Quality Control Specialist
4 hours ago
QC Environmental Monitoring Specialist
Our client, a cell and gene therapy company, is seeking a Quality Control Specialist to support aseptic manufacturing and ensure product quality. The ideal candidate will have experience in biologics/pharmaceuticals, particularly in aseptic processing and mammalian cell culture.
Responsibilities:
Conduct environmental monitoring in clean rooms (air, surface, personnel, particulate)
Verify batch records for critical aseptic manufacturing steps
Perform Growth Promotion testing on prepared media
Direct Sterile Media Fill Trials and conduct support testing
Maintain QC laboratory housekeeping
Assist in daily QC operations
Author/revise QC SOPs to ensure compliance
Respond promptly to Out of Specification (OOS) results and notify supervisors
Coordinate with Operations (Manufacturing, QA, Facilities) to meet objectives
Use analytical equipment to support product quality
Train employees as needed
Complete thorough Manufacturing Investigation Reports (MIRs) to identify root causes, assess impact, and implement corrective actions
Requirements:
Bachelor of Science in a scientific discipline
Knowledge of cGMP and industry standards
Experience in biologics/pharmaceuticals, especially in aseptic processing and mammalian cell culture
Familiarity with basic lab equipment (microscopes, pH meters, incubators)
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