On-Site QA Operations Specialist — Shopfloor

Bristol Myers Squibb EU Policy; Leiden; On-site; EUR 42,000 - 60,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Specialist, QA Operations Shopfloor to oversee quality on the floor across Manufacturing, QC, and Warehouse operations. This on-site, shift-based role ensures adherence to cGMP and approved procedures, with independent issue escalation and documentation responsibilities.

The position requires a 0–2 year background in cGMP environments, plus a degree in engineering or science.

Qualifications

• Bachelor's degree in engineering or life/physical science preferred; HS diploma/Associate’s degree acceptable.
• 0-2 years of relevant cGMP experience; FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.
• Experience with quality management systems; MES/ERP databases preferred.

Responsibilities

• Provide Quality on-the-floor oversight to Manufacturing, QC, Warehouse and Packout operations.
• Identify departures from approved procedures and respond to issues independently, escalating as needed.
• 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 propose remediations.
• Review manufacturing or testing records to ensure compliance with procedures.
• Communicate and resolve discrepancies independently and escalate as required.
• Author and review department owned documents.
• Maintain compliance with assigned learning plan.
• Support integration of newer team members and cross-department collaborations.

Skills

MS Office

Communication

Problem solving

Attention to detail

Education

Bachelor's degree in engineering or life/physical science

High school diploma or Associate’s degree with equivalent

Tools

MES

ERP

Job description

Bristol Myers Squibb Netherlands is seeking a Specialist, QA Operations Shopfloor to oversee quality on the floor across Manufacturing, QC, and Warehouse operations. This on-site, shift-based role ensures adherence to cGMP and approved procedures, with independent issue escalation and documentation responsibilities.

The position requires a 0–2 year background in cGMP environments, plus a degree in engineering or science.