Senior Specialist, Shop Floor Quality Assurance

Working with Us
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 rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Position Summary

The Shop Floor Quality organization has responsibility for quality oversight and responsibility for advising and assuring quality operations at the Devens Cell Therapy Facility in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs).

In the capacity of Shop Floor QA, the Senior Specialist shall serve as one of the Shop Floor Representatives interacting with Quality Control and Laboratories, additionally the individual will be tasked and responsible to handle Shop Floor Quality internal compliance, training and documentation tasks, routine communication to front line employees, and metrics/monitoring for key processes. The incumbent will have responsibility to implement both GMP and business systems/processes with the guidance of the Shop Floor Leadership team, with the goal of enabling the highest standards of patient safety, compliance, and operational efficiencies.

The Senior Specialist, Shop Floor QA, is accountable to monitor and track process performance related to key Shop Floor quality assurance quality tasks and other operational tasks through data and analytics; to own, review or approve Floor Quality GxP records including but not limited to procedures, CAPAs, change controls, impact assessments, documentation, or deviations; and represents SFQA at relevant governance forums. Additionally, the incumbent shall flex to support deviation approval or batch record review 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 Associate Director, Shop Floor Quality Assurance, and is a key member of the Shop Floor Quality leadership team. This is an individual contributor role working Monday to Friday.

Key Responsibilities

• Work in consult with FQA Senior Managers and Managers to proactively identify and implement Quality Management System (QMS), procedures or other communications to improve quality operations.

• Must have the ability to evaluate complex situations/data and make recommendations within the FQA leadership team and cross-functionally. 

• Provide Quality on-the-floor oversight to [Manufacturing/QC/Warehouse/ Packout] operations. Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management.

• May perform and document operational verification per approved procedures.

• Develops, reviews and/ or approves temporary and non routine procedure for event response.

• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.

• Provide quality oversight to non routine maintenance  work. Review and approve return to service plans.

• Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediation's and drive alignment of implementation plans.

• Own shift actions for departmental programs and propose improvements to programs.

• Participate in Gemba walks.

• Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies independently and escalate 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.

• <