Los Angeles Metro Area, CA
1) Friday - Sunday: 10am - 10pm (Weekend Shift) 2) Monday - Friday: 6am - 2:30pm (Day Shift)
Responsible for performing material handling functions to support all internal and external customers in an accurate and timely manner.
These functions include but are not limited to shipping and receiving, material stocking, material issuance, cycle counting, inventory reconciliation, chemical/biohazardous waste handling, product handling in temperature-controlled environment, general housekeeping, and maintaining accurate clerical records in a GMP-regulated environment.
Perform microbiological (AML) and endotoxin (LAL) testing on water samples, in-process product samples, raw materials, and environmental monitoring (EM) samples as directed by the laboratory supervisor or Senior Microbiologist.
Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods.
Count colony forming units (CFU) on Petri plates.
Perform sterility testing on final products and raw materials.
Perform Growth Promotion and Biological Indicator testing.
Isolate and maintain pure microbial cultures from test samples.
Prepare and maintain frozen cultures of microbial isolates.
Perform various microbial identification tests (microscopy, genetic, biochemical, and/or morphological).
Maintain microbial identification database.
Compile and enter data into computer database (i.e. LIMS - Laboratory Information Management Systems) to be used for reporting and trending purposes.
Review test results against specifications.
Will share general responsibilities for laboratory equipment maintenance and calibration, housekeeping, and other lab support functions (e.g., inventory of consumables and reagents).
Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples.
Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.
Related experience in a pharmaceutical, GMP, or FDA regulated testing laboratory is preferred.
Requires a basic understanding of the fundamentals of microbiology, aseptic techniques, isolation and identification of molds, yeasts, and bacteria, as well as basic statistical analysis.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Must be proactive, results oriented, and have strong attention to detail.
Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Excellent verbal and written communication skills in the English language.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Specific experience with LIMS (Laboratory Information Management System) is preferred.
Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
Bachelor s degree in Microbiology, Biology, or closely related scientific discipline is required.
Notification of Hep B Vaccine required.