Job Description
Monday to Friday 8am to 5pm
USP 61 & 85 Testing
Will need to have one year professional experience (not including college labs)
Lab testing exp.
Pharmaceutical experience
PRINCIPAL ACCOUNTABILITIES: (The major activities or end results necessary to fulfill the position requirements on an ongoing basis)
Has a sound understanding of the skills required to perform the following routine testing activities: Microbiological Assays and Testing–
a) Turbidimetric/Chromogenic/Gel Clot method for the detection of bacterial endotoxins;
b) Microbial Limits Test/Bioburden determination, manipulation, and maintenance of ATCC microorganisms and microbial isolates;
c) Sterility Test, Growth Promotion and Particulate Matter determination using instrumentation and/or microscopy;
d) Identification of bacteria and fungi using microscopy and phenotypic/genotypic methods;
e) 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 *** 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 a) clean steam, USP water, and Water for Injection for bioburden, total organic carbon (TOC), and presence of endotoxins; and b) 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 *** 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
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Job Tags
Contract work, Local area, Monday to Friday,