APPLICATION REQUIREMENTS:

• Your cover letter should give clear examples of the following:
• An instance in which you demonstrated an exceptional work ethic
• An instance in which you demonstrated a willingness to do work that others thought was menial in order to win
• An instance in which you demonstrated honesty despite it not being in your immediate best interest
• Your application must include an undergraduate transcript in order to be considered
• This job is not 9-5
• This is an opportunity to work very hard, learn a lot, and develop skills that will serve you well later in life
• This is not an opportunity to focus on work life balance

ABOUT THE ROLE

We are seeking a highly motivated and detail-oriented Research Associate to join our Microbiology team. The successful candidate will be responsible for sterility testing and endotoxin testing on pharmaceutical products. The role may include both traditional USP <71> methods and USP <1223> alternative rapid microbiological testing. The role will also include endotoxin testing using Endosafe. Work is conducted on-site in a lab/clean/room setting that will require sterile gowning while in the lab.
You are a good fit for this role if you: work hard, are ambitious, have a very high attention to detail, and will do whatever it takes to win.

KEY RESPONSIBILITIES:

• Perform sterility testing of drug products, raw materials, and components using membrane filtration or direct inoculation methods per USP <71> and alternative rapid methods validated under USP <1223>.
• Conduct bacterial endotoxin testing using CRL Endosafe according to USP <85>
• Prepare, handle, and incubate media and test systems under aseptic conditions in a cleanroom or isolator environment.
• Handle microbial cultures including test strains (e.g., S. Aureus, P. paraeruginosa, C. Albicans, B. Subtillis, etc.) for growth promotion and suitability testing.
• Support qualification and routine monitoring of cleanrooms, isolators, biosafety cabinets, and autoclaves.
• Accurately record data, maintain laboratory notebooks, and ensure traceability of all records in accordance with Good Documentation Practices (GDP).
• Assist in deviation investigations, OOS/OOT assessments, and CAPA implementations related to microbiological testing.
• Contribute to method qualification/validations and periodic verification of testing methods.
• Follow SOPs, protocols, and regulatory guidance to ensure all work performed in a compliant and scientifically sound manner
• Participate in equipment maintenance, calibration, and laboratory housekeeping activities.

OTHER RESPONSIBILITIES

This job description is not intended to be all-inclusive. From time to time you may be required to perform other related duties as assigned to meet operational needs.