• Quality Control & Analysis: Conduct and oversee microbiological testing, including bioburden, sterility, endotoxin, and environmental monitoring for raw materials and finished products.
• Regulatory Compliance: Ensure all laboratory operations and documentation strictly adhere to established SOPs and industry regulations (e.g., GLP, cGMP, ISO standards) for audit readiness.
• Investigation & Corrective Actions: Lead root-cause investigations for out-of-specification (OOS) results or microbial contamination incidents, implementing corrective and preventive actions (CAPA).
• Laboratory Management: Supervise daily lab operations, oversee the calibration of analytical equipment, manage media and reagent inventory, and enforce strict biosafety protocols.