Senior Specialist, QA Shop Floor, Cell Therapy in Devens, MA

Overview

Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers work that transforms lives of patients and careers of team members. You will have opportunities to grow and thrive alongside high-achieving teams in a role within Cell Therapy’s Quality Assurance Shop Floor.

The Quality Assurance Shop Floor team provides 24x7 quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations. The Senior Specialist, Quality Assurance Shop Floor, Cell Therapy, will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and global cGMP.

In this capacity, the Senior Specialist shall serve as a Quality Representative interacting with Manufacturing, Supply Chain, Quality Control and other supporting functions. The Senior Specialist, QA Shop Floor, is accountable to own quality decisions related to unexpected events on the production floor, deviation triage, and determination. They will participate in cross-functional triage meetings and own, review or quality approve GxP records including procedures, batch records, or deviations.

The incumbent shall support deviation approval, alarm approval, and other Quality System Records as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for team success.

Shifts Available A1 & B1 - 6am - 6pm, rotational schedule including holidays and weekends.

• Provide Quality oversight to Manufacturing/QC/Warehouse/Packout operations. Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management.
• May perform and document operational verification per approved procedures.
• Develops, reviews and/ or approves temporary and non routine procedure for event response.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans.
• Own actions for departmental programs and propose improvements to programs.
• Communicate and resolve discrepancies independently and escalate as required.
• Author, review, and approve procedural documents.
• Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel.
• May own training curriculum and content.
• Independently assess discrepancies for entry into quality system and approve records as applicable.
• Lead meetings and represent function at cross functional meetings.
• Share data/knowledge within and across team. Build & maintain strong relationships with partner functions.
• May prioritize and assign tasks for the team.
• Observe operations on the floor and proactively identify risks and drive improvements.
• Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals.
• Able to influence others based on time and task commitments, organize/run meetings.
• Obtain access to, and develop as an SME for, various electronic systems used by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, Delta
  
  V, Maximo, Infinity, etc.).
• Should be familiar with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting.

• Ability to research, understand, interpret and apply internal SOPs, policies and regulatory guidelines.
• Proficient computer skills with MS Office and ability to learn new software applications.
• Ability to interpret data and results, understand complex problems with multiple variables, and articulate practical solutions.
• Excellent written and verbal skills and ability to present technical data effectively to target audiences.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Detail-oriented and task-focused with ability to meet deadlines and support work prioritization.
• Ability to negotiate and influence to craft mutually beneficial solutions.
• Ability to motivate and foster a positive team environment.
• Strong decision-making ability and creativity while maintaining compliance and quality.
• Experience with quality management systems for handling records such as change control, product complaints, deviations, investigations, and CAPA management.
• Experience with analytical digital tools (e.g., Power Automate, Smartsheet, Tableau).
• Experience with quality management systems and GxP electronic systems such as QMS, MES (electronic batch records), ERP (SAP), LIMS or electronic logbooks/forms.

• Bachelor s degree in STEM field preferred. High school diploma/Associates degree with equivalent education and work experience may be considered.
• 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy…