- Support the onboarding/qualification of new Microbiology lab
- Environmental monitoring of cGMP controlled areas.
- Total particulate count monitoring of controlled areas.
- Sampling and testing of pharmaceutical grade water.
- Microbial identifications, Growth promotion, Bioburden, Endotoxin, Biological Indicator, and Sterility testing.
- Support the onboarding/qualification of new Micro laboratory equipment
- Proficiently perform all qualified testing methods used by the Microbiology department.
- Perform all other duties assigned
- Bachelor’s degree in microbiology, biology, or other relevant scientific discipline and 5-10 years of related laboratory experience; or equivalent combination of education and experience.
- Must possess proven understanding of SOPs and cGMP guidelines and regulations. Familiarity with USP <61> and <62> and micro suitability requirements.
- Must possess excellent communication (oral and written), organizational, and interpersonal skills.
- Detail oriented with strong aseptic techniques and documentation skills.
- Ability to follow SOPs and cGMP guidelines and regulations is required.
- Must be able to work in a team environment and perform job responsibilities under minimal supervision.