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Microbiologist

External
Full-timeOn-site1mo ago
AccessibilityComplianceDocumentation
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About the role

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 Title of the Position: Microbiologist (Full Time) At Nivagen as a Microbiologist 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 As a Microbiologist you will play a critical role in the success of our operations. This position is integral to our commitment to excellence, as it involves developing and validating microbiological test methods, maintaining detailed records, and preparing reports, protocols, and standard operating procedures (SOPs). Your expertise will directly contribute to Quality and affordable medication. Collaboration is key in this role. You will work closely with cross-functional teams to meet project objectives and timelines and identify opportunities for process improvements. Your proactive approach and innovative mindset will help us enhance efficiency and effectiveness within our microbiology laboratory and reinforce our dedication to quality and compliance. Additionally, in this influential role you will be a mentor, providing training and guidance to microbiology staff, fostering an environment of continuous learning and professional growth. Joining Nivagen as a Microbiologist means being part of a visionary team dedicated to expanding access to quality, affordable medication. If you are passionate about quality, service, and innovation, and are eager to make a difference in people's lives, we invite you to bring your expertise and enthusiasm to our dynamic team. Duties and Responsibilities Conducts microbiological testing of primary packaging materials, raw materials, in process sample, finished products, and environmental samples using various techniques, including microbial enumeration, identification, and antimicrobial effectiveness testing. Develops and validates microbiological test methods in accordance with compendial and regulatory requirements. Maintains accurate and detailed records of all microbiological testing and analysis performed. Prepares and reviews reports, protocols, and SOPs related to microbiological activities. Ensures compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies and procedures. Participate in internal and external audits as needed. Microbiology-related projects, including method transfers, validations, and investigations. Collaborates with cross-functional teams to achieve project objectives and timelines. Provides training and mentorship to microbiology staff. Shares knowledge and expertise to promote continuous learning and development within the microbiology team. Identifies opportunities for process improvements and optimization within the microbiology laboratory. Implements best practices and innovative solutions to enhance efficiency and effectiveness. Performs a variety of Microbiology testing to assess the strength, identity, and purity of test samples and/or materials. Performs other duties as assigned. While performing the responsibilities of the job, the employee is required to talk and hear. Must be able to bend at the waist and knees as well as twist at the trunk. Must be able to lift up to 25 lbs. Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. Personal protective equipment and Respir

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