in a laboratory testing environment within the biological and/or pharmaceutical industry
Demonstrated knowledge and testing experience in an FDA / IMBapproved QC laboratory
Knowledge of FDA and EMEA regulatory requirements applicable to biologics and/or pharmaceuticals
Strong written and verbal communication skills
Strong attention to detail problemsolving ability and analytical thinking
Ability to work effectively in a collaborative crossfunctional environment
A results and performancedriven adaptable and flexible approach

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:
Application review: Well carefully review your CV to see how your skills and experience align with the role.
Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
Final steps: For successful candidates you will need to complete countryspecific checks before starting your new role. We will help guide you through these.

Finally at the end of the process well invite you to share feedback in a short survey your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. Were excited to learn more about you and wish you the best of luck in the process!

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following 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. Moreover we offer 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. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.