QC Investigator

Do you have a strong quality mindset and a passion for investigating deviations and driving continuous improvement? As we continue to expand our operations in Ghent, we are looking for a QC Investigation Specialist;

What can you expect?

As a QC Investigation Specialist, you are responsible for managing QC-related deviations and executing qualitative investigations in close collaboration with cross-functional stakeholders. You play a key role in ensuring thorough root cause analysis and defining corrective and preventive actions to reduce future non-conformances. You are responsible for;

QC Investigations & Deviation Management

• Reviewing and completing QC non-conformance/deviation investigationsin time.
• Performing root cause analyses usingappropriate investigationtools and methodologies.
• Interviewing cross-functional stakeholders andprovidingquality input to complete investigation reports.
• Acting with a high sense of urgency in response to departmental and cross-functional requests.

Documentation & Technical Writing

• Documenting QC non-conformance/deviation investigations with detail and clear technical writingjargon.
• Performing all tasks in compliance with GMP requirements, qualitysystems,and safety policies.
• Supporting inspection readiness and interacting confidently with auditors and inspectors.

Problem Solving & Continuous Improvement

• Proactively collaborating with internal stakeholders to define, implement and ensuretimelycompletion of effective CAPA’s.
• Monitoring and reporting metrics related to investigations and CAPA performance.
• Providing recommendations for process improvements by workingcross-functionally.

Who are we looking for?

Education

• You obtained aBachelor'sdegree orequivalentrelevant experience.

Experience

• You have hands-on experience in a GMP environment, preferably in quality control.

Languages

• You are fluent in English and/or Dutch.

Strengths

• You havestrongcommunicationskills that foster collaboration.
• You have a solution-oriented mindset prioritizing quality and compliance.
• You are able to act quick and feel a strong sense of urgency.
• You are able to stay calm and motivated under tight deadlines.
• You arecurious and dive deep to find out the root cause of a problem andcanthink out-of-box when defining improvements and solutions.
• You have strong documentation skills.

What do we offer you?

• A meaningful job with an excellent work-life balance, in a40-hourwork week working fromMonday until Friday.
• A supportive and innovative work environment . We value and encourage learning and personal development.
• The opportunity to work with people from all over the world.
• A contract of indefinite duration and an attractive salary package complemented by many fringe benefits, such asadditionalstatutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus.
• Many fun and informal events.

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer.

The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent:Obelisc(Technology ParkZwijnaarde) and Tech Lane (EilandjeZwijnaarde).

In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson .

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.

You can find more information about how we collect, use, and protect your personal data for recruitment purposes, including your rights under applicable data protection laws, in our Candidate Privacy Notice here: https://legendbiotech.eu/en/candidate-privacy-noti