On-the-Floor QA Specialist — Night Shift

Bristol-Myers Squibb Company; Summit (NJ); On-site; USD 48,000 - 58,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Paid vacation

Global Shutdown

Job summary

Bristol Myers Squibb in Summit, NJ is seeking a Quality Assurance Shop Floor professional to oversee 24x7 operations, ensuring compliance with cGMP and site policies across Manufacturing, QC Labs, Label Operations and Warehouse.

The role emphasizes on-the-floor QA oversight, deviation handling, batch record review and collaboration with cross-functional teams. Candidates should have cGMP experience, cleanroom familiarity and strong analytical, communication and problem-solving skills.

Qualifications

• Bachelor's degree in STEM field.
• 2+ years of relevant cGMP experience with 1+ years of manufacturing site experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Responsibilities

• Provide routine quality on-the-floor oversight and triage events.
• Interpret problems and communicate clearly to management.
• Review batch records and documents for compliance.
• Perform MES verifications and deviations within QMS.
• Maintain learning plans and onboard new teammates.
• Act as AP release for Summit markets if required.

Skills

Decision-making

Problem-solving

Analytical thinking

Communication

GxP knowledge

Fast-paced teamwork

Documentation

Training others

Education

Bachelor's degree in STEM

High school/Associate equivalent

Tools

MES

SAP

LIMS

Electronic logs

Tableau

Power Automate

Smartsheet

Job description

Bristol Myers Squibb in Summit, NJ is seeking a Quality Assurance Shop Floor professional to oversee 24x7 operations, ensuring compliance with cGMP and site policies across Manufacturing, QC Labs, Label Operations and Warehouse.

The role emphasizes on-the-floor QA oversight, deviation handling, batch record review and collaboration with cross-functional teams. Candidates should have cGMP experience, cleanroom familiarity and strong analytical, communication and problem-solving skills.