Specialist, Shop Floor Quality Assurance, Night Shift

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.

This role works on a rotating night shift schedule from 6pm-6am.

Position Summary:

The Specialist, Shop Floor Quality Assurance is responsible for supporting shop-floor activities in manufacturing operations at Devens in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs).  Functional responsibilities include triaging and supporting the resolution of unexpected events in conjunction with area owners; proactively monitoring process performance and identifying departures from accepted standards; conduct routine reviews and approvals of GxP documents including, but not limited to electronic batch record review, and logbooks; executing operational tasks in the electronic batch records such as, but not limited, to disposition of incoming apheresis patient material.

The Shop Floor Quality Assurance Manufacturing team is primarily responsible for oversight of production and adjacent activities which support the creation of autologous Cell Therapy drug products. Individuals of this team are expected to have a presence on-the-floor during which they apply knowledge of cGMP, BMS policies, and regulatory requirements to ensure patient safety. Team members are expected to partner routinely with counterparts in manufacturing to assess and continuously improve the general state of the facility and operations. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed as we are often the first members of the Quality Unit to be contacted for routine and non-routine activities supporting operations.

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 & 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

Education & Experience:

• Bachelor