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 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.

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 Respirators are essential for the health and safety of employees. Position requires working in the laboratory as well as sitting Microbiological method development and method validation procedures like 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: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• 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, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of 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: United States Pharmacopeia, and regulatory requirements (Food and Drug Administration and cGMP) preferred.
• Experience with microbiological method development and method validation procedures like Sterility Testing, Endotoxin Testing, Disinfectant Efficacy Study, 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
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
• Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan

Additional Information:

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

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.