Microbiologist Laboratory Reviewer

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Microbiologist Laboratory Reviewer (Full Time) At Nivagen as a Microbiologist Laboratory Reviewer you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements. Position Summary The Microbiology Laboratory Reviewer plays a critical role in ensuring the accuracy and compliance of microbiological data within an injectable manufacturing facility. This position is responsible for reviewing laboratory test results, protocols and reports batch records, and related documentation to verify adherence to standard operating procedures (SOPs), current Good Manufacturing Practices (cGMP) regulations, GLP, and company quality standards. The reviewer works closely with laboratory microbiologist and quality assurance teams to resolve discrepancies, support investigations, and ensure the timely release of products. Key responsibilities include evaluating microbiological method validations, transfers, and investigations, as well as assessing environmental monitoring data, sterility test outcomes, and endotoxin results. The role also involves identifying trends, supporting continuous improvement initiatives, and providing guidance on best practices in documentation and data integrity. Strong attention to detail, effective communication skills, and a commitment to maintaining high standards of safety and compliance are essential for success in this position. Duties and Responsibilities Reviews and verifies laboratory test results, ensuring compliance with SOPs, cGMP, and company policies. Evaluates method validations, transfers, and microbiological investigations for accuracy and completeness. Assesses environmental monitoring data, sterility, and endotoxin testing outcomes for quality and consistency. Collaborates with laboratory analysts and quality assurance teams to resolve discrepancies and address out-of-specification results. Supports investigations related to laboratory deviations and participates in root cause analysis. Ensures timely review and release of batch records and product documentation. Identifies trends or recurring issues in laboratory data and recommends corrective actions. Supports the implementation of process improvements and best practices in microbiological testing and documentation. Provides training and guidance to laboratory staff on data integrity and compliance requirement