Quality Assurance Technician
Core
Quality Assurance Technician supporting sterile biologics manufacturing by ensuring GMP compliance, process adherence, and documentation integrity on the production floor.
Role type
Operational Quality Assurance Technician (Biologics)
Builds
Sterile biologics and protein-based pharmaceutical products
Domain
Pharmaceutical manufacturing (Biologics)
Required skills
Sterile pharmaceutical manufacturing experience, GMP knowledge, aseptic process understanding, batch documentation management, deviation handling, root cause analysis, shift work adaptability
Preferred skills
QA/QC/Microbiology background, coaching/mentoring ability, continuous improvement mindset, cross-functional collaboration
Technologies
GMP systems, batch documentation tools, production monitoring equipment
Responsibilities
Perform quality oversight in production to ensure adherence to processes and quality standards; Coach operators and team leads on quality-related issues; Review and validate batch documentation and protocols for completeness and GMP compliance; Identify, communicate, and follow up on quality risks, deviations, and improvement opportunities; Collaborate with production and other functions to implement sustainable solutions; Escalate quality-related issues as needed.
Seniority
Mid-level, hands-on IC