Base: $60,000pyr - $70,000pyr; bonus/equity: not s...
Cgmp-compliant testing facility
Microbiological quality control
Regulatory affairs
This role is critical in ensuring the integrity of our sterility and endotoxin testing services, supporting regulatory compliance, and facilitating the adoption of new testing methodologies
Job Summary
This role is critical in ensuring the integrity of our sterility and endotoxin testing services, supporting regulatory compliance, and facilitating the adoption of new testing methodologies.
Responsible for ensuring protocols & reports, validation qualification studies, process changes, and new services and products validation meet industry standards and regulatory requirements.
Develop, maintain, revise, and approve Standard Operating Procedures (SOPs), appendices, technical documents, and other controlled documents impacting sterility assurance, laboratory practices, and the overall Quality Management System.
Matching Summary
This role is critical in ensuring the integrity of our sterility and endotoxin testing services, supporting regulatory compliance, and facilitating the adoption of new testing methodologies.
Salary
Base: $60,000/yr - $70,000/yr; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
cGMP-compliant testing facility
microbiological quality control
regulatory affairs
sterility and endotoxin testing
documentation review and approval
deviation and CAPA management
Nice-to-have
continuous process improvement
proactive communication
highly organized
results-oriented team player
critical thinking and problem-solving
Key Requirements
Bachelor's degree in related scientific field or equivalent experience
3 years experience in cGMP-regulated environment
Regulatory knowledge for sterility and endotoxin testing
Familiarity with aseptic processing and cleanroom environments