On-the-Floor Quality Assurance Specialist

Bristol Myers Squibb; Summit (NJ); On-site; USD 4,811,000 - 5,830,000; Full time

Benefits offered by this job

Flexible Time Off

Health insurance

Paid holidays

Stock opportunities

Job summary

Bristol Myers Squibb in Summit, NJ is seeking a Specialist QA Shop Floor to provide 24x7 quality collaboration across manufacturing, labs, and operations. You will oversee adherence to cGMP, manage deviations, and contribute to fix-and-improve initiatives for manufacturing, labeling, and supply chain.

Join a cross-functional team and support training, communications, and on-time release activities. This role emphasizes data-driven decision-making, risk management, and hands-on quality leadership

Qualifications

• Action-oriented with strong problem-solving and decision-making.
• Ability to follow internal policies, procedures, and quality principles.
• Experience with batch records, deviations, investigations, and CAPA.

Responsibilities

• Provide on-the-floor quality oversight and triage events with Manufacturing and Quality Labs.
• Interpret problems clearly and communicate effectively to management.
• Identify departures from procedures and escalate when needed.
• Verify operations in MES per approved procedures.
• Observe cleanroom operations and aseptic techniques.
• Approve deviations within the quality management system as allowed.
• Review batch records and quality documents for compliance.
• Support training and onboarding of new team members.
• Collaborate with core partner functions for quality solutions.
• Act as AP release performer for Summit markets when required.

Skills

Decision-making

Problem-solving

Communication

Analytical thinking

Quality systems

GxP knowledge

Cross-functional collaboration

Quick learning

Education

Bachelor's degree in STEM

2+ years of cGMP experience

Experience with FDA/EMA regulations

Tools

MES

SAP

LIMS

Electronic logbooks

Power Automate

Job description

Bristol Myers Squibb in Summit, NJ is seeking a Specialist QA Shop Floor to provide 24x7 quality collaboration across manufacturing, labs, and operations. You will oversee adherence to cGMP, manage deviations, and contribute to fix-and-improve initiatives for manufacturing, labeling, and supply chain.

Join a cross-functional team and support training, communications, and on-time release activities. This role emphasizes data-driven decision-making, risk management, and hands-on quality leadership