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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 Shop Floor Quality Assurance team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with Manufacturing/QC/Warehouse/Packout, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
Shifts Available: - Monday - Friday, Onsite Day Shift, 9 a.m. - 5:30 p.m.
Responsibilities: - Provide Quality on-the-floor oversight to Manufacturing/QC/Warehouse/Packout operations. Identify departures from approved procedures & responding to complex issues independently and escalating critical issues to management.
- May perform and document operational verification per approved procedures.
- Develops, reviews and/ or approves temporary and non-routine procedure for event response.
- Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
- Provide quality oversight to non-routine maintenance work where applicable.
- Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans.
- Own shift actions for departmental programs and propose improvements to programs.
- Participate in Gemba walks.
- Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies independently and escalate as required.
- Author, review, and approve procedural documents.
- Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel.
- May own training curriculum and content.
- May present individual topics during audits as needed.
- Independently assess discrepancies for entry into quality system and approve deviations as applicable.
- May serve as quality subject matter expert for risk assessments, change controls, etc.
- Lead meetings and represent function at cross functional meetings.
- Share data/knowledge within and across team. Build & maintain strong relationships with partner functions.
- May prioritize and assign tasks for the team.
Knowledge & Skills: - Demonstrated experience with quality management systems.
- Demonstrated experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP).
- Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
- Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications.
- Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
- Excellent written and verbal skills and ability to present technical data effectively based on target audience.
- Ability to work in a fast-paced team environment and lead peers through changing priorities.
- Detail oriented and task focused with ability to meet deadlines and support work prioritization.
- Ability to negotiate and influence to craft mutually beneficial solutions.
- Ability to motivate and foster a positive team environment.
- Exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
- Pioneering mindset and ability to create innovative solutions.
Basic Requirements: - Bachelor's degree in STEM field preferred. High school diploma/ associate's degree with equivalent combination of education and work experience may 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,
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 a supportive culture, promoting global participation 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 an 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 . Visit 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:
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Company: Bristol-Myers Squibb
Req Number: R
Updated: 2025-05-:11:17.303 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.