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

Role Summary

The Specialist, Quality Assurance Shop Floor Cell Therapy oversees and partners with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. The role supports 24x7 quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations. Location: Devens, MA. Shifts Available: 6am – 6pm, rotating scheduling including holidays and weekends, onsite.

Responsibilities

• Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
• Interpret problems and prepare communication to management and 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. 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.

Qualifications

• Required: Bachelor's degree in a STEM field. High school diploma or associate's degree with equivalent education/experience considered.
• 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.
• Required: Experience with quality processes including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Required: Ability to assess unfolding situations, diagnose problems, and propose practical solutions; detail-oriented and able to meet deadlines; ability to work in a fast-paced team with changing priorities.

Skills

• Action-oriented, proficient in decision-making, relationship-building, problem-solving, and analytical thinking.
• Ability to understand, follow, and apply internal policies, procedures, and quality principles.
• Strong written and verbal communication; effective with cross-functional peers and management; active listening.
• Independent decision-making with appropriate escalation when needed; opportunities for continuous improvement.
• Ability to work within pharmaceutical cleanroom environments; experience with quality management systems (change control, deviations, investigations, CAPA).
• Experience with GxP electronic systems (MES, SAP/ERP, LIMS, electronic logbooks/forms) and proficiency with digital tools (Power Automate, Smartsheet, Tableau, etc.).

Education

• Bachelor's degree in a STEM field. Alternative combinations of education and work experience may be considered.