Shop Floor Quality Assurance Specialist

Bristol Myers Squibb EU Policy; West Summit (UT); On-site; USD 48,000 - 58,000; Full time

Benefits offered by this job

Wellbeing support

Retirement and financial protection

11 paid holidays

Paid vacation

Global Shutdown

Job summary

Bristol Myers Squibb is seeking a Specialist QA Shop Floor to provide 24x7 quality oversight across manufacturing, labs, labeling, and supply chain. The role ensures adherence to cGMP and internal policies while coordinating with cross-functional teams to maintain product quality.

The position requires robust experience with quality systems, MES/SAP/LIMS, and a proactive approach to continuous improvement in a fast-paced pharmaceutical environment.

Qualifications

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

Responsibilities

• Provide on-the-floor quality oversight across Manufacturing, Quality Labs, Label Operations and Supply Chain.
• Interpret and communicate issues clearly to management and groups.
• Identify deviations from procedures and escalate as needed.
• Perform MES-based verifications per approved procedures.
• Maintain cleanroom and aseptic technique compliance.
• Oversee pre-planned return-to-service quality activities.
• Walkthrough areas to identify quality issues and propose remediations.
• Review batch records and quality documents for compliance.
• Maintain learning plans and integrate new team members.
• Approve deviation records within quality management system per risk principles.
• Interpret investigations and provide feedback.
• Participate in quality and shift meetings.
• Collaborate with core functions and promote quality culture.
• Act as designated AP release when required (PIC/S guidelines).
• Verify and reconcile issued drug product labels.

Skills

Action-oriented decision making

Policy comprehension

Quality processes

Problem solving

Detail oriented

Team collaboration

Data-driven decisions

Effective communication

Active listening

Quality culture champion

Quality risk management

Cleanroom operations

GxP systems experience

MES / ERP / LIMS familiarity

Power Automate / Smartsheet / Tableau

Education

Bachelor's degree in STEM

2+ years cGMP experience

FDA/EMA regulations experience

Tools

MES

SAP

LIMS

Electronic logbooks/forms

Job description

Bristol Myers Squibb is seeking a Specialist QA Shop Floor to provide 24x7 quality oversight across manufacturing, labs, labeling, and supply chain. The role ensures adherence to cGMP and internal policies while coordinating with cross-functional teams to maintain product quality.

The position requires robust experience with quality systems, MES/SAP/LIMS, and a proactive approach to continuous improvement in a fast-paced pharmaceutical environment.