Quality Control Analyst IP

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:
IE004 Barnahely

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

Job Description:

We are searching for the best talent for the Quality Control Analyst role to be in Cork, Ireland.

Purpose:

The QC analyst role 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.

You will be responsible for:


* Achieves competency in 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 to ensure that all methods meet ICH, 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 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, TMDs and WIs as directed by company policy.


* Ensures QC activities are carried out in compliance with product license 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 Specialist, QC Team Leader and Manager.


* Deals with Quality Issues in an accurate and timely manner.


* Maintains and develops knowledge of analytical technology as well as cGMP stan...