QC Associate II, Microbiology

Job Description

Job Description

Description :

The Quality Associate, Microbiology is responsible for performing routine environmental and utilities monitoring of the cGMP manufacturing facilities. Conducts microbiological and chemical testing including endotoxin, bioburden, total organic carbon (TOC), and conductivity to support product release and facility compliance. Additional responsibilities include assisting with data trending, supporting method validation activities, and contributing to the drafting of protocols, reports, and SOPs related to microbiological operations. The role also involves timely and compliant reporting of test results and participation in investigations as needed.

JOB RESPONSIBILITIES

• Conduct Bioburden and endotoxin testing of in-process and products samples.
• Perform environmental monitoring (EM) of classified cleanrooms and controlled areas.
• Collect and test water samples from purified water and WFI systems.
• Maintain accurate and compliant documentation in accordance with cGMP, GDP, and internal SOPs.
• Assist in investigations of microbiological deviations and support CAPA implementation.
• Collaborate cross-functionally with Manufacturing, QA, and Validation teams.
• Perform sample management functions, such as receiving, logging, tracking, storing, and disposal of samples in accordance with SOPs and regulatory requirements.
• Other duties as assigned.

JOB REQUIREMENTS

Education and Experience

Knowledge, skills and abilities

Requirements :