Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm Rotating Shift Schedule)

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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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Position: Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm - Rotating 2-3-2 Panama Schedule)

Manager: Manager, Quality Assurance Shop Floor

Position Summary

Note: This position works a rotating 2-3-2 Panama schedule (6am to 6pm ), Day shift.

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 Warehouse Operations.
This position will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
In the capacity of QA Shop Floor, the Specialist shall serve as one of the Quality Representatives interacting with Manufacturing, Supply Chain, Quality Control and other supporting functions.
The Specialist, QA Shop Floor, is accountable to own quality decision making as it relates to unexpected events on the production floor, deviation triage and determination. Participation in cross-functional triage meetings. They own; review or quality approve GxP records including but not limited to procedures, batch records, or deviations. Additionally, the incumbent shall support deviation approval, alarm approval, and other Quality System Records as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed.

This position reports to the Shift Manager, Quality Assurance Shop Floor.
This position works a rotating 2-3-2 Panama schedule (6am to 6pm ), Day shift.

Key Responsibilities

• Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
• Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
• Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members.
• Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
• Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques.
• Provide quality oversight for pre-planned return to service plans.
• Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners.
• Identify and propose improvements to programs, procedures, and practices.
• Review manufacturing batch records or QC testing records to ensure compliance with approved procedures.
• Review and provide feedback on documents such as forms, logbooks, and procedures.
• Maintain compliance with assigned learning plan. Provide integration support of newer team members.
• Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
• Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
• Participate in quality and shift meetings.
• Build and maintain relationships with core partner functions and seek collaborative solutions.
• Share data/knowledge within team by acting as a champion for quality-culture.
• Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.).

Qualifications & Experience

• Must be action-oriented and proficient in decision-