Job Description
Job Description:
This role is responsible for executing microbiological testing, environmental monitoring, and method validation in a GMP-regulated laboratory. The candidate supports quality control functions, including method development, troubleshooting, and test execution for raw materials, intermediates, finished products, and stability samples. The position also ensures microbiological integrity and compliance with regulatory requirements, contributing to the successful execution of projects and audits.
Responsibilities:
- Perform QC microbiological and microbial limits testing per USP and regulatory guidelines.
- Conduct environmental monitoring, including water sampling and testing.
- Support method development, validation, and method transfer activities.
- Investigate deviations and implement CAPA; manage change controls effectively.
- Serve as subject matter expert (SME) during audits and regulatory inspections.
- Manage and support microbiology-related projects across production and formulation departments.
- Oversee testing, data reporting, and CoA preparation.
- Maintain and calibrate laboratory equipment and manage inventory of microbiology lab supplies.
- Coordinate with third-party labs for external testing as needed.
- Author and review SOPs, test protocols, and validation documents.
- Ensure safety, compliance, and proper documentation across all microbiological operations.
Requirements:
- Minimum of 3 years' experience in a regulated microbiology or QC laboratory.
- Strong understanding of USP, GMP, and regulatory compliance.
- Hands-on experience with microbiological methods, equipment validation, and lab investigations.
- Experience in managing audits and working with cross-functional teams.