On-the-Floor Quality Assurance Specialist

Socket.dev; Bend (OR); On-site; USD 48,000 - 58,000; Full time

Job summary

Bristol Myers Squibb is hiring a Specialist QA Shop Floor to provide 24x7 quality oversight across manufacturing, labs, and supply chain, ensuring adherence to cGMP. You will interpret issues, verify processes, and support continuous improvement in a fast-paced environment.

Reporting to the Manager, Quality Assurance Shop Floor, the role requires strong communication, problem-solving, and collaboration with cross-functional teams. A STEM degree and 2+ years of cGMP experience are expected.

Qualifications

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

Responsibilities

• Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, Label Operations and Supply Chain operations.
• Interpret problems and communicate clearly to management and the group with accuracy.
• Identify departures from approved procedures and respond independently while escalating complex issues.
• Perform and document operational verification within MES per approved procedures.
• Review manufacturing batch records for compliance with procedures.
• Provide interpretation of technical conclusions of records/investigations and give feedback.
• Participate in quality and shift meetings and build cross-functional relationships.

Skills

Decision-making

Relationship-building

Problem-solving

Analytical thinking

Communication

Education

Bachelor's degree in STEM

Tools

MES

SAP

LIMS

Electronic logbooks

Power Automate

Smartsheet

Tableau

Job description

Bristol Myers Squibb is hiring a Specialist QA Shop Floor to provide 24x7 quality oversight across manufacturing, labs, and supply chain, ensuring adherence to cGMP. You will interpret issues, verify processes, and support continuous improvement in a fast-paced environment.

Reporting to the Manager, Quality Assurance Shop Floor, the role requires strong communication, problem-solving, and collaboration with cross-functional teams. A STEM degree and 2+ years of cGMP experience are expected.