Shopfloor QA Operations Specialist

Bristol-Myers Squibb Co

Leiden

On-site

EUR 42,000 - 56,000

Full time

14 days+

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Job summary

Bristol Myers Squibb Netherlands seeks a Specialist, QA Operations Shopfloor to provide on-the-floor quality oversight across Manufacturing, QC, and Warehouse to ensure cGMP compliance. This on-site, shift role requires collaboration with multiple teams to uphold quality standards and timely issue resolution.

The ideal candidate has a background in engineering or life sciences, 0–2 years in cGMP, and experience with quality systems.

Qualifications

Bachelor's degree in engineering or life sciences preferred; high school diploma/associate degree with equivalent experience acceptable.
0-2 years of relevant cGMP experience; experience in biopharmaceuticals or cell therapy manufacturing preferred.
Experience with quality management systems preferred.
Experience with MES and ERP systems is preferred.

Responsibilities

Provide on-the-floor quality oversight to Manufacturing, QC, Warehouse and Packout operations.
Identify departures from approved procedures and escalate complex issues to senior staff.
Assess discrepancies for entry into quality systems and approve deviations as applicable.
Perform and document operational verification per approved procedures.
Observe manufacturing operations and ensure adherence to clean room and aseptic techniques.
Support maintenance operations and approved return-to-service plans.
Conduct area walkthroughs to identify quality issues and support remediation.
Review manufacturing or testing records for compliance with procedures.
Communicate and resolve discrepancies and escalate as required.
Author and review department-owned documents.