Microbiologist

Leiters Inc•Englewood, CO

About The Position

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. This role offers a dynamic opportunity to drive environmental monitoring and Quality processes in a collaborative team setting.

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

Responsibilities

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