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

Position: Senior Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm)
Location: Devens

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. 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:

Position:
Senior Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm) Manager:
Manager, Quality Assurance Shop Floor 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, 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 Quality 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.
• 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 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.
• 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 occurring 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…