Senior Specialist, Quality Assurance – Patient Material Logistics

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The Senior Specialist, Quality Assurance – Patient Material Logistics (QA-PML), is responsible for quality activities supporting Manufacturing Shared Services – Patient Material Operations (MSS-PMO) in the receipt of apheresis from domestic patient collection sites, PBMC (Peripheral Blood Mononuclear Cells) from international Make 1 facilities, and shipping cryopreserved drug product to patient infusion sites in accordance with Bristol-Myers Squibb policies, standards, procedures and Global cGMPs.

Shift Available:

• Sunday - Wednesday, Onsite Second Shift (12 p.m. - 10:30 p.m.)

Responsibilities:

• Oversee Apheresis, PBMC and CMAT receiving and Cryopreserved Drug Product (CDP) Shipping for both clinical and commercial lots of two different product lines.

• Build and maintain relationships with MSS-PMO, Warehouse, Quality, and Manufacturing Operations, as well as Supply Chain, Materials Management, Facilities and other departments to effectively accomplish tasks, make improvements, and resolve issues.

• Support or work with other departments in reviewing, approving or providing input to deviations, change controls, procedures, investigations, CAPAs and work orders.

• Ensure compliance with applicable procedures and requirements for storage, documentation, material handling, and safe equipment operation.

• Support quality processes, including material disposition, material storage and handling requirements, change controls, product complaints, deviations, investigations, and CAPA management.

• Provide QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant manner, including leading or attending triage meetings.

• Routinely recognize and resolve quality issues, inform management of proposed solutions, and seek management guidance on complex issues.

• Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

• Use electronic quality management systems (QMS) to document deviations and actions.

• Use electronic document management systems (DMS) to review, revise or approve SOPs and/or other controlled documents.

• Use ERP systems to change lot status or perform other data entry.

• Review executed records for documentation completeness and accuracy per ALCOA+.

• Review and approve patient material discards and transfers using QMS and ERP systems.

• Contribute or drive goals within the work group.

• Must be available for weekend and off-shift hours.

• Performs other assigned tasks as required to meet company or department objectives.

Knowledge & Skills:

• 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 the immediate team and with cross-functional teams to achieve objectives.

• Ability to follow technical reports or data that affects quality of materials, such as environmental/temperature tracking.

• Must have sound knowledge and experience in FDA-regulated operations and processes, as well as knowledge of US and global cGMP requirements.

• 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 b