Senior Specialist, Quality Assurance Shop Floor, Cell Therapy; Day Shift

Position:
Senior Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am–6pm)
Responsibilities

• Provide QA oversight to Manufacturing/QC/Warehouse/Packout; identify deviations from approved procedures, respond independently, and accelerate critical issues.
• Perform/document operational verification; observe operations for departures from cleanroom behaviors and aseptic techniques.
• Develop/review/approve temporary and non-routine procedures for event response.
• Coordinate/lead area walkthroughs; negotiate remediations and drive implementation alignment.
• Lead/participate in Gemba walks and cross‑functional triage meetings.
• Communicate and resolve discrepancies; author/review/approve procedural documents.
• Own quality decision‑making for unexpected floor events; triage and determine deviations.
• Review/quality‑approve GxP records (e.g., procedures, batch records, deviations); support deviation/alarm approval and other quality system records.
• Maintain learning‑plan compliance; guide/train QA personnel; support audit presentations.
• Assess discrepancies for quality system entry; approve deviations as applicable.
• Serve as SME for risk assessments/change controls; lead meetings; influence/improve programs.
• Establish KPIs/standard work databases; act as project manager for planning/meeting execution.
• Develop as SME for QA electronic systems (e.g., BMSDocs, CELabs, MES, SAP, etc.); understand GMP‑related systems (QRM, document/data governance, monitoring/reporting).

• Research/interpret/apply SOPs, policies, and regulatory guidelines.
• Strong written/verbal communication; present technical data effectively.
• Data interpretation and problem‑solving; detail‑oriented; meet deadlines.
• Computer proficiency (MS Office and new software); learn analytical/digital tools.
• Demonstrated quality management system experience (change control, complaints, deviations, investigations, CAPA).
• Demonstrated experience with GxP electronic systems (QMS, MES/electronic batch records, ERP like SAP, LIMS, electronic logbooks/forms).

• STEM bachelor’s; or HS/Associate with equivalent experience.
• 4+ years relevant cGMP experience, preferably 1+ year manufacturing site experience; FDA/EMA experience in biopharma/cell therapy.

• Health coverage; wellbeing support; 401(k); disability and life insurance; paid time off (per eligibility).