QC Technical Expert - Microbiology

Location: Barnahely, Cork

Contract: Full Time/Permanent

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Job Summary

We have an exciting opportunity for a QC Technical Expert on a permanent basis.

The responsibilities & the impact YOU will have:

• Supports Team leader on day to day testing operations.
• Performs Data and QC Investigations review and approval.
• Reviews Specifications and plans for associated LIMS scheduling.
• Reviews and approves deviations, CAPA’s, Change Control.
• Plans and oversees lab related projects, ie., Method transfers, Equipment Qualification etc.
• Proactively identifies and drives lab process improvements
• Trains laboratory team on specific analytical technology.
• Provides subject matter expert technical support on specific analytical technology.
• Supports lean initiatives in the area of lab operations, ie., test method execution, documentation updates and equipment qualification etc.
• Presents technical analytical clearly and concisely data to customers, internal investigations and regulatory inspectors, etc.
• Keeps abreast of analytical technology and compliance trends

Qualifications

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

• Bachelor’s Degree in Chemistry or related field.
• 4-6 years related experience in biopharmaceutical or pharmaceutical industry, And/or an equivalent combination of education and experience.
• Working knowledge of regulatory requirements, policies and guidelines.
• Experience with Quality Control document reviews and regulatory inspection processes.
• Working knowledge of Quality systems.
• Strong technical knowledge in and experience with QC analytical testing methods and equipment is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required

This is what awaits YOU at J&J:

This is an opportunity to work with a ground-breaking biomedicine operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.

We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.

Whether you’re one of the people who already work here, or you’re considering joining the team, we offer:

• An opportunity to be part of a global market leader.
• A dynamic and inspiring working environment.
• Opportunities to work on challenging projects and assignments.
• Possibilities for further personal and professional development/education
• Excellent Benefits