QA Release Specialist

QA Release Specialist ensures quality oversight of cell therapy production.

Job Description

The QA Release Specialist role at Legend Biotech involves providing quality oversight for the production of personalized cell therapy in a sterile GMP environment. They will review paper and electronic batch records related to the manufacturing of viral vectors and autologous CAR-T products for clinical trials and commercial operations.

Role Involves:

Reviewing documentation for manufacturing activities.
Executing batch record reviews for commercial, development, and engineering production.
Contributing to process improvement of batch records.
Collaborating within Manufacturing to resolve batch record discrepancies.
Implementing corrective and preventive actions.
Driving compliance and reducing non-conformances.

Requirements:

A minimum of a Bachelor’s Degree in Science, Information Science, or equivalent technical discipline.
A minimum of 4 years of relevant work experience.
Experience working in an aseptic manufacturing facility is preferable.
Knowledge of cGMP regulations and FDA/EU guidance.
Strong interpersonal and communication skills.
Ability to make critical decisions with limited information.
Great attention to detail and ability to follow procedures.
Good written and verbal communication skills.
Flexibility to work on weekends as needed.
Dutch and technical English language skills.

The Role Offers:

Opportunity to work in a cGMP cleanroom environment.

Involved in clinical and commercial personalized cell therapy.

Opportunity to implement corrective and preventive actions.

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