QC Compliance Scientist, Cell Therapy — Deviations & CAPAs

Bristol-Myers Squibb; United States; On-site; USD 108,000 - 131,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

11 paid holidays

Vacation time

Job summary

Bristol Myers Squibb in Bothell, WA is seeking a Subject Matter Expert to lead and author QC deviations, investigations, CAPAs, and change control. You will collaborate with QC SMEs to analyze root causes, ensure timely closure, and support governance activities.

Responsibilities include authoring APQR sections when needed, generating KPIs, and mentoring others on QC processes while representing the department during inspections.

Qualifications

• Ability to accurately understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Strong problem-solving, critical thinking and technical writing abilities.
• Excellent written and verbal communication with cross-functional teams.

Responsibilities

• Lead and author QC deviations, laboratory investigations, CAPAs and change control.
• Collaborate with QC SMEs to perform root cause analyses and timely closure.
• Generate and report KPIs; highlight and manage at-risk items; assess CAPA effectiveness.
• Own document revision, project, CAPA and deviation/investigation change management.
• Train and mentor others on deviation, investigation, CAPA and change control processes.

Skills

cGMP knowledge

Advanced problem solving

Effective communication

Organizational skills

Mentoring

Education

Bachelor's degree in science/engineering

Job description

Bristol Myers Squibb in Bothell, WA is seeking a Subject Matter Expert to lead and author QC deviations, investigations, CAPAs, and change control. You will collaborate with QC SMEs to analyze root causes, ensure timely closure, and support governance activities.

Responsibilities include authoring APQR sections when needed, generating KPIs, and mentoring others on QC processes while representing the department during inspections.