QA Investigations Specialist: Deviation & CAPA Oversight

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

Benefits offered by this job

Flexible Time Off

Paid holidays

Comprehensive benefits

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, QA Investigations at the Summit Cell Therapy Facility in Summit, NJ. The role provides quality oversight for deviations, CAPAs, and effectiveness checks, ensuring compliance and robust corrective actions in a fast-paced manufacturing environment.

The incumbent will review investigations, risk assessments, and technical reports while supporting inspections, training, and cross-functional collaboration. Onsite day shift availability.

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.

Responsibilities

• Review and approve investigations, CAPAs and effectiveness checks for manufacturing site.
• Review and approve technical reports (risk assessments and deviation monitoring) to support deviations program.
• Ensure CAPA and Effectiveness Check plans robustly address root causes.
• May perform routine reporting and analysis of metrics to ensure timely closure of quality events.
• Identify improvement opportunities and support continuous improvement goals.
• Support internal and external inspections.
• Maintain compliance with learning plan; support training content development and delivery.
• Lead meetings and represent function at cross functional meetings.
• Share data and knowledge within and across teams.
• Build and maintain strong relationships with partner functions.

Skills

Quality investigations

CAPA knowledge

Regulatory guidelines

Data analysis

Technical writing

Cross-functional collaboration

Problem solving

MS Office

Smartsheets

Education

Bachelor's degree in STEM

High school diploma or Associate degree

Tools

Electronic systems and databases

MS Office

Job description

Bristol Myers Squibb is seeking a Senior Specialist, QA Investigations at the Summit Cell Therapy Facility in Summit, NJ. The role provides quality oversight for deviations, CAPAs, and effectiveness checks, ensuring compliance and robust corrective actions in a fast-paced manufacturing environment.

The incumbent will review investigations, risk assessments, and technical reports while supporting inspections, training, and cross-functional collaboration. Onsite day shift availability.