Senior Specialist, Quality Assurance Shop Floor, Cell Therapy; Day Shift

Position 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, 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 Senior Specialist shall serve as one of the Quality Representatives interacting with Manufacturing, Supply Chain, Quality Control and other supporting functions.

The Senior Specialist 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.

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

• Provide Quality oversight to Manufacturing/QC/Warehouse/Packout operations. Identify departures from approved procedures & respond to complex issues independently &>
• May perform and document operational verification per approved procedures.
• Develop, review and/or approve temporary and non‑routine procedures for event response.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans.
• Own actions for departmental programs and propose improvements to programs.
• Participate in Gemba walks.
• Communicate and resolve discrepancies independently and escape as required.
• Author, review, and approve procedural documents.
• Maintain compliance with assigned learning plan.
• Provide guidance and training for QA personnel.
• May own training curriculum and content.
• May present individual topics during audits as needed.
• Independently assess discrepancies for entry into quality system and approve deviations as applicable.
• May serve as quality subject matter expert for risk assessments, change controls, etc.
• Lead meetings and represent function at cross‑functional meetings.
• Share data/knowledge within and across team. Build & maintain strong relationships with partner functions.
• May prioritize and assign tasks for the team.
• Periodically observe operations on the floor and proactively identify risks and drive improvements.
• Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals.
• Function as a project manager able to influence others based on time and task commitments, organize/run meetings.
• Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, Delta
  
  V, Maximo, Infinity, etc.).
• Be familiar with GMP‑related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting.
• Share data/knowledge within and across teams by acting as a champion for quality‑culture and learning.

• Ability to research, understand, interpret and apply internal SOPs, policies and regulatory guidelines.
• Proficient computer skills with knowledge of digital tools such as MS Office and ability to learn new software applications.
• Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
• Excellent written and verbal skills and ability to present technical data effectively based on target audience.
• Ability to work in a fast‑paced team environment and lead peers through changing priorities.
• Detail oriented and task focused with ability to meet deadlines and support work prioritization.
• Negotiation and influence skills to craft mutually beneficial solutions.
• Ability to motivate and foster a positive team…