Specialist, QA Shop Floor

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The QA Shop Floor Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues. 12 hours shift with split week including one weekend day.

Shift Available:

• Wednesday to Saturday, alternating every other Wednesday off, onsite, 5:00 a.m. to 5:30 p.m.

Responsibilities:

• Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities make improvements and resolve issues.

• Ensure manufacturing compliance with applicable procedures and batch records.

• Perform real time review of manufacturing batch records.

• Review manufacturing shop floor documentation.

• Issue production batch records and product labels to Operations.

• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

Knowledge & Skills:

• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

• Must be skilled in planning and organizing, decision-making, and building relationships.

• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

• Must be able to work in the cleanroom environment for 6-hour time periods.

• Must be available for weekend and off-shift hours.

• Must be flexible for shift hour changes to support manufacturing.

• Must have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes.

• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

• Must possess an independent mindset.

• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.

• Work is self-directed.

• Confident in making decisions for non-routine issues.

• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.

• Develops procedures.

• Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.

• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.

• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem