Quality Associate III, Sterility Assurance
Core
Support QC Sterility Assurance operations for sterile pharmaceutical manufacturing by executing studies, investigations, and risk assessments to ensure patient safety and process integrity.
Role type
Senior IC Quality Associate (Sterility Assurance)
Builds
Sterile pharmaceutical products
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
aseptic processing, contamination control, sterilization/decontamination, environmental monitoring, microbiological control, GMP compliance, data analysis, risk assessment, technical writing, problem-solving
Preferred skills
sterile process qualification, biological indicator studies, cycle development, CAPA implementation
Technologies
GMP, biological indicators, chemical indicators, environmental monitoring systems
Responsibilities
Plan and execute sterility assurance studies and qualification activities; Analyze environmental and microbiological data to identify trends; Lead or support investigations and risk assessments; Develop and execute corrective and preventive actions (CAPA); Prepare GMP documentation and technical reports; Collaborate cross-functionally with Manufacturing, Microbiology, and Validation teams.
Seniority
Mid-level, hands-on IC