Specialist, QC Analytical

Bristol Myers Squibb; Denville (NJ); On-site; USD 60,000 - 90,000; Full time

Job summary

Bristol Myers Squibb in Summit, NJ is seeking a Specialist to perform routine testing of in-process, final product, and stability samples in support of the Quality Control Analytical department at the CAR T Manufacturing facility. The role may include method transfer, validation, verification, and GMP documentation review.

Shift: Wed to Sat PM 1:30pm to 11:30pm. Candidates will contribute to data verification, CAPA and deviation investigations, and training of analysts as needed.

Responsibilities

• Perform routine testing of in-process, final product, and stability samples.
• May perform testing for method transfer/validation/verification.
• Perform data verification, data review and review of GMP documentation for general methods.
• May perform document revision, project, CAPA and deviation/investigation related tasks.
• Train analysts on general job duties.
• Perform other tasks as assigned.

Job description

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

The Specialist position is responsible for performing routine testing of in-process, final product, and stability samples in accordance with BMS policies, standards, procedures, and Global Regulatory and cGMP requirements to support the Quality Control Analytical department in the Bristol Myers Squibb (BMS) CAR T Manufacturing facility located in Summit, NJ. Additionally, this role may support testing for method transfer, validation, and verification as well as document revisions and supporting investigation related tasks.

Shift: Wed to Sat PM 1:30pm to 11:30pm

Duties and Responsibilities

• Perform routine testing of in-process, final product, and stability samples.
• May perform testing for method transfer/validation/verification.
• Perform data verification, data review and review of GMP documentation for general methods.
• May perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
• Train analysts on general job duties.
• Perform other tasks as assigned.

Safety Requirements and Essential Physical Demands

• Ability to lift up to 45 lbs at floor and waist height (commonly