QC Compliance Scientist — Cell Therapy Investigations & CAPA

Biopharma Careers; Bothell (WA); On-site; USD 108,000 - 131,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Global Shutdown between Christmas and

Health & dental benefits

Job summary

BMS in Bothell, WA is seeking a Scientist, QC Compliance to lead and author QC deviations, investigations and CAPAs for cell therapy programs. You will own deviations, investigation reports, change controls, and contribute to APQR sections as needed.

You will work with global regulatory standards, perform root cause analysis, mentor staff, and represent the department during inspections, delivering KPI reports and ensuring timely closure of quality events.

Qualifications

• Knowledge of global regulatory and cGMP requirements.
• Strong technical writing skills.
• Experience with quality management systems.
• Laboratory/biomanufacturing investigations and root cause analysis preferred.

Responsibilities

• Lead and author QC deviations, investigations, CAPAs and change control.
• Work with QC SMEs to conduct root cause analysis.
• Ensure timely, compliant closure of investigations and CAPAs.
• Generate and report KPIs and escalation of at-risk items.
• Train and mentor others on deviation, investigation, CAPA and change control processes/procedures.
• Represent department in inspections.

Skills

Regulatory compliance

CAPA investigations

Root cause analysis

Documentation/writing

Cross-functional communication

Education

Bachelor's degree in science/engineering

Job description

BMS in Bothell, WA is seeking a Scientist, QC Compliance to lead and author QC deviations, investigations and CAPAs for cell therapy programs. You will own deviations, investigation reports, change controls, and contribute to APQR sections as needed.

You will work with global regulatory standards, perform root cause analysis, mentor staff, and represent the department during inspections, delivering KPI reports and ensuring timely closure of quality events.