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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 Sr. Specialist QA Shop Floor overseeing quality activities of the QA shop floor program in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.

Shift Available:

• Monday - Friday, Onsite Day Shift, 9 a.m. - 5:00 p.m.

Responsibilities:

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

• Ensure manufacturing, QC, and warehouse compliance with applicable procedures and batch records.

• Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations.

• Oversee Apheresis, PBMC and CMAT receiving and Cryopreserved Drug Product.

• Review executed records for documentation completeness and accuracy per ALCOA+.

• Support quality processes, including material disposition, material storage and handling requirements, change controls, product complaints, deviations, investigations, and CAPA management.

• 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 flexible for shift hour changes to support manufacturing.

Knowledge & Skills:

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

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

• 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.

Basic Requirements:

• Relevant college or university degree preferred. An equivalent combination of education and experience will be considered.

• A minimum 4 years of relevant experience within Quality Assurance within a manufacturing GMP facility.

• A minimum of 2 years hands-on experience in QMS.

• A minimum of 2 years of experience with risk assessments.

• 1 year of deviation experience.

• Strong project management experience.

BMSCART, #LI-Onsite

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1587690

Updated: 2024-11-30 05:20:19.286 UTC

Location: Summit West-NJ

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.