On-Site QA Operations Specialist (Shopfloor)

Bristol-Myers Squibb; Leiden; On-site; EUR 52,000 - 70,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Specialist, QA Operations Shopfloor to oversee quality on the factory floor within manufacturing, QC, warehouse and packout operations in Leiden. This on-site, shift role requires adherence to cGMP and strong collaboration with cross-functional teams.

The candidate will assess discrepancies, approve deviations, and participate in internal and external inspections while supporting newer team members and continuous improvement efforts.

Qualifications

• Bachelor’s degree in engineering or sciences, preferred.
• 0-2 years of relevant cGMP experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Experience with quality management systems preferred.

Responsibilities

• Provide Quality on-the-floor oversight to Manufacturing, QC, Warehouse and Packout operations.
• Identify departures from approved procedures & respond to issues independently, escalating more complex issues.
• Independently assess discrepancies for entry into quality system and approve deviations, as applicable.
• Perform and document operational verification per approved procedures.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Provide quality oversight to maintenance operations and support pre-approved return to service plans.
• Perform area walkthroughs to identify quality issues and support implementation of remediation.

Skills

Quality oversight

cGMP experience

Manufacturing floor

Communication skills

MS Office

Education

Bachelor’s degree in engineering or sciences

High school diploma/Associate degree

Tools

MES

ERP

Job description

Bristol Myers Squibb Netherlands is seeking a Specialist, QA Operations Shopfloor to oversee quality on the factory floor within manufacturing, QC, warehouse and packout operations in Leiden. This on-site, shift role requires adherence to cGMP and strong collaboration with cross-functional teams.

The candidate will assess discrepancies, approve deviations, and participate in internal and external inspections while supporting newer team members and continuous improvement efforts.