What are the responsibilities and job description for the Associate Microbiologist position at Harba Solutions Inc.?
Job Title: Microbiologist
Position Summary
The Microbiologist is responsible for performing microbiological testing and supporting quality and compliance activities for pharmaceutical and medical device products. This role contributes to product safety, regulatory adherence, and process improvements within a controlled, regulated manufacturing environment.
Key Responsibilities
- Conduct routine and specialized microbiological testing, including sterility, bioburden, endotoxin, and environmental monitoring.
- Ensure microbiological activities comply with FDA regulations, ISO standards, and internal quality system requirements.
- Support sterilization validations, cleanroom qualifications, and microbiological risk assessments.
- Maintain accurate and timely documentation of test results, investigations, and reports in accordance with GMP standards.
- Monitor aseptic practices within controlled environments and provide feedback or recommendations to improve compliance.
- Investigate microbiological deviations, perform root cause analyses, and assist with the implementation of corrective and preventive actions (CAPAs).
- Collaborate with cross-functional teams to support manufacturing, quality, and process improvement initiatives.
Qualifications
Education & Experience
- Bachelor’s or Master’s degree in Microbiology, Biology, or a related scientific discipline.
- Minimum of two (2) years of relevant microbiology experience in a pharmaceutical, biotech, or medical device environment.
Technical Skills & Knowledge
- Proficiency with microbiological testing methods and laboratory equipment such as autoclaves, incubators, and microscopes.
- Working knowledge of regulatory requirements including FDA, USP, ISO 13485, and cGMP.
- Experience working in cleanroom environments and applying aseptic techniques.
- Familiarity with sterilization processes such as ethylene oxide (EtO) and gamma irradiation is preferred.
Work Environment
- Laboratory and cleanroom-based role within a regulated manufacturing setting.
- May require adherence to gowning procedures and environmental controls.