Microbiologist
Company: iLABS (Innovation Labs) Inc.
Location: Mahwah
Posted on: June 24, 2022
Job Description:
Microbiologist
Overview:The Microbiologist is responsible for the implementation
of the microbiological control program at iLabs to ensure
production meets the requirements of the microbiological standards
and operating procedures. Microbiological control programs include,
but are not limited to: Current Good Manufacturing Practices
(cGMPs), environmental monitoring, raw materials, bulk and finished
product testing & release, and corrective and preventive
actions.
Job Type: Full-time
Functions:
- Demonstrates the use of aseptic technique
- Must utilize proper personal protective equipment (PPE) when
handling all samples as well as biohazard
- Performs Microbiological testing of Raw Materials/Bulk
Products/Finished Products, stability for R&D samples and
documentation as per procedure
- Performs microbiological testing related for the following
microbiological test methods: Microbial Enumeration and Specified
Microorganism (MET/SMT) testing per USP 60, 61/62
- Performs Antimicrobial Effectiveness Testing (AET) per USP
51
- Performs Preservative Effectiveness Testing (PET) per USP
51
- Sampling and Microbiological testing of water as per the
procedure
- Performs Purified/Source Water testing per USP 1231
- Performs plate reads and incubations
- Performs stock culture maintenance and Gram Staining
- Performs environmental monitoring activity as per the
procedure
- Prepares culture medias and performs growth promotion testing
on media as per SOPs
- Glassware Washing and General Housekeeping and Disinfection of
Lab Area.
- Maintaining laboratory inventory
- Monitor/perform internal verification of pH meter, analytical
balance, incubators, thermometers, autoclave, refrigerators,
Biological Safety Cabinet, etc.
- Keeps current with FDA, ISO, EU and cGMP standards and industry
trends
- Maintain and improve lab documents and record keeping
procedures
- Handling of Biohazard
- Ensure the interpretation of the data is correct and the
results are effectively communicated to appropriate groups
- Prepares, updates or assists in the revision of SOP's, training
documentation and departmental forms to reflect current laboratory
practices
- Writing/conducting investigations when necessary
- Cross-trains to ensure full functionality on all laboratory
equipment and methods
- Trains other employees in the microbiology techniques, SOP's,
GMP's, administrative and safety procedures in the laboratory as
required.
- Saturday hours to support manufacturing
Qualifications:
- Bachelors Degree in Microbiology, Biochemistry, Biology or
related disciplines is required
- Three years or more in a cGMP laboratory or manufacturing
environment, with two years or more in a cGMP Quality organization
is helpful but not required
- Must have GMP and Quality knowledge
- Must be able to interpret problems and effectively prepare
surrounding communication in a productive manner to management with
clarity and accuracy
- Must be skilled in time management.
Keywords: iLABS (Innovation Labs) Inc., Paterson , Microbiologist, Other , Mahwah, New Jersey
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