Senior Specialist, Quality Assurance Shop Floor, Cell Therapy

Role Summary

The Senior Specialist, Quality Assurance Shop Floor, Cell Therapy is responsible for 24x7 quality collaboration and oversight of site operations across Manufacturing, Quality Control, and Warehouse operations. The role monitors process performance, owns and approves floor quality GxP records, and supports deviations and other quality system activities. This is an individual contributor role with a Monday–Friday day shift.

Responsibilities

• Provide quality oversight to Manufacturing, QC, Warehouse, and Packout operations; identify departures from approved procedures and escalate critical issues to management.
• May perform and document operational verification per approved procedures.
• Develop, review, and/or approve temporary and non-routine procedures for event response.
• Observe manufacturing operations for clean room and aseptic technique adherence.
• Coordinate and lead area walkthroughs to identify quality issues; negotiate remediation and implement alignment plans.
• Own actions for departmental programs and propose improvements.
• Participate in Gemba walks.
• Communicate and resolve discrepancies; escalate as required.
• Author, review, and approve procedural documents.
• Maintain compliance with learning plans; provide guidance and training for QA personnel; may own training curriculum/content.
• May present topics during audits as needed.
• Independently assess discrepancies for entry into quality system and approve deviations as applicable.
• May serve as QA SME for risk assessments, change controls, etc.
• Lead meetings and represent function in cross-functional meetings; share data/knowledge; build relationships with partner functions.
• Prioritize and assign tasks for the team; observe operations to identify risks and drive improvements.
• Establish and maintain KPIs and standard work databases aligned with goals.
• Act as a project manager to influence others, organize and run meetings.
• Obtain access to and develop as an SME for shop floor quality systems (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.).
• Familiarity with GMP-related systems including Quality Risk Management, Document/Data Governance, Monitoring and Reporting.
• Champion quality culture and learning across teams.

Qualifications

• Demonstrated experience with quality management systems for records such as change control, product complaints, deviations, investigations, and CAPA management.
• Ability to interpret and apply internal SOPs, policies, and regulatory guidelines.
• Proficient computer skills with MS Office and ability to learn new software.
• Ability to interpret data, analyze complex problems, and articulate practical solutions.
• Excellent written and verbal communication; ability to present technical data to varying audiences.
• Ability to work in a fast-paced team environment and lead through changing priorities.
• Detail-oriented, task-focused, with ability to meet deadlines and prioritize work.
• Negotiation and influence skills to craft mutually beneficial solutions; ability to motivate teams.
• Strong decision-making and creative thinking while maintaining compliance and quality.
• Experience with analytical digital tools (e.g., Microsoft Power Automate, Smartsheet, Tableau).

Education

• Bachelor's degree in a STEM field preferred. High school diploma or Associate degree with equivalent experience may be considered.
• 4+ years of relevant cGMP experience; manufacturing site experience preferred. FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is a plus.
• Experience with quality management systems; familiarity with QMS, MES, SAP or other electronic systems.