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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

Position Title:

Specialist, QA Shop Floor - Warehouse

Location:

Cell Therapy Operations (CTO), Summit West, New Jersey

PURPOSE AND SCOPE OF POSITION:

The Specialist, QA Shop Floor – Warehouse, is responsible for quality activities supporting Warehouse Operations in accordance with Bristol-Myers Squibb policies, standards, procedures and Global cGMPs. Functional responsibilities include ensuring GMP warehouse compliance with applicable procedures, providing real-time review of warehouse records and logbooks, and working with Warehouse Operations to resolve issues. Experience in gowning into classified environments and the ability to support manufacturing areas is required.

QASF-Warehouse is also responsible for supporting the warehouse in daily commercial and clinical patient material receiving and shipping activities for multiple CAR T products.

Warehouse areas covered include S12 Warehouse Receiving, Dispensary, Apheresis and Cryo-Rooms and Shipping, the S6A Warehouse, the S16 Supply Center and other areas as needed.

This position supports 24/7 manufacturing operations with support provided on all holidays and shifts.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Customer Focus:

• Ability to complete routine tasks with moderate direction; consults management for advice on complex issues, confident in making decisions for minor issues.
• Ability to follow technical reports or data that affects quality of materials, such as environmental/temperature tracking.
• Must be fluent in speaking and writing English, following Good Documentation Practices.
• Understands continuous improvement and contributes to improving efficiency and productivity within the group or project.
• Builds relationships internally within the immediate team and with cross functional teams.
• Contributes to goals within the work group.

Patient Focus:

• Must have at least a basic knowledge of and experience in FDA-regulated cGMP Quality Warehousing operations and processes.
• Supports Quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues, informs management of proposed solutions, and seeks management guidance on complex issues.
• Able to recognize and work through conflict and elevate to management when required.

Passion for the Role:

• Must possess an independent mindset. Work may be self-directed.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Confident in presenting solutions for non-routine issues.
• Contributes to the development and revision of procedures.
• Ability to interpret results and situations and articulate recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.

Education and Experience:

• High School Degree Required.
• Relevant college or university degree preferred.
• Preferred minimum of 2-3 years relevant work experience, with at least one (1) year in a Quality Assurance or QA Shop Floor role.
• Understanding of Oracle, SAP, or other ERP system desired.
• Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

• Wednesday to Saturday
  mid-shift (1:30PM-12AM), subject to change
  10 hours/day

• Perform QA Shop Floor activities with a focus on Warehouse Operations, such as oversight of patient material receipt, storage and shipments, raw materials handling and inventory accuracy, cleaning and kitting operations.
• Daily activities may involve being gowned for up to 4 hours at a time.
• Perform GMP Walk-Throughs of warehouse areas.
• Oversee Apheresis, PBMC and CMAT receiving and Drug Product Shipping for clinical and commercial lots.
• Build and maintain relationships with Warehouse Operations, Quality Control, Manufacturing, Supply Chain and other departments to effectively accomplish responsibilities, make improvements and resolve issues.
• Ensure compliance with GMPs, Good Documentation Practices, applicable procedures and warehouse requirements for storage, documentation, material handling, safe equipment operation, etc.
• Perform real-time review of warehouse records and logbooks.
• Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant manner.
• Supports or works with other departments in reviewing and providing input to deviations, change controls, procedures, investigations, CAPAs and work orders.
• Author and review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.
• Uphold and support quality processes, including material disposition, material storage and handling requirements, change controls, product complaints, deviations, investigations, CAPA management.
• Use eQMS to document deviations and CAPAs; use eDMS to review, revise or approve SOPs and/or other controlled documents; use ERP systems to change lot status or perform other data entry; other systems as applicable.

• Must be flexible with working hours and able to work weekends and off hours as needed to support the patient.

WORKING CONDITIONS (US Only):

Work is performed in a combination of warehouse and office environments, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 50% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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 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.