Night-Shift Shop Floor QA Specialist – cGMP Focus

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

Benefits offered by this job

Comprehensive benefits

Flexible Time Off (FTO)

11 paid holidays

Job summary

Bristol Myers Squibb Co in Summit, NJ seeks a Specialist QA Shop Floor to provide on-the-floor quality oversight across Manufacturing, QA Labs, Label Operations and Warehouse Operations. You will ensure compliance with cGMP, review records, and support deviation handling while fostering a culture of quality.

The role requires 2+ years of cGMP experience, a STEM degree, and strong problem-solving and communication skills.

Qualifications

• Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking.
• Ability to understand, follow, and apply internal policies, procedures, and quality principles.
• Prior experience with quality processes, including batch record review, change control, product complaints, deviations, investigations, and CAPA management.
• Ability to assess unfolding situations, diagnose problems, and propose practical solutions.
• Detail-oriented and task-focused with the ability to meet deadlines and prioritize work.
• Ability to work in a fast-paced team with changing priorities and limited information.

Responsibilities

• Provide on-the-floor quality oversight and triage unexpected events with Manufacturing, Quality Labs, Label Operations and Supply Chain.
• Interpret problems and communicate clearly to management and the group.
• Identify departures from procedures and escalate complex issues.
• Perform and document MES verifications per procedures.
• Observe cleanroom operations and aseptic techniques.
• Support pre-planned return-to-service activities.
• Conduct area walkthroughs to identify quality issues and plan remediations.
• Review batch records for compliance and feedback on documents.

Skills

Decision-making

Relationship building

Problem solving

Analytical thinking

Quality principles

Cross-functional communication

Policy understanding

Education

Bachelor's degree in STEM

2+ years cGMP experience

Tools

MES

SAP

LIMS

Electronic logbooks

Job description

Bristol Myers Squibb Co in Summit, NJ seeks a Specialist QA Shop Floor to provide on-the-floor quality oversight across Manufacturing, QA Labs, Label Operations and Warehouse Operations. You will ensure compliance with cGMP, review records, and support deviation handling while fostering a culture of quality.

The role requires 2+ years of cGMP experience, a STEM degree, and strong problem-solving and communication skills.