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

Role Summary

Senior Specialist, Quality Assurance Shop Floor, Cell Therapy (Devens, MA) oversees quality assurance on the production floor to ensure GxP compliance across Manufacturing, Quality Control laboratories, and Warehouse Operations. They serve as a Quality Representative interfacing with Manufacturing, Supply Chain, Quality Control and other supporting functions, owning quality decisions related to deviations and unexpected events on the shop floor. They review or approve GxP records and support Quality System Records as requested by management.

Responsibilities

• Provide Quality oversight to Manufacturing/QC/Warehouse/Packout operations. Identify departures from approved procedures and respond to complex issues independently, escalating critical issues to management.
• May perform and document operational verification per approved procedures.
• Develops, reviews and/or approves temporary and non-routine procedures 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 the quality system and approve records as applicable.
• Lead meetings and represent the function at cross-functional meetings.
• Share data/knowledge within and across teams. Build and 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 and run meetings.
• Obtain access to, and develop as an SME for, electronic systems used by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.).
• Should be familiar with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting.

Qualifications

• Bachelor's degree in a STEM field preferred. High school diploma/Associate degree with equivalent combination of 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 manufacturing is preferred.
• Demonstrated experience with quality management systems for handling records such as change control, product complaints, deviations, investigations, and CAPA management.

Skills

• Ability to research, understand, interpret and apply internal SOPs, policies and regulatory guidelines.
• Proficient computer skills with knowledge of digital tools (MS Office, etc.) and ability to learn and work with 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 different 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 the capacity to think creatively while maintaining compliance and quality.
• Demonstrated experience with quality management systems for handling records such as change control, deviations, investigations, and CAPA management; familiarity with analytical tools (Power Automate, Smartsheet, Tableau, etc.).
• Experience with quality management systems and GxP electronic systems (QMS, MES, SAP, LIMS or electronic logbooks/forms).

Education

• Bachelor's degree in a STEM field preferred.
• High school diploma or Associate degree with equivalent combination of education and work experience may be considered.

Additional Requirements

• On-site work is required; site-essential roles require 100% onsite shifts. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite. For field-based or remote-by-design roles, travel to visit customers, patients or business partners and to attend meetings on behalf of the company is an essential job function.