Specialist, Quality Assurance Shop Floor

Position Summary

The Quality Assurance Shop Floor team is responsible for 24x7 quality collaboration and oversight of site operations, including manufacturing, quality control laboratories, and warehouse operations. This role oversees and partners with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and global cGMP.

Day shift, Panama schedule (12‑hour shift patterns with a 2‑2‑3 work cycle including weekends and holidays). 6 AM to 6 PM.

• Provide routine quality on‑the‑floor oversight and triage unexpected events with manufacturing, quality labs, and supply chain operations.
• Interpret problems and prepare clear, concise communication for 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 the Manufacturing Execution System (MES) per approved procedures.
• Observe manufacturing operations and identify departures from procedures, cleanroom behavior, 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 for new team members.
• Independently approve deviation records within the quality management system in accordance with quality risk management principles and process knowledge.
• Review and interpret the technical conclusions of an investigation and provide constructive feedback.
• Participate in quality and shift meetings.
• Build and maintain relationships with core partner functions and seek collaborative solutions.
• Act as a champion for quality culture by sharing data and knowledge within the team.

• Action‑oriented and proficient in decision‑making, building relationships, problem‑solving, and analytical thinking.
• 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.
• Assess unfolding situations, diagnose problems, and propose practical solutions.
• Detail‑oriented, task‑focused, and able to meet deadlines and prioritize assigned work.
• Work effectively in a fast‑paced team environment with changing priorities and limited information or time constraints.
• Communicate effectively with cross‑functional peers and various levels of management through technical writing and verbal skills.
• Active listening skills to understand diverse perspectives.
• Contribute to a positive team environment.
• Make independent decisions based on data and facts, and recognize when to escalates.
• Seek opportunities for improvement in quality and operational problems.
• 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, ERP (SAP), LIMS, or electronic logbooks/forms.
• Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.

• Bachelor’s degree in a STEM field. High school diploma or associate’s degree with equivalent education and work experience is considered.
• At least 2 years of relevant cGMP experience with a minimum of 1 year of manufacturing site experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Devens, MA: $40.16 – $48.67 per hour for full‑time employees. Additional incentive cash and stock opportunities may be available based on eligibility.

• Health coverage: medical, pharmacy, dental, and vision…