NJ, US
5 days ago
Specialist, Quality Systems

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 Specialist for Quality Systems at the Summit, NJ Cell Therapy Manufacturing will be responsible for the CAPA, Deviation and System ownership. In this role, the incumbent will support the business process owner for the Complaint, CAPA and Deviation system and the associated governing local procedures and supporting processes, trending, metrics, and reports.  This is a visible role with site responsibility and cross-functional influence that has impact on departmental performance and broad quality system management. The incumbent will be the subject matter expert across the site.

Shift Available:

Monday - Friday, Hybrid Day Shift, flexible 8 a.m. - 5 p.m.

Responsibilities:

Manages the CAPA, Deviation, and Complaint Quality Systems for all GMP activities and works with responsible cross functional areas ensure timely completion.

Support the Complaint, and CAPA and Deviation Forums, generate meeting minutes, follow up on action items and facilitate resolution when required.

Compiles applicable process metrics, identifies trends and escalates accordingly.

SME support during internal and health authority inspections of facility.

Communicates effectively with cross functional stakeholders on matters related to change control process.

Supports Quality Systems harmonization, automation, and improvement projects.

Knowledge & Skills:

Must have experience with cGMP manufacturing, Quality, and Compliance.

Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions. 

Must have basic understanding of continuous improvement and be able improve the compliance and efficiency of the quality system.

Must be able to effectively prepare and convey data analysis insights to management and others within the group with clarity and accuracy.

Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes.

Requires moderate direction to complete more complex tasks

Comfortable providing input/guidance to others within the department and across the organization in change control technical writing.

Propose solutions for issues and work with management to resolve.

Comfortable providing training/guidance to system users as needed, and in instructor-led settings.

Able to recognize conflict and notify management with proposed recommendations for resolution.

Able to prepare written communications and communicate problems to management with clarity and accuracy.

Able to support internal and health authority inspections of facility.

Basic Requirements:

College or university degree. An equivalent combination of education and experience will be considered.

1 year Experience with deviations and CAPAs.

2 years Strong experience with pulling and compiling data.

1 year Data visualization or training experience (Ability to create slides and Infographics).

2 years of experience working in a cGMP environment.

Ability to multitask with competing priorities.

Preferred Requirements:

Familiarity with generating reports.

Experience supporting audits/inspections.

BMSCART, #LI-Hybrid

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/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/

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