MSAT Investigations Lead - Deviation & CAPA Expert

Bristol-Myers Squibb Co; Bothell (WA); On-site; USD 91,000 - 110,000; Full time

Benefits offered by this job

Flexible Time Off

Comprehensive benefits

11 paid holidays

Job summary

Bristol Myers Squibb in Bothell, WA is seeking a Senior Specialist for MSAT Investigations to lead deviation investigations, root cause analyses, and CAPA campaigns at JuMP. You will collaborate with QA, SMEs, and cross-functional partners to ensure timely, compliant investigations and deviation closures.

Qualifications include a Bachelor’s degree in science or engineering and 5+ years of cGMP experience; FDA/EMA knowledge is preferred.

Qualifications

• Bachelor’s degree in science or engineering or equivalent.
• 5+ years of relevant cGMP experience.
• Experience with FDA/EMA regulations preferred.

Responsibilities

• Actively manages deviations to achieve right first time (RFT) and on-time phase completion.
• Leads investigation/CAPA teams to define objectives, ownership, due dates, and effectiveness requirements.
• Performs root cause analyses and CAPA verification to reduce trends and improve quality.
• Applies Human and Organizational Performance (HOP) principles to investigations and writes thorough reports.

Skills

GMP compliance

cGMP experience

Cross-functional collaboration

Strong communication

Attention to detail

Education

Bachelor's degree in science/engineering

Job description

Bristol Myers Squibb in Bothell, WA is seeking a Senior Specialist for MSAT Investigations to lead deviation investigations, root cause analyses, and CAPA campaigns at JuMP. You will collaborate with QA, SMEs, and cross-functional partners to ensure timely, compliant investigations and deviation closures.

Qualifications include a Bachelor’s degree in science or engineering and 5+ years of cGMP experience; FDA/EMA knowledge is preferred.