QA Operations Specialist
Core
Provide direct quality support and oversight to manufacturing operations for vaccine production, ensuring compliance with GMP and documentation practices on the shop floor.
Role type
Quality Operations Specialist (Manufacturing)
Builds
Vaccine drug products and drug substances
Domain
Biopharmaceuticals / Vaccines
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, documentation review, batch record approval, SOP management, deviation investigation, change control, audit readiness, data integrity, problem-solving
Preferred skills
QMS implementation, bioprocessing knowledge, aseptic manufacturing, technical transfer, analytical aptitude, leadership
Technologies
Electronic Batch Records (EBR), Quality Management Systems (QMS)
Responsibilities
Review and approve Master Batch Records, Electronic Batch Records, and production documentation; Maintain active shop floor presence for compliance; Participate in site Tier process for quality resolution; Support Commissioning and Qualification lifecycle documents; Serve as SME for Performance Qualification activities; Support internal audits and external regulatory inspections; Drive continuous improvement initiatives.
Seniority
Mid-level, hands-on IC
