Job Summary:

This is a challenging opportunity for a skilled Microbiologist to join our team at Insight Global as a QC Microbiologist - Cell Bank Specialist. The successful candidate will be responsible for ensuring the quality and integrity of cell banks, conducting microbiological assays, and analyzing results to ensure compliance with regulatory requirements.

Key Responsibilities:

• Cell Bank Testing: Conduct microbiological assays, including culture purity, viable count method (serial dilution), growth suitability, microbial identification, and serotype identity (agglutination) testing.
• Result Analysis and Reporting: Analyze and interpret results, making decisions regarding accuracy, completeness, and compliance.
• Documentation and Compliance: Create and maintain GMP documentation, including test results and records, validation protocols/reports, method transfer protocols/reports, and test methods.
• Process Improvement: Participate in process improvement initiatives, including SOP revisions, qualification/validation support, and leading/participating in projects.

Requirements:

• Education: Bachelor's degree in Biology or a related field.
• Experience: 5-10 years of experience in pharmaceutical manufacturing, with a focus on microbiological testing and quality control.
• Skills: Experience with LIMS, PDOCS, gQTS, eQMS, and viable count methods.