Night-Shift Quality Assurance Specialist

Regulatory Jobs; New Jersey; On-site; USD 48,000 - 58,000; Full time

Job summary

Bristol Myers Squibb is seeking a Specialist QA Shop Floor to provide 24x7 quality oversight across manufacturing, QC labs, and warehouse operations at our New Jersey site.

Responsibilities include reviewing batch records, deviations, CAPA, and ensuring adherence to cGMP. The role requires hands-on quality control, strong communication, and collaboration with cross-functional teams in a fast-paced environment.

Qualifications

• Bachelor's degree in STEM field; equivalent experience considered.
• 2+ years of cGMP experience with 1+ year manufacturing site exposure.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
• Experience with quality processes: batch record review, deviations, CAPA management.

Responsibilities

• Provide on-the-floor quality oversight and triage events with manufacturing and quality labs.
• Interpret problems and communicate findings clearly to management.
• Identify deviations from procedures and escalate when needed.
• Perform MES verifications per approved procedures.
• Observe cleanroom operations and aseptic techniques.
• Review batch records for compliance and provide feedback on documents.

Skills

Action-oriented decisions

Communication

Problem-solving

Analytical thinking

Policy adherence

Fast-paced teamwork

Cross-functional communication

Active listening

Detail-oriented

Data-driven decisions

Quality-culture advocate

Education

Bachelor's degree in STEM

2+ years cGMP experience

FDA/EMA biopharma experience

Tools

MES

SAP

LIMS

Electronic logbooks/forms

Power Automate

Smartsheet

Tableau

Job description

Bristol Myers Squibb is seeking a Specialist QA Shop Floor to provide 24x7 quality oversight across manufacturing, QC labs, and warehouse operations at our New Jersey site.

Responsibilities include reviewing batch records, deviations, CAPA, and ensuring adherence to cGMP. The role requires hands-on quality control, strong communication, and collaboration with cross-functional teams in a fast-paced environment.