POSITION OBJECTIVE: In an FDA regulated environment, perform various microbiological testing potentially including but not limited to: sample collection, water microbial and chemical testing, microbial swabbing, bioburden testing, environmental monitoring, endotoxin testing, Sterility testing, QC testing of media and equipment sterilization.
This is a first shift position. Projected hours are 9 AM to 5:30 PM, Monday through Friday. Start and end times may shift due to needs of production support.
Essential Job Functions/Responsibilities
- Perform environmental monitoring of manufacturing areas (viable air, viable surface and non-viable particulate).
- Must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown. Position requires the ability to wear high level aseptic gowning for long periods of time. Job may require standing for long periods of time.
- Perform bioburden and endotoxin testing of component, product and water samples.
- Conduct a variety of laboratory tests such as pH, water chemistry, media QC, and preparation of microbial ID samples.
- Use standard laboratory equipment including pH meter, balance, incubator, autoclave, pipettes and water bath.
- ·Accurate completion of records and documents for tests performed, and accurate computer data entry.
- Revision of microbiology/laboratory procedures.
- Support microbiology laboratory investigations. Support activities related to microbiology OOS/OOT/No Tests and CAPAs.
- Support sterilization validations such as preparation of validation samples, related paperwork and shipment of samples.
- Responsible for promoting and maintaining 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.
- Other projects as assigned.
Required Education & Qualifications
- Bachelor’s Degree in Microbiology/Biology or closely related field or 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 a FDA regulated or biopharmaceutical/medical device industry); may consider candidates with a High School diploma (or equivalent) with a minimum of 4 years relevant experience.
- Experience in microbiological principles and applications related to microbial ID, validation or clean room technology. (preferred)
- Training in cGMP for laboratory operations and compliance to regulatory guidelines with working knowledge of microbiology, endotoxin testing, environmental monitoring, 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, Access, Power Point, Project, Visio.). (preferred)
- Position requires the ability to wear high level aseptic gowning for long periods of time.
- Position may require standing for long periods of time.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.