QC Technical Expert (Technical Team)

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:
Business Enablement/Support

All Job Posting Locations:
Ringaskiddy, Cork, Ireland

Job Description:

Position Title: QC Technical Expert
Department Name: Quality Control
Reports To: QC Team Lead

Job Description

Position Summary:
We are seeking a highly skilled QC Technical Expert with a strong technical background in analytical techniques, particularly in Microbiology, and a solid understanding of laboratory equipment.

This individual will play a vital role in ensuring the quality and compliance of our biopharmaceutical processes.

Key Responsibilities:


* Qualify analytical equipment and oversee related testing functions.


* Coordinate sampling and testing during plant and utility qualifications.


* Plan and manage the successful transfer of Analytical Methods for new market entries (NMEs).


* Oversee the analytical testing and sampling of raw materials, utilities, in-process, final bulk, and final products.


* Support and implement training programs for analysts.


* Contribute to end-to-end product launches and new product introduction (NPI) commitments to maintain high standards in operations.


* Serve as the lead for method verification related to product owner requests, ensuring on-time launches for NPIs.

Collaborate with various departments and team leaders to ensure efficient completion of QC activities.

General Scope of Responsibilities:


* Assist the team leader with daily testing operations.


* Review and approve data and QC investigations.


* Assess and approve deviations, CAPAs, and Change Control.


* Plan and oversee laboratory projects, such as method transfers and equipment qualifications.


* Identify opportunities for lab process improvements and implement them proactively.


* Train laboratory staff on specific analytical technologies.


* Provide subject matter expert support on analytical technologies.


* Participate in lean initiatives focused on lab operations, advancing documentation and qualification processes.


* Present analytical data clearly to customers, regulatory inspectors, and internal teams.


* Stay current with emerging trends in analytical technology and compliance.

Key Competencies Required:


* Strong collaboration and teamwork abilities.


* Strategic and analytical thinking.


* Exceptional problem-solving skills and atten...