QC Analyst II *PC 610

Position Overview

This position is primarily responsible for the complete development, qualification and performance of environmental monitoring and microbiological QC assays to support GMP manufacturing operations in a Phase I/II multi-product biologics facility. Responsibilities include development, qualification and execution of environmental monitoring processes and microbiological assays, development and review of trend reports, SOPs, batch related EM results, and other controlled documents.

Essential Duties and Responsibilities

• Develop and execute environmental monitoring in ISO5/7/8 clean rooms
• Develop and execute microbiological assays, such as sterility.
• Adhere to all applicable SOPs for clean rooms, quality control and quality assurance
• Develop GMP documentation such as trend reports, SOPs and documents to support equipment operation.
• Responsible for the proper maintenance and use of equipment in ...