A rapidly growing specialty pharmaceutical company is seeking an experienced Microbiologist Laboratory Reviewer. This role is responsible for ensuring the accuracy, integrity, and compliance of microbiological data within a regulated pharmaceutical manufacturing environment.
This role reviews laboratory testing results, protocols, reports, batch records, and related documentation to verify adherence to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and applicable regulatory requirements.
The successful candidate will collaborate closely with laboratory personnel and Quality Assurance teams to resolve discrepancies, support investigations, and facilitate the timely release of products. This position plays a key role in maintaining product quality, data integrity, and regulatory compliance. Position level will be commensurate with experience.
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 a 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
#IND-SPG
Estimated Min Rate: $80000.00
Estimated Max Rate: $95000.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
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.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
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. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
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.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice
