Microbiologist
Leiters Inc
Summary
This position reports directly to the Quality Aseptic Manager. The role is responsible for overseeing third party sterility testing and environmental monitoring testing for the Company's 503B sterile cGMP manufacturing facility. Responsible for environmental monitoring program including sampling, scheduling, and trending activities.
Job description
Essential Functions
- Oversee environmental monitoring (EM) program, assist as needed
- Oversee EM process qualifications of new cleanroom areas
- Oversee microorganism identification program
- Understand Leiter's monitoring programs and methods and conduct troubleshooting analysis
- Oversee or perform growth promotion testing of media as per compendial methods
- Assist in internal laboratory, as needed
- Work with internal and external resources to maintain lab in an optimal state
- Monitor, trend, and report environmental monitoring data, keeping management informed on trends and implementing corrective actions as necessary
- Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release
- Assist in generation of CoAs for product release as needed
- Develop, revise, and review SOPs, job aids, forms, qualification/validation protocols, and reports
- Assist in investigations regarding out of specifications (OOS) results and deviations through root cause analysis
- Manage CAPAs and change controls to ensure timely resolution of issues and continuous improvement of Quality processes
- Monitor the GMP systems currently in place to ensure compliance with documented policies
- Review and assess proposed changes to procedures, systems, methods, and regulatory submissions as appropriate
- Gather and analyze metrics to drive continuous improvement in areas of responsibility
- Collaborate with Training, Quality Aseptic, and other departments for implementing process improvements and job aids
- Collaborate with Quality Control department to ensure timely completion of environmental monitoring testing and sterility testing as needed for batch release
- Perform other duties as required
Experience and Necessary Skills
- Bachelor's degree in Microbiology, Biology, or related technological field of science required
- 1-3 years of microbiology lab experience and/or environmental monitoring in the biotech and/or pharmaceutical industry working with sterile injectables required
- Proficient in microbiological techniques, including air monitoring, water testing, surface monitoring, and microbial identification
- Experience with aseptic technique and cleanroom operation
- Experience with the sterile gowning procedures
- Knowledge of regulatory requirements for aseptic operations and manufacturing of sterile drug products
- Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211)
- Strong knowledge of GMP, SOPs, and quality control processes
- Experience managing and resolving OOS results and investigations
- Working knowledge of aseptic manufacturing and EM processes
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel
- Strong critical thinking, troubleshooting, and problem-solving abilities
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Excellent interpersonal, verbal, and written communication skills in a collaborative work environment
- Comfortable in a fast-paced, small company environment with minimal oversight and able to adjust workload based upon changing priorities
Requirements
- Bachelor's degree in Microbiology, Biology, or related technological field of science required
- 1-3 years of microbiology lab experience and/or environmental monitoring in the biotech and/or pharmaceutical industry working with sterile injectables required
- Proficient in microbiological techniques, including air monitoring, water testing, surface monitoring, and microbial identification
- Experience with aseptic technique and cleanroom operation
- Experience with the sterile gowning procedures
- Knowledge of regulatory requirements for aseptic operations and manufacturing of sterile drug products
- Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211)
- Strong knowledge of GMP, SOPs, and quality control processes
- Experience managing and resolving OOS results and investigations
- Working knowledge of aseptic manufacturing and EM processes
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel
- Strong critical thinking, troubleshooting, and problem-solving abilities
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Excellent interpersonal, verbal, and written communication skills in a collaborative work environment
- Comfortable in a fast-paced, small company environment with minimal oversight and able to adjust workload based upon changing priorities
Benefits
- Healthcare coverage
- FSA & HSA
- Dental & Vision insurance
- Employer Paid Life Insurance
- Employee Assistance Program
- Short & Long-Term Disability
- 401(k) Matching
- Paid Time Off
- Tuition Reimbursement
- Referral Bonus Program
- Annual Bonus Program
Company overview
Leiters Health, operating as Leiters Inc, is a leading FDA-registered 503B outsourcing provider specializing in high-quality compounded sterile preparations and pharmacy services. Founded in 1926 and headquartered in Englewood, Colorado, the company has evolved from a small family pharmacy into a sophisticated pharmaceutical manufacturing organization serving hospitals, surgery centers, clinics, and physician offices nationwide. Leiters operates state-of-the-art facilities that produce ready-to-administer compounded medications, including pre-filled IV bags, syringes, and concentrated vials for critical care, ophthalmology, anesthesia, and pain management applications. The company's expertise spans sterile pharmaceutical manufacturing, repackaging, and compounding, with a strong focus on quality, consistency, and regulatory compliance under Current Good Manufacturing Practices (cGMP). Leiters plays a vital role in addressing drug shortages and supporting healthcare providers with reliable, high-quality pharmaceutical solutions that enhance patient safety and streamline clinical workflows.