Quality Specialist

Quality Specialist 

Location: Full remote working (you must be based in BE to be considered for this position)

Duration: 12 months

Hours: 40 per week

Imagine your next project working for Johnson & Johnson Innovative Medicine as a Quality Specialist. Working as a support associate for external quality. Responsible for providing support to the account manager through review of batch and validation documentation, assessment of deviation investigation, CAPAs and change requests, completion of release packages and management of routine issues to ensure the highest levels of quality and compliance for JJIM Biologics products.

roles and responsibilities

• Support the External Quality account owner in providing QA oversight support on External Manufacturers in the EQ LM EMEA network.

• Contribute to the ongoing technology transfers, inspection readiness, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical large molecules products.

• Support day-to-day quality oversight for production activities, including but not limited to:

• Identification of quality risks, 

• deviation and CAPA management, including coordination and writing of investigations

• Complaint handling, 

• Coordinate, review and approve Change control activities

• Perform batch documentation review and coordinate batch release activities.

• Review of Technology Transfer documentation e.g.: qualification protocols and reports, master batch records.

• Handle Regulatory Requests

• Review CPV and PQR reports

• Batch Tracking activities

• Initiate MDLDs in a Quality System and coordinate requirements with QP

• Ensure that all relevant QA related concerns at the external manufacturer’s sites are raised to the External Quality Account Owner.

how to succeed

• Knowledge of the requirements for the production and release of Biologics products in the EU and associated countries, and in-depth knowledge of deviation management processes. 

• A minimum of 5 years working in an FDA or similar regulated environment; Quality Assurance experience preferred. 

• A minimum of 3 years experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production). 

• Strong interpersonal and written/oral communication skills. 

• Proficient in applying process excellence tools and methodologies. 

• English mandatory, other languages are a benefit. 

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

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”.