Night-Shift QA Shop Floor Specialist — Deviation & Compliance

Bristol Myers Squibb; Harvard (MA); On-site; USD 55,000 - 66,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing & Health programs

401(k) and financial protection

Job summary

Bristol Myers Squibb is seeking a Specialist, QA Shop Floor for the Devens, MA site. This role leads quality decision-making during night shifts, triaging production events and ensuring adherence to cGMP on the shop floor.

You will review batch records, support deviations, and collaborate with Manufacturing, Quality Labs, and Supply Chain to maintain product quality and compliance across operations.

Qualifications

• Bachelor’s degree in STEM or equivalent with cGMP exposure.
• 2+ years of relevant cGMP experience in manufacturing environments.
• Experience with quality records, deviations, CAPA and change control.

Responsibilities

• Provide on-the-floor quality oversight and triage unexpected events with Manufacturing and QA labs.
• Interpret issues clearly and communicate with management and teams.
• Identify deviations from procedures and escalate as needed.
• Review batch records and QC data for compliance and accuracy.
• Support site inspections and cross-functional quality initiatives.
• Maintain access to and SME knowledge of QA systems and MES/SAP/LIMS.

Skills

Decision-making

Problem-solving

Analytical thinking

Communication

Team collaboration

Attention to detail

GxP knowledge

Education

Bachelor’s degree in STEM

Tools

MES

SAP

LIMS

VEeva

DeltaV

Maximo

Job description

Bristol Myers Squibb is seeking a Specialist, QA Shop Floor for the Devens, MA site. This role leads quality decision-making during night shifts, triaging production events and ensuring adherence to cGMP on the shop floor.

You will review batch records, support deviations, and collaborate with Manufacturing, Quality Labs, and Supply Chain to maintain product quality and compliance across operations.