QC Analyst - Separations

Johnson & Johnson is currently seeking an QC Analyst - Separations to join our Quality Control department located in Ringaskiddy, Co.

Cork.

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/.

Are you experienced in mastering laboratory methods and procedures? Are you passionate about mentoring and training others in laboratory techniques? Do you have a knack for ensuring compliance with industry standards like ICH, CFR, USP, EP, and cGMP?

What you will be doing:

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.

What impact you will also have:


* 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 as well as writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.


* Performs routine and non-routine analytical testing activities as well as review and approval (where appropriate) of laboratory test results.


* Ensures that testing and results approval are completed within agreed turnaround times and that 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.

We would love to hear from you, if you have the following required requirements:

Education:


* A third level qualification in a scientific/technical discipline requir...