Quality Assurance Specialist

Quality Assurance Specialist

Location: Little Island, Cork, - Mainly site based

Duration: 12 months

Hours: 39 per week - Days role

Imagine your next project working as a Quality Assurance Specialist for Johnson & Johnson Innovative Medicine. 

roles and responsibilities

• Batch Record Review and material release (includingCoA) to ensure compliance with GMP requirements. 

• Quality review and approval of Master Batch Record (MBR) record for routine cleaning and process activities, including Automation recipe updates. 

• QA Review and Approval of SOPs, Work Instructions and  forms from other departments. 

• Attendance at Daily/Weekly Operations led Team Meetings. 

• Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a QA perspective. 

• QA review and approval of Warehouse Shipping Picklist. 

• Primary QA point of contact for Quarantine Shipments. 

• Responsible for Batch Book Filing & Archival. 

• QA review and approval of quality non-conformance  (NC) records and customer complaint non-conformance records. 

• Initiation and ownership of QA non-conformance records. 

• Responsible for periodic review of Quality Assurance and Quality Systems SOPs. 

• Primary Quality point of contact for attendance at Root Cause Analysis meetings. 

• Primary QA point of contact for the Returns process. 

how to succeed

Skills and Competencies Required: 

• Builds strong productive relationships. 

• Demonstrates ability to work with teams and individuals. 

• Seeks opportunities to grow and develop professionally. 

• Uses best practices to improve business operations. 

• Holds self-accountable for compliant and flawless execution. 

• Takes personal responsibility for decisions that successfully build customer value. 

• Effectively manages and adapts to change. 

• Always demonstrate Integrity and Credo-based actions. 

• Ability to work independently, manage their own time and meet deadlines as appropriate. 

Education and Experience: 

• Third level Degree in a science or pharmaceutical discipline. 

• A minimum of 3 years of experience within the Pharmaceutical Industry or related discipline. 

• A working knowledge of quality processes and systems is desirable. 

• Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. 

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months 

you are welcome here

Johnson & Johnson is 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.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

The pay rate for this role will depend on how you are paid. 

Diversity, Equity & Inclusion

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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each 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”.