QA Shopfloor Specialist, Cell Therapy Ops

Bristol-Myers Squibb; Netherlands; Remote; EUR 70,000 - 95,000; Full time

Job summary

Bristol Myers Squibb Netherlands in Leiden seeks a Sr. Specialist, QA Operations Shopfloor to ensure quality on the Cell Therapy Facility floor.

This on-site role supports cGMP compliance, real time review of batch records, and investigations, aligning with global quality standards. The ideal candidate has a bachelor's in engineering or science and 4+ years of cGMP experience, including manufacturing site exposure.

Qualifications

• Bachelor's degree in engineering, life or physical science related field preferred.
• 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.

Responsibilities

• Perform QA shopfloor activities.
• Ensure manufacturing compliance with procedures and batch records.
• Perform real time review of manufacturing batch records and logbooks.
• Review manufacturing shopfloor documentation.
• Authorship and critical review of investigations and technical conclusions per quality risk management principles.
• Plan, organize and build relationships across functions.

Skills

QA Operations

cGMP

Documentation

Investigations

Cross-functional teamwork

Decision making

Education

Bachelor's degree in engineering or science

Job description

Bristol Myers Squibb Netherlands in Leiden seeks a Sr. Specialist, QA Operations Shopfloor to ensure quality on the Cell Therapy Facility floor.

This on-site role supports cGMP compliance, real time review of batch records, and investigations, aligning with global quality standards. The ideal candidate has a bachelor's in engineering or science and 4+ years of cGMP experience, including manufacturing site exposure.