Quality Control Microbiologist
Summary
Performs microbiological and analytical testing on raw materials, intermediates, and finished products using HPLC, UV-Vis, and other lab instruments to ensure compliance with GMP/GLP standards.
Position Summary:
As a QC Microbiologist, you will be mainly responsible for conducting microbiological analyses for raw materials, intermediates, and finished product samples according to written procedures. This is a more experienced position requiring sound knowledge of quality control systems, methods, and procedures.
Position Responsibilities:
• Accountable for microbiological testing of raw materials, intermediates, and/or finished product samples as required by the procedure so that manufacturing activities are not impacted.
• Support routine Environmental Monitoring activities including room monitoring, utility monitoring, and allergen/protein testing.
• Owns the OOS process that pertains to microbiological testing and analysis.
• Reviews data and results of testing to ensure compliance to appropriate specifications.
• Assisting investigating non-conforming products and disposition.
• Assist with investigations and pertinent customer complaints and submit findings to QC/QA manager.
• Orders supplies and assigns expiry to incoming materials, tracks requisitions and reconciles against incoming materials.
• Writes and executes protocols for the qualification and re-qualification of new and current instrumentation as applicable.
• Troubleshoots instrumentation/test methods.
• Follows technology changes, recommends new technologies, purchase and implement if appropriate.
• Staying abreast of regulatory changes related to the industry.
• May serve as a technical resource relating to Microbiology within the department as well as cross functionally.
• Assisting as needed in all other aspects of the QC department.
• Other duties as assigned by the QC manager.