Cell Therapy Investigations Specialist — CAPA Lead

Bristol Myers Squibb; Harvard (MA); On-site; USD 83,000 - 100,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off (FTO)

11 paid holidays

Global Shutdown

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Specialist, Investigations, Cell Therapy to lead and support deviation investigations in a cGMP cell therapy manufacturing environment.

You will draft investigation reports and CAPAs, coordinate with Manufacturing, QA, Quality Control, Engineering, and other teams, and drive CAPA effectiveness while ensuring compliance with internal procedures and regulatory requirements.

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline with 1–3 years’ biopharma ops experience.
• Familiarity with CAPA systems and quality documentation.
• Strong attention to detail and ability to manage multiple priorities.

Responsibilities

• Lead and support deviation investigations and CAPAs in a cGMP cell therapy environment.
• Draft investigation reports and CAPAs with accuracy and compliance.
• Document investigation activities and coordinate with manufacturing, QA, QC, engineering.
• Support CAPA tracking, scheduling and effectiveness verification.
• Contribute to continuous improvement and stay current with regulatory expectations.

Skills

Investigation processes

CAPA systems

Attention to detail

Communication

MS Office

Quality systems

Quality Risk Management

Education

Bachelor's degree in science/engineering/biochemistry or related discipline

Job description

Bristol Myers Squibb in Devens, MA is seeking a Specialist, Investigations, Cell Therapy to lead and support deviation investigations in a cGMP cell therapy manufacturing environment.

You will draft investigation reports and CAPAs, coordinate with Manufacturing, QA, Quality Control, Engineering, and other teams, and drive CAPA effectiveness while ensuring compliance with internal procedures and regulatory requirements.