Senior Quality Assurance Specialist, Shop Floor - Warehouse Operations Cell Therapy

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

The QA Shop Floor Senior Specialist is responsible for quality activities for the QA Warehouse program in accordance with Bristol-Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities include ensuring warehouse compliance with applicable procedures, providing real time review of warehouse records and logbooks, and working with Warehouse Operations to resolve issues. This is a Wednesday -Saturday positionworking 2nd shiftand the working hours are 4:30PM -3:00AM.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Customer Focus:

• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Contributes to goals within the work group.

Patient Focus:

• Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Able to recognize conflict and notify management with proposed recommendations for resolution.

Passion for the Role:

• Must possess an independent mindset. Work is self-directed.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Confident in making decisions for non-routine issues.
• Develops and revises procedures.
• Intermediate to advanced 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.
• Minimum 5-8 years of relevant Quality Assurance and Quality Control Incoming of Materials work experience, in the pharmaceutical, biotech, or medical device industry.
• Knowledge of GMP regulations relating to Warehousing is required.
• Knowledge of Oracle or SAP is preferred.
• Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

• Build and maintain relationships with Warehouse Operations, Supply Chain and other departments to effectively accomplish responsibilities, make improvements and resolve issues.
• Perform QA shop floor activities, focused on Warehouse Operations
• Ensure compliance with applicable procedures and warehouse requirements.
• Perform real time review of warehouse records.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, material storage and handling requirements, change control, product complaints, deviations, investigations, and CAPA management.
• Must be available for weekend and off-shift hours

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.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.