Specialist QA Shop Floor

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.

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, Label Operations and Warehouse Operations.  This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.  Shifts: Multiple Shifts Open Sun-Wed Days Wed-Sat Days Sun-Wed Nights Wed-Sat Nights Duties / Responsibilities Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, Label Operations 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 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.  For markets requiring an Authorized Person (AP) release to be performed by Summit, act as designated AP performing Certification/Release for Supply in accordance with the PIC/S Guide to GMP (including Annex 16) and any local market requirements e.g. Australian Therapeutic Goods Administration (TGA) requirements, including the Therapeutic Goods Act 1989 and associated GMP principles. Perform verification and reconciliation of issued drug product labels. Reporting Relationship Reports to the Manager, Quality Assurance Shop Floor Qualifications Specific Knowledge, Skills, Abilities: Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking.   Ability to understand, follow, and apply internal policies, procedures, and quality principles.   Prior experience with quality processes, including but not limited to batch record review, change control, product complaints, deviations, investigations, and CAPA management.  Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions.   Detail-oriented and task-focused with the ability to meet