Analyst Quality Control

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

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 https://www.jnj.com/innovative-medicine 

We are searching for the best talent for a an Analyst Quality Control to be in Cork.

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.

Your responsibilities:



* Perform and review analytical testing (routine, non-routine, method validation, and technical transfer) ensuring compliance with ICH, CFR, USP, and EP guidelines.


* Validate and maintain laboratory equipment, including calibration, troubleshooting, and qualification (IQ/OQ/PQ) for cGMP use.


* Prepare and review documentation such as SOPs, work instructions, test methods, and validation protocols in line with company policies and regulatory standards.


* Train and support QC analysts, deputize for the QC Team Leader, and actively contribute to QC group activities.


* Ensure timely review and approval of test results, manage deviations/non-conformances, and maintain compliance with product license commitments and cGMP.


* Stay updated on analytical technologies and regulatory standards, anticipating future requirements for continuous improvement

Qualifications and requirements:



* 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.


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At Johnson & Johnson, we want every candidate to feel supported throughout the h...