At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
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.
Summary:
The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Supply Chain Operations.
This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
Shift Available:
6am – 6pm, rotating (panama) schedule including holidays and weekends
Responsibilities:
• Provide Quality on-the-floor oversight to Manufacturing/ QC/ Supply Chain Operations & responding to minor issues or escalating to senior members.
• Perform and document operational verification per approved procedures.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Provide quality oversight to maintenance operations and support pre-approved return to service plans.
• Perform area walkthroughs to identify quality issues and support remediation to ensure the floor and operations are in adherence with cGMP and approved procedures.
• Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies and escalate as required.
• Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
• Maintain compliance with assigned learning plan.
• Support internal and external inspections as required.
• Contribute to the assessment of discrepancies and initiation of quality events. • Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/ knowledge within team.
• Build relationships within direct team and partner functions.
Knowledge & Skill:
• Ability to understand, follow, and apply approved procedures
• Possess basic computer skills with knowledge of MS Office
• Ability to understand problems and propose practical solutions
• Ability to communicate effectively with cross functional peers and direct management through written and verbal skills
• Ability to work in a fast-paced team environment with changing priorities.
• Detail oriented and task focused, with the ability to meet deadlines and prioritize assigned work.
• Ability to recognize the need for escalation of issues.
• Self-motivated and willingness to learn
Basic Requirement:
• Bachelor's degree in STEM field preferred. High school diploma/ Associates
degree with equivalent combination of education and work experience may be considered.
• 0-2 years of relevant cGMP experience. Experience in FDA/EMA regulations
in biopharmaceuticals or cell therapy manufacturing is preferred.
Working Conditions:
Work is largely performed in a modern manufacturing facility where one must be aware of the presence of workplace standards including pressurized liquids gases, steam and hazardous chemicals.
Use of Personal Protective Equipment (PPE) will be required in some portions of the facility,…