We are currently seeking a Microbiology Lab Technician who will be responsible for performing routine and non-routine microbiological testing according to established procedures or approved protocols. The Microbiology Lab Technician will also provide support to the operations and manufacturing departments to ensure safe and effective finished product release.
- Responsible for performing routine and non-routine microbiological testing according to established procedures or approved protocols.
- Perform microbiological testing on raw materials, finished products, in process samples, and stability samples.
- Experience with common microbiology lab instrumentation is a requirement, especially with autoclaves, Incubators, air samplers, light microscope, bio safety cabinet.
- Working knowledge and practical experience with good manufacturing practices in a microbiology lab environment.
- Perform microbiology testing programs such as Microbial limits testing, Antimicrobial effectiveness testing, Purified water testing, Antibiotic assay in compliance with USP, FDA requirements.
- Perform Environmental monitoring of controlled areas, growth promotion on media used in microbiology lab, also perform gram staining.
- Maintain laboratory records in compliance with Good Laboratory Practice standards.
- Maintain an adequate inventory of laboratory supplies and manage hazardous waste disposal.
- Preparation of media, reagents, and maintenance of microbial cultures used in testing.
- Participate in laboratory investigations, technology transfer, validations and R&D projects.
- Coordination or execution of equipment maintenance & calibration.
Experience & Skills Required
- 2-4 years of relevant Microbiology lab experience in a cGMP regulated environment.
- Must understand the fundamentals of gamma sterilization and knowledge of Sterility testing is a plus.
- Familiar with 21 CFR 210/211 & 820.
- Familiar with USP <61> and <62> (TAPC, Y/M and Specified Organism tests) and Antimicrobial effectiveness test. (AET) (USP 51)
- Familiar with Antibiotic assay using cylinder plate method. (USP 81).
- Excellent oral and written communication skills, strong interpersonal skills and superior organizational abilities.
- Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment.
- Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met.
- Strong computer skills utilizing Word, Excel, PowerPoint is essential.