At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs and change control. May support authoring of APQR sections for QC.
Duties/Responsibilities
- ✓Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs and change control.
- ✓Work with QC SMEs to conduct root cause analysis. Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls.
- ✓Generate and report KPIs. Highlight and escalate at risk items. Analyze and report CAPA effectiveness.
- ✓Own document revision, project, CAPA and deviation/investigation, change management and/or continuous improvement efforts.
- ✓Train and mentor others on deviation, investigation, CAPA and change control process/procedures.
- ✓Represent department in internal/ external inspections.
- ✓May support authoring of APQR sections.
- ✓Communicate effectively with management and cross functional teams (e.g., present investigation findings at governance forums).
Qualifications
Specific Knowledge/Skills/Abilities
- ✓Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- ✓Advance problem-solving ability/mentality, critical thinking, technically adept and logical.
- ✓Advance ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
- ✓Ability to work in a fast-paced team environment, action oriented, highly organized to meet deadlines and prioritize work.
- ✓Strong mentoring, coaching, influencing, negotiating and personnel interaction skills.
Education/Experience/Licenses/Certifications
- ✓Bachelor’s degree in science, engineering, or related discipline.
- ✓6+ years of experience in biopharmaceutical or QC lab operations with 2+ years of prior investigation experience required. An equivalent combination of education and experience may substitute.
- ✓Knowledge of cell therapy analytical and microbiological testing preferred.
- ✓Demonstrated experience with Quality management systems.
- ✓Demonstrated strong technical writing skills.
- ✓Demonstrated experience in laboratory or biomanufacturing. investigations and root cause analysis techniques preferred.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Bothell - WA - US: $108,280 - $131,212