Job Information
Bristol Myers Squibb Sr. Specialist, Quality Assurance Operations in Summit, New Jersey
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 Sr Specialist, QA Operations Deviation role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.
Shift Available:
- Wednesday - Saturday, Onsite, 4 p.m. - 2 a.m.
Responsibilities:
Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
Review all data in accordance with applicable procedures and cGMP requirements.
Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.
Train new analysts to general job duties.
Support document revision, project, CAPA, and investigation/deviation related tasks.
Perform assigned tasks within a CAPA, deviation, or project.
Participate in projects and continuous improvement efforts.
Perform other tasks as assigned.
Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions.
Ability to adapt to multiple changing priorities.
Knowledge & Skills:
Must have advanced knowledge and experience with US and global cGMP manufacturing, Quality, and Compliance.
Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.
Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
Must provide guidance to other employees in the interpretation of technical/scientific issues.
Must possess an independent mindset and tenacity.
Confident in making decisions for minor issues.
Basic Requirements:
Bachelor's degree required, preferably in science-based field.
3 years of minimum within a manufacturing GMP environment.
2+ years of relevant within a Quality role (either QA/QC).
Expert level experience with technical writing.
Preferred Requirements:
Advanced degree, in a science area.
5 years Quality Control and/or Quality Assurance experience in a pharmaceutical company with CAR T or Biologics experience.
Knowledge of LIMS and laboratory data analysis systems.
Support in Health Authority Inspections.
Ability to understand the manufacturing process of both Abecma and Breyanzi.
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/ 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.
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: R1582884
Updated: 2024-08-21 05:19:37.166 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.
Bristol Myers Squibb
-
- Bristol Myers Squibb Jobs