Senior QA Investigations Specialist - CAPA Leader

Bristol-Myers Squibb Co; Bend (OR); On-site; USD 84,000 - 102,000; Full time

Benefits offered by this job

Comprehensive benefit plans

Flexible Time Off (FTO)

11 paid company holidays

Additional time-off benefits

Global Shutdown between Christmas and

Job summary

Bristol Myers Squibb is seeking a Quality Assurance professional for a regulated manufacturing environment. You will review investigations, CAPAs, and effectiveness checks, and approve technical reports to support deviations and risk assessments.

Key duties include ensuring robust corrective actions, supporting inspections, and delivering training content while collaborating with cross-functional teams to maintain compliance and data integrity.

Qualifications

• Bachelor's degree in STEM field preferred.
• High school diploma/Associates degree with equivalent combination of education and work experience may be considered.
• 4+ years of experience in a regulated industry with 1+ year deviation experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated experience with electronic system and databases.
• Demonstrated experience in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.

Responsibilities

• Review and approve investigations/ CAPAs / effectiveness checks.
• Review, approve technical reports, including risk assessments and deviation system monitoring reports.
• Ensure corrective/preventive actions and Effectiveness Check plans address root cause.
• May perform routine reporting and analysis of metrics.
• Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
• Support internal and external inspections as required.
• Maintain compliance with assigned learning plan.
• Support development and delivery of training content to cross functional teams.
• Lead meetings and represent function at cross functional meetings.
• Share data/ knowledge within and across team.
• Build & maintain strong relationships with partner functions.

Skills

Regulatory guidelines

MS Office

Smartsheets

Data interpretation

Technical writing

Problem solving

Education

Bachelor's degree in STEM

High school diploma/Associate degree

Tools

MS Office

Smartsheets

Electronic systems

Job description

Bristol Myers Squibb is seeking a Quality Assurance professional for a regulated manufacturing environment. You will review investigations, CAPAs, and effectiveness checks, and approve technical reports to support deviations and risk assessments.

Key duties include ensuring robust corrective actions, supporting inspections, and delivering training content while collaborating with cross-functional teams to maintain compliance and data integrity.