QA Shopfloor Specialist – Cell Therapy (Onsite, Shift)

Biopharma Careers; Leiden; On-site; EUR 70,000 - 90,000; Full time

Job summary

The Sr. Specialist, QA Operations Shopfloor at Bristol Myers Squibb Leiden leads quality activities on the Cell Therapy Facility floor, ensuring cGMP compliance and real time review of batch records.

Based on-site in Leiden, the role requires strong documentation skills, cross‑functional collaboration, and the ability to resolve manufacturing issues while maintaining strict quality standards. This is a shift-based, on-site position with no remote work.

Qualifications

• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Must have sound knowledge and experience in regulated cGMP warehousing, Quality, and compliance environments.

Responsibilities

• Perform QA shopfloor activities.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing shopfloor documentation.
• Must be able to interpret results and generate technical conclusions consistent with quality risk management principles.
• Routinely recognizes and resolves Quality issues; informs management of proposed solutions.

Skills

Action‑oriented

Decision making

Building relationships

Problem solving

Planning and organizing

Analytical thinking

Education

Bachelor's degree in engineering or life/physical science

Job description

The Sr. Specialist, QA Operations Shopfloor at Bristol Myers Squibb Leiden leads quality activities on the Cell Therapy Facility floor, ensuring cGMP compliance and real time review of batch records.

Based on-site in Leiden, the role requires strong documentation skills, cross‑functional collaboration, and the ability to resolve manufacturing issues while maintaining strict quality standards. This is a shift-based, on-site position with no remote work.