Job Description
We are seeking an experienced QC Micro Analyst to support our manufacturing operations during the qualification of new clean rooms. This is a challenging role that requires expertise in Environmental Monitoring, particularly in Grade 8/9 and Grade 5/7 Cleanrooms, as well as experience with bioburden testing, water sampling, and In Process sample testing.
The ideal candidate will have a strong background in microbiology and aseptic manufacturing, with experience working in a cGMP environment and interacting with regulatory inspectors. They will also be proficient in using LIMS and LMES software, and have excellent communication and leadership skills.
Responsibilities:
- Conduct Environmental Monitoring of Grade 8/9 Cleanrooms and Grade 5/7 Cleanrooms & Isolators
- Read and analyze Environmental Monitoring Plates
- Perform bioburden testing of water & disinfectants
- Write technical reports
- Collect and test In Process samples such as Protein Concentration, Density & pH
Requirements:
- Bachelor's degree in a science discipline
- Biopharmaceutical QC experience in a microbiology lab
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
- Strong understanding of microbiology and aseptic manufacturing principles
- Proficient in LIMS and LMES software
What We Offer:
- Opportunity to work on a high-profile project supporting manufacturing operations
- Collaborative and dynamic work environment
- Professional development opportunities
How to Apply:
Please submit your application, including your resume and cover letter, to us.