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

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

Specialist, Quality Assurance Shop Floor, Cell Therapy – Devens, MA – Bristol Myers Squibb – Devens, MA – Full‑time – Associate – Quality Assurance – Pharmaceutical Manufacturing.

6am – 6pm, rotating scheduling 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. 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 with limited information and/or time-constraints.
• 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 of records such as change control, product complaints, deviations, investigations, and CAPA management.
• Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records;
  Enterprise Resource Planning (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 of education and work experience is considered.
• 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Devens, MA – US: $83,540 – $101,228.

The starting compensation range(s) for…