Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA

Overview

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.

Specialist, QA Shop Floor Cell Therapy – Devens, MA

6am – 6pm, rotating schedule including holidays and weekends, onsite.

• 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 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 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 and 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.

• 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 batch record review, material disposition, 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 deadlines and prioritize assigned work.
• Ability to work in a fast‑paced team environment with changing priorities and limited information.
• Effectively communicate with cross‑functional peers and various levels of management through technical writing and verbal skills.
• Active listening skills to understand diverse working perspectives.
• Contributes to a positive team environment.
• Able to independently make decisions based on data and facts, and recognizes when to elevate.
• Seeks opportunities for improvement to quality and operational problems.
• Ability to work within pharmaceutical cleanroom environments.
• Experience with quality management systems for handling records such as change control, product complaints, deviations, investigations, and CAPA management.
• Experience with GxP electronic systems such as MES for electronic batch records, ERP such as SAP, laboratory information management systems, or electronic logbooks/forms.
• Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.

• Bachelor’s degree in STEM field. High school diploma or associate’s degree with equivalent combination…