PRINCIPAL ACCOUNTABILITIES
* Turbidimetric/Chromogenic/Gel Clot method for the detection of bacterial endotoxins
* Microbial Limits Test/Bioburden determination, manipulation, and maintenance of ATCC microorganisms and microbial isolates
* Sterility Test, Growth Promotion and Particulate Matter determination using instrumentation and/or microscopy
* Identification of bacteria and fungi using microscopy and phenotypic/genotypic methods
* Perform sample shipments to contract testing laboratories
Validation Support
* Ability to perform bioburden swab testing by current detection methods.
* Ability to perform biological indicator testing by current methods.
* Ability to perform endotoxin challenge vial testing.
GMP Documentation
* Document test results and conclusions in a GMP manner
* Ensure test forms are complete before submission for approval
* Data entry for finished products and raw material in Laboratory Information Management System
* Performs responsibilities in compliance with company quality systems and regulatory requirements
* Adheres to all company safety, health and environmental policies, procedures, and directives
* Conducts all laboratory activities in a safe manner by use of SDS and Safety Notifications to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel
* Ensures all equipment is in a GMP/validated/calibrated state before use
Technical Writing
* Develop and execute protocols and Standard Operating Procedures for the implementation of microbiology equipment, assays and test methods
* Reviews data generated by laboratory personnel
* Provides guidance and training to other laboratory personnel on operation of instruments and performing test methods
* Ability to troubleshoot instruments in the event of any problems
* Utilizes classical microbiological methods for the identification of microorganisms per current version of Bergey’s Manual of Systematic Bacteriology
Support of Environmental Monitoring Program
* Utilities –Testing of clean steam, USP water, and Water for Injection for bioburden, total organic carbon (TOC), and presence of endotoxins; and nitrogen and process air for total microbial count and total particulates
* Environmental Monitoring of facilities for non-viable particulates, viable air and surface by use of calibrated and validated monitoring equipment and procedures.
Other Responsibilities
* Performs responsibilities in compliance with company quality systems
* Adheres to all company safety, health and environmental policies, procedures and directives
* Conducts all laboratory activities in a safe manner by use of SDS to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel
* Data analysis and entry into software systems such as Microbiology Information Management Systems
STRATEGIC FOCUS
The focus desired and expected on the position over the next 1-3 years
* Perform responsibilities in compliance with company quality systems and provide support to all manufacturing activities
* Adhere to all company environmental, health and safety policies and procedures
* Conduct all laboratory and cleanroom activities in a safe manner and according to appropriate written procedures.
* Perform microbiological assays according to US, EU, ISO regulations and company procedures and test methods
* Maintain the laboratory metrics program. Complete the qualification of sanitizers used in the manufacturing facilities.
EXPERIENCE
* One year professional experience (not including college labs)
* Lab testing experience
* Pharmaceutical experience
Company Description
Dynamic Engineering firm with incredible team culture and long term growth opportunities!
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