QA Investigator

Location:
**Zwijnaarde**
**#22096**

Will you be our new ambassador?

**Jefferson Wells Life Sciences** specializes in supporting **pharma & biotech companies** in their daily challenges. Hence our interest in **experts** like you to join our team.

Let's look together at your first challenge with us

**QA investigator**

**Scope of work**:

- You collaborate with the site personnel to provide guidance and determine resolution for manufacturing issues.
- You ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
- You perform analysis on quality indicating data and identifying trends.
- Yu collaborates with functional departments to resolve issues.
- You manage cross-functional projects with many stakeholders.
- You perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- You require mínimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.
- You provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
- You routinely recognize and resolve quality issues. Seek management guidance on complex issues. You drive continuous improvement.

**Profile**:

- You hold a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
- You have minimum of 4 years relevant work experience is required.
- You have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
- You have strong interpersonal and written/oral communication skills.
- You have ability to quickly process complex information and often make critical decisions with limited information.
- You are able to pay attention to details and follow the procedures.
- You must be ighly organized and capable of working in a team environment with a positive attitude under some supervision.
- You have good written and verbal communication skills.
- You have a technical knowledge of Dutch and English
- You are able to summarize and present results, and experience with team-based collaborations is a requirement.
- You are able to work with others in a team environment.
- You have knowledge and understanding of current cGMP and current cGTP related to CAR-T manufacturing or cell processing.
- You are able to identify/remediate gaps in processes or systems. with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.

**What can Jefferson Wells do for you?**

As an ambassador you have the opportunity to grow within international companies where you can build a **strong network**. Through a personal **follow-up**, you receive **quality support** in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal **training** and **education**.