Senior MSAT Investigations Specialist

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

Benefits offered by this job

Comprehensive benefits

Flexible time off (FTO)

11 paid holidays

Job summary

Bristol Myers Squibb seeks a Deviation Investigator within the MSAT team at the JuMP site in Bothell, WA. The role focuses on investigating deviations to determine root cause, CAPAs, and ensuring regulatory-compliant reports, collaborating with QA, SMEs, and stakeholders.

Ideal candidates have 5+ years in cGMP environments, strong technical writing, and experience with quality systems and deviation management.

Qualifications

• Bachelor’s degree in Science or Engineering required.
• 5+ years of relevant cGMP experience; FDA/EMA regulation experience preferred.
• Experience managing deviation and CAPA records.
• Strong written and verbal communication skills; ability to work cross‑functionally.

Responsibilities

• Manages deviations to achieve right-first-time and on-time closure.
• Collaborates with QA, SMEs, and stakeholders to define investigation plan and data needs.
• Leads CAPA teams to define objectives, deliverables, ownership, and due dates.
• Ensures CAPA is transferred to owning department and tracked to timely implementation.
• Performs root cause analyses and leverages RCA tools; identifies failure modes and improvement actions.

Skills

GMP compliance

FDA/EMA regulations

Cross-functional collaboration

Technical writing

Root cause analysis

CAPA processes

Investigations

Data analysis

Education

Bachelor’s degree in Science or Engineering

Job description

Bristol Myers Squibb seeks a Deviation Investigator within the MSAT team at the JuMP site in Bothell, WA. The role focuses on investigating deviations to determine root cause, CAPAs, and ensuring regulatory-compliant reports, collaborating with QA, SMEs, and stakeholders.

Ideal candidates have 5+ years in cGMP environments, strong technical writing, and experience with quality systems and deviation management.