Quality Assurance Specialist III, External Manufacturing
Core
Ensuring GxP external batch records and quality records adhere to quality standards and regulatory requirements for vaccine manufacturing.
Role type
Senior IC Quality Assurance Specialist (External Manufacturing)
Builds
High-fidelity vaccines to protect against bacterial diseases
Domain
Biopharmaceuticals / Vaccine Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, regulatory guidelines (FDA/EMA/ICH), batch record review, deviation resolution, biologics manufacturing operations, root cause analysis, document control
Preferred skills
Electronic batch record review experience, technology transfer knowledge
Technologies
Electronic batch record systems
Responsibilities
Review executed batch records and product documents; Perform product disposition activities; Represent Quality Assurance in deviation and change control investigations; Participate in technology transfer and validation teams; Review and approve controlled documents; Ensure compliance with global regulatory requirements; Collaborate with manufacturing and external vendors; Drive continuous improvement in batch review processes.
Seniority
Senior, hands-on IC