Job Description:
As a Microbiologist Analyst in the Quality Control department of pharmaceutical manufacturing, you will play a crucial role in ensuring the safety, quality, and compliance of pharmaceutical products. Your primary responsibility will involve performing microbiological testing on raw materials, in-process samples, finished products, and environmental samples to assess microbial contamination and compliance with regulatory standards.
Key Responsibilities:
Conduct microbiological analysis on various samples including raw materials, finished products, water, and environmental monitoring samples using techniques such as microbial enumeration, microbial identification, endotoxin testing, sterility testing, and microbial limits testing.
Perform environmental monitoring of manufacturing areas to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
Maintain and calibrate laboratory equipment used for microbiological testing.
Prepare and maintain accurate documentation of all testing procedures, results, and laboratory investigations in accordance with regulatory guidelines.
Participate in method validation and method transfer activities for microbiological test methods.
Investigate and troubleshoot any deviations or out-of-specification results, and propose corrective and preventive actions (CAPAs) as necessary.
Collaborate with other departments such as Manufacturing, Quality Assurance, and Regulatory Affairs to ensure timely release of products and resolution of quality issues.
Stay updated on current industry trends, regulatory requirements, and best practices in microbiological testing and quality control.
Contribute to continuous improvement initiatives aimed at enhancing the efficiency and effectiveness of quality control processes.
Qualifications:
Bachelors degree or higher in Microbiology, Biology, or related field.