NIGHT SHIFT: Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA

Role Summary

The NIGHT SHIFT: Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA role is to provide on-the-floor quality oversight and partner with Manufacturing, Quality Control, and Warehouse Operations to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. The role supports 24x7 quality collaboration and operations across site functions, with shift coverage from 6pm to 6am on a rotating schedule including holidays and weekends.

Responsibilities

• Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
• Interpret problems and communicate clearly, concisely, and accurately to management and the group.
• Identify departures from approved procedures and respond independently while escalating complex issues to senior members.
• Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
• Observe manufacturing operations for deviations from procedures, cleanroom behaviors, and aseptic techniques.
• Provide quality oversight for pre-planned return to service plans.
• Conduct 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 learning plans and provide integration support for newer team members.
• Independently approve deviation records within the quality management system in line with quality risk management principles.
• Review technical conclusions of records/investigations and provide constructive feedback.
• Participate in quality and shift meetings; build and maintain relationships with core partner functions; share data/knowledge to champion quality culture.

Qualifications

• Required: 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience.
• Required: Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Education

• Bachelor's degree in a STEM field. High school diploma or associate's degree with equivalent combination of education and work experience is considered.

Skills

• 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 unfolding situations, diagnose problems, and propose practical solutions.
• Detail-oriented and task-focused with the ability to meet deadlines and prioritize work.
• Ability to work in a fast-paced team environment with changing priorities and limited information/time constraints.
• Effective communication with cross-functional peers and management through technical writing and verbal skills.
• Active listening to understand diverse perspectives; contributes to a positive team environment.
• Ability to work within pharmaceutical cleanroom environments and with GxP electronic systems (MES, ERP/SAP, LIMS, electronic logbooks/forms).
• Proficient with digital tools such as Microsoft Power Automate, Smartsheet, Tableau, etc.