In Process Control Quality Control Analyst

Johnson & Johnson is currently seeking for an In Process Control Analyst, in Little Island, 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/

What you will be doing:

This position is responsible for supporting Operational requirments on a Shift basis carrying out tasks and projects related to Manufacturing Equipment Cleaning/Changeover and testing procedures at Janssen Pharmaceuticals Ireland 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:


* Provide cross functional support and expertise to onsite cleaning processes - cleaning logs, protocol & report review/approval.


* Perform cleaning analysis including but not limited to monitoring, evaluation and validation, in particular swabbing, inspections, residue on evaporations, insoluble matters and analysis of swabs of production equipment including final sign off of equipment cleaning logs.


* Performs routine and non-routine analytical testing activities.

Initiates and support NC's as part of this process.


* Trains other QC analysts in laboratory methods and procedures when required.


* Executes validation testing in line with Technical Operations , operation, maintenance, calibration and troubleshooting of equipment and its associated software.


* 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 directed by company policy.


* Ensures QC activities are carried out in compliance with product licence commitments, cGMP and company quality standards.


* Deals with non-conformances/ deviations in an accurate and timely manner.


* 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:


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


* A minimum of 3 years experience in a laboratory-testing environment within the 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 productive relationship.


* Demon...