Microbiologist Laboratory Reviewer

Position Summary We are a rapidly growing specialty pharmaceutical company seeking an experienced Microbiologist Laboratory Reviewer to ensure data accuracy, integrity and compliance of microbiological data within a regulated pharmaceutical manufacturing environment. Location: Sacramento Pay: $80,000 - $95,000 DOE Type: Direct Hire Key Responsibilities Review and verify microbiological laboratory data, test results, and documentation for accuracy, completeness, and compliance with SOPs, cGMP, GLP, and regulatory requirements. Evaluate microbiological method validations, method transfers, and investigation reports. Review environmental monitoring data, sterility testing results, endotoxin testing outcomes, and other microbiological analyses. Collaborate with laboratory staff and Quality teams to resolve discrepancies and investigate out-of-specification (OOS) or atypical results. Support deviation investigations, root cause analyses, and corrective and preventive action (CAPA) activities. Ensure timely review and approval of batch records and product-related documentation. Monitor laboratory trends and identify recurring issues, recommending corrective actions and process improvements as needed. Support continuous improvement initiatives related to microbiological testing, documentation practices, and data integrity. Provide guidance and training to laboratory personnel on compliance requirements and documentation best practices. Maintain accurate records of review activities and ensure proper documentation retention. Coordinate and document equipment calibration and maintenance activities. Participate in internal and external audits and provide subject matter expertise as required. Ensure all activities are performed in accordance with applicable health, safety, and environmental requirements. Manage workload effectively to meet project timelines and regulatory deadlines. Maintain confidentiality and handle sensitive information with professionalism and integrity. Stay current with industry trends, emerging technologies, and regulatory updates related to microbiology and pharmaceutical quality systems. Perform additional duties as assigned. Technical Knowledge and Skills Strong understanding of microbiological testing methodologies, laboratory operations, and data review processes. Knowledge of pharmaceutical quality systems, cGMP, GLP, and applicable regulatory requirements. Experience reviewing microbiological method development and validation activities, including: Sterility Testing Bacterial Endotoxin Testing (BET) Microbial Limits Testing (MLT) Bioassays Disinfectant Efficacy Studies Environmental Monitoring Water Testing Preservative Effectiveness Testing (PET) Microbiological Hold-Time Studies Container Closure Integrity Testing Qualifications Bachelor's degree in Microbiology, Biology, or related scientific discipline required; Master's degree preferred. Minimum of three (3) years of experience in a microbiology laboratory environment. Experience within pharmaceutical, biotechnology, sterile manufacturing, or regulated healthcare environments preferred. Knowledge of United States Pharmacopeia (USP) requirements and applicable regulatory guidelines, including FDA and cGMP requirements. Experience with microbiological method development, validation, and compendial testing, including Sterility Testing, Endotoxin Testing, Environmental Monitoring, Water Testing, Disinfectant Efficacy Studies, Microbial Limits Testing, Preservative Effectiveness Testing, Hold-Time Studies, and Container Closure Integrity Testing preferred. Benefits Competitive salary Medical, dental, and vision insurance 401(k) plan Paid time off Equal Opportunity Employer Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr