QA Associate

This position will be based at our Geel site in Belgium.

Change lives for the better.

THE OPPORTUNITY

Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a QA Associate - QA Lab (M/F/X) as member of our Quality team overseeing the Quality Control laboratories Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product Intermediates based in Geel, Belgium.

J&J Innovative Medicine Supply Chain Geel serves as Center of Excellence for the development and manufacturing of SM-API’s and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. At J&J Innovative Medicine Supply Chain Quality (IMSCQ) we support the Geel site in its mission as Launch & Grow site and we are responsible for the quality oversight and final release of SM-API’s and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.

As QA Associate - QA Lab, you have quality oversight of the Quality Control laboratories, responsible for testing of final API, API intermediates, Raw Materials and Packaging Materials as well as Drug Product Intermediates. In this role you report to the Senior QA Manager.

The responsibilities & impact YOU will have:

- Establishing and maintaining strong working relationships with your partners in Quality Control (QC) laboratories as well as commercial and clinical Supply Chain.
- Acting as QA Point of Contact for the QC laboratories ensuring compliance with global regulations and J&J quality requirements.
- Supporting the quality oversight process of the operational activities by ensuring QA review and approval of GMP documentation.
- Handling of lab related deviations by:

- Supporting experts in finding root causes
- Defining, following up and concluding corrective and preventive actions.
- Evaluating trends in issue investigations and defining appropriate actions.
- Approving analytical method transfers.
- Ensuring that quality records such as investigations, CAPA’s, Change Controls, analytical method transfer protocols and reports related to the QC area are timely and properly handled by providing quality, compliance and technical expertise such that the internal and external customer expectations are met.
- With focus on Quality processes, develop and foster an environment of innovative thinking through e.g. benchmark and training. Continuously challenge the status quo by finding opportunities for continuous improvement.
- Acting as spokesperson during Health Authority inspections and customer audits.
- Ensuring that deviations and complaints with potential impact on patient safety and/or product supply are properly escalated.

**Qualifications**:
We would love to hear from YOU, if you have the following essential requirements:
To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment. Further requirements include:

- Master Scientific degree with a technical specialization in analytics/chemistry/biotechnology (or equivalent through experience).
- Experience in Chemical and/or Pharmaceutical Quality Control and/or Quality Assurance is an asset
- In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
- Strong analytical thinking skills and able to work in a flexible way under time pressure in local and global teams. Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.
- We are looking for someone who works accurately and proactively seeks solutions and who has the necessary communication skills.
- You speak and write Dutch and English fluently.

Closing date: Friday, 15th of November 2024.

Being part of Johnson & Johnson can change everything, including YOU

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 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”