MASTER JOB TITLE: Microbiology Technician
POSITION TITLE: Microbiology Technician
POSITION OBJECTIVE: Performs various microbiological sampling and testing in an FDA regulated environment.
REPORTS TO: Quality Control Microbiology Manager
Essential Job Functions/Responsibilities
- Perform environmental monitoring of ISO5/ISO7/ISO8 manufacturing areas (viable air, viable surface, and non-viable particulate) as well as inspection for compliance.
- Complete accurate and legible written data entry on records and documents for tests performed.
- Accurate computer data entry, trending, and presentation.
- Support Media Fill Validations, Engineering Validations and Cleaning Validations.
- Collection and testing (Bioburden/TOC/Conductivity) of water samples throughout the facility.
- Raw Material/Prefiltration Bioburden sample testing.
- Media check in and growth promotion.
- Equipment preparation and sterilization.
- Preparation of microbial ID samples.
- Off testing of incubated microbial media and plates.
- Use standard laboratory equipment including pH meter, balance, incubator, autoclave, pipettes, and water bath.
- Stocking/ordering lab supplies.
- Assess and revise microbiology/laboratory procedures as needed.
- Support in Sterility/Endotoxin/MET testing as needed.
- Support microbiology laboratory investigations including EE/Issue reviews/OOS/OOT/No Tests/DIR/CAPA.
- Promote and maintain safe and healthy working conditions in his/her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner.
- May perform other duties as assigned.
Required Education & Experience
- Bachelor’s in Microbiology/Biology or closely related field
- Associates Degree in Microbiology/Biology or closely related field with a minimum of 2 years relevant experience (working in a microbiology laboratory with experience in an FDA regulated biopharmaceutical /medical device industry)
- May consider candidates with a High School diploma (or equivalent) with a minimum of 4 years relevant experience.
Required Skills & Abilities:
- Upon hire, must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown. (required)
- Experience in microbiological principles and applications related to microbial ID, validation or clean room technology. (preferred)
- Accurate/legible completion of records and documents for tests performed, and accurate computer data entry.
- Training in cGMP/cGLP for laboratory operations and compliance to regulatory guidelines with working knowledge of environmental monitoring, endotoxin testing, USP sterility or bioburden test methods. (preferred)
- Proficient in the use of standard laboratory equipment including pH meter, balance, incubator, autoclave, pipettes or water bath. (preferred)
- Training to ISO, USP or GMPs standards. (preferred)
- Technology Skills (Windows, Word, Excel, Power Point). (preferred)
- Ability to wear high level aseptic gowning with face mask for long periods of time (required).
- Ability to stand for long periods of time (required).
- Must have a valid driver’s license for travel to other Athenex locations as needed.