Shop Floor QA Associate II: 24/7 Quality Oversight

Regulatory Jobs; Harvard (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Bristol Myers Squibb is seeking a Quality Assurance professional to oversee shop-floor operations, ensuring adherence to cGMP and company standards. The role collaborates with Manufacturing, QC, and Supply Chain to maintain quality and compliance.

Shift available from 6am to 6pm on a rotating schedule, including holidays and weekends, with a focus on continuous improvement and effective issue resolution across functions.

Qualifications

• Experience applying approved procedures in a manufacturing setting.
• Ability to document and communicate quality events clearly.
• Familiarity with FDA/EMA quality standards and regulatory expectations.

Responsibilities

• Provide on-the-floor QA oversight to Manufacturing, QC, and Supply Chain Operations.
• Perform and document operational verification per approved procedures.
• Identify deviations from clean room behaviors and aseptic techniques, escalating as needed.
• Provide quality oversight to maintenance operations and support return-to-service plans.
• Review manufacturing or testing records for compliance and resolve discrepancies.
• Participate in cross-department and cross-functional meetings, sharing data and knowledge.

Skills

Quality Assurance

cGMP

Aseptic techniques

Job description

Bristol Myers Squibb is seeking a Quality Assurance professional to oversee shop-floor operations, ensuring adherence to cGMP and company standards. The role collaborates with Manufacturing, QC, and Supply Chain to maintain quality and compliance.

Shift available from 6am to 6pm on a rotating schedule, including holidays and weekends, with a focus on continuous improvement and effective issue resolution across functions.