Microbiologist Laboratory Reviewer

Overview 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 microbiologists 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 requirements. Maintains thorough records of all review activities and ensures proper documentation is in place. Calibration and maintenance coordination and record. Participates in internal and external audits as required, providing relevant documentation and expertise. Ensures all work is conducted in accordance with health, safety, and environmental regulations. Demonstrates strong organizational skills and manages workload to meet project timelines and regulatory deadlines. Maintains confidentiality and handles sensitive information with professionalism and integrity. Continuously updates knowledge of relevant regulations, industry trends, and technological advancements in microbiology. Performs other duties as assigned. During work, the employee may talk and hear. Must be able to bend at the waist and knees, twist at the trunk, and lift up to 25 lbs. Must wear laboratory protective gowning and equipment, including gowning, goggles, face shields, respirators, and protective gloves. Personal protective equipment and respirators are essential for health and safety. Position requires working in the laboratory as well as performing microbiological method development and method validation procedures such as BET, Sterility, MLT, Bio Assay and Disinfectant qualification and microbiological hold time validation, container closure integrity validation. Knowledge and Skills Strong knowledge of microbiological testing techniques, reviewing methods, and equipment. Key Competencies Customer Focus: Ability to build strong customer relationships and deliver customer-centric solutions. Optimizes Work Processes: Focus on continuous improvement and efficient processes. Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives. Resourcefulness: Secures and deploys resources effectively and efficiently. Manages Complexity: Makes sense of complex information to solve problems. Ensures Accountability: Holds self and others accountable to meet commitments and objectives. Situational Adaptability: Adapts approach to shifting demands of different situations. Communicates Effectively: Delivers clear multi-mode communications for different audiences. Experience and Qualifications Bachelor's degree in microbiology, biology, or related field required; Master's degree preferred. Minimum of 3 years of experience in a microbiology laboratory required. Previous experience in a pharmaceutical or compounding environment preferred. Experience with compendia testing (USP) and regulatory requirements (FDA and cGMP) preferred. Experience with microbiological method development and method validation procedures such as Sterility Testing, Endotoxin Testing, Disinfectant Efficacy Studies, Water Testing, Method Validation, Environment Monitoring, Microbial Limit Testing, PET, and microbiological hold time validation, container closure integrity. Benefits Pay range $75,000-$85,000 per year Yearly bonus eligibility Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information Nivagen is an equal opportunity employer and prohibits discrimination and harassment of any kind. We are focused on building a diverse and inclusive workforce. If you’re excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply. #J-18808-Ljbffr Nivagen Pharmaceuticals, Inc.