On-Site QA Operations Specialist (Shopfloor)

Bristol Myers Squibb; Leiden; On-site; EUR 40,000 - 60,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Specialist, QA Operations Shopfloor to ensure compliance with cGMP across Manufacturing, QC and Warehouse operations. This on-site, shift role emphasizes accurate quality oversight on the floor and effective collaboration with cross-functional teams.

You will review records, approve deviations where appropriate, participate in inspections, and support continuous improvement in a fast-paced biopharma environment.

Qualifications

• Bachelor's degree in engineering or life/physical sciences preferred.
• 0-2 years of related cGMP experience; biopharma or cell therapy manufacturing preferred.
• Experience with quality management systems.
• Experience with electronic systems and databases such as MES/ERP preferred.

Responsibilities

• Provide on-the-floor quality oversight to Manufacturing, QC, Warehouse and Packout operations.
• Identify departures from approved procedures & responding to issues independently and escalating more complex issues to senior members.
• 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 of pre-approved return to service plans.
• Perform area walkthroughs to identify quality issues, propose remediations and support implementation to ensure the floor and operations are in adherence with cGMP and approved procedures.
• Review manufacturing or testing records to ensure compliance with approved procedures.
• Communicate and resolve discrepancies independently and elevate as required.
• Author and review department owned documents.
• Maintain compliance with assigned learning plan.
• Support integration of newer team members.
• Support internal and external inspections as required.
• Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/ knowledge within team.
• Build relationships with specialized function

Skills

QA oversight

cGMP knowledge

MS Office

Communication

Problem solving

Teamwork

Education

Bachelor's degree in engineering or life science

Tools

MES

ERP

Job description

Bristol Myers Squibb Netherlands is seeking a Specialist, QA Operations Shopfloor to ensure compliance with cGMP across Manufacturing, QC and Warehouse operations. This on-site, shift role emphasizes accurate quality oversight on the floor and effective collaboration with cross-functional teams.

You will review records, approve deviations where appropriate, participate in inspections, and support continuous improvement in a fast-paced biopharma environment.