Quality Control Associate, Microbiology

About the Role

Seeking a Quality Control Associate for Microbiology to manage daily Environmental Monitoring (EM) operations in the Manufacturing facility and microbiology laboratory. This role ensures cleanrooms and classified manufacturing environments meet microbial and particulate cleanliness standards through the design, execution, and oversight of the EM Program. The position supports cGMP compliance by providing data on environmental conditions and proactively identifying contamination risks.

Key Responsibilities

• Perform Viable (Settle plates, Active Air sampling, surface monitoring, contact plates and swab sampling) and non-viable particulate monitoring as per approved SOPs.
• Perform Environmental Monitoring through LIMS software.
• Monitor different cleanroom areas including ISO5/Grade A, Grade B, C, and D.
• Perform utilities monitoring (Compressed air, Nitrogen, CO2 and O2) for viable and Non-viable particulate load.
• Perform personnel monitoring as well as gowning qualification of personnel for cleanroom work.
• Perform water sampling (Raw water, treated water, Purified water, WFI, and Pure steam) and support cross-functional departments in area qualification/requalification.
• Maintain and calibrate EM equipment (e.g., particle counters, air samplers) and related required accessories.
• Train and qualify newly joined personnel in EM program and water sampling activity.

Data Management & Trending

• Record and review EM data accurately and in a timely manner.
• Perform routine trend analysis of viable/non-viable data and report anomalies.
• Participate in alert and action level excursions and support deviation management.
• Prepare the Annual summary report for the EM program, including determination of Alert and Action levels based on historical data.

Compliance and Documentation

• Adhere to cGMP, GDP, and internal SOP requirements.
• Prepare and review EM protocols, SOPs, and investigation/study reports.
• Support regulatory and internal audits by providing EM data and justifications/rationale for EM and water sampling plans.