Senior MSAT Deviation Investigator

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

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, MSAT Investigations in Bothell, WA to lead deviation investigations ensuring regulatory compliance and timely CAPA closure. The role collaborates with QA Reviewer/Approver, SMEs, and stakeholders to define plans and gather data for root-cause analyses.

The position emphasizes cross-functional teamwork, rigorous documentation, and effective communication to drive quality improvements in manufacturing and laboratory investigations within the

Qualifications

• Bachelor’s degree in relevant Science or Engineering is required.
• 5+ years of relevant cGMP experience, FDA/EMA regulation preferred.
• Minimum of 2 years working with quality systems managing deviation and CAPA records.

Responsibilities

• Actively manages deviations to achieve RFT and on-time phase completion, including deviation closure by the original due date.
• Partners with investigation team on definition and alignment of the investigation plan, required data, and timing for completion.
• Facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements.
• Ensures smooth transition of CAPA to the owning department SME and timely implementation.
• Leads GEMBAs and interviews personnel to identify failure modes and gain understanding of deviations.
• Applies Human and Organizational Performance (HOP) principles to investigations.
• Demonstrates teamwork and communication with internal and external customers.
• Understands the deviation and CAPA processes including all phases and asset-lot relationships.
• Attaches all necessary supporting evidence to deviations and ensures referenced attachments.

Skills

GMP compliance

Cross-functional collaboration

Written and verbal communication

Root cause analysis

CAPA management

Data collection

Education

Bachelor’s degree in relevant Science or Engineering

Job description

Bristol Myers Squibb is seeking a Senior Specialist, MSAT Investigations in Bothell, WA to lead deviation investigations ensuring regulatory compliance and timely CAPA closure. The role collaborates with QA Reviewer/Approver, SMEs, and stakeholders to define plans and gather data for root-cause analyses.

The position emphasizes cross-functional teamwork, rigorous documentation, and effective communication to drive quality improvements in manufacturing and laboratory investigations within the