Job Description

The Microbiology Analyst I, is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee is responsible for supporting the Microbiology and Environmental Monitoring (EM) department in implementing and managing the site’s microbiology and EM programs as well as the overall microbiology laboratory operations to ensure compliance with current regulations. This position requires direct interaction with the manufacturing processes related to biological non-sterile drug substance and sterile drug product. The employee’s qualification in aseptic gowning is required.

Essential Duties & Responsibilities

• Performs environmental monitoring of Kashiv-controlled and aseptic manufacturing areas.
• Collects samples for the detection of viable (surface, gowning, and air) and non-viable (air) particles.
• Incubates viable samples.
• Streaks and sends representative EM isolates to contract laboratory for identification. Receives results and performs data entry for trend analysis.
• Complies with annual gowning qualification.
• Performs sanitation and temperature verification of laboratory refrigerators and incubators.
• Performs routine monitoring for water for injection (WFI), reverse osmosis (RO), purified water (PW), and clean steam (CS) systems.
• Submits samples for testing to microbiology laboratory or contracted laboratory for TOC, conductivity, microbial count, and endotoxins.
• Performs routine monitoring of compressed air (CA) and nitrogen gas (N2) for viable particles, non-viable particles, and moisture.
• Performs bacterial endotoxin testing of WFI, CS, in process control (IPC), Intermediate product (IP), drug substance (DS), and drug product (DP) samples.
• Performs gram stain and growth promotion tests.
• Performs tests for bioburden and microbial limit.
• Performs visual inspection of microbiological, EM samples and media fill units.
• Performs data entry of results in Excel for trend analysis.
• Other tasks as requested by management.

Requirements

Education:

• A Bachelor’s degree in microbiology, biology, or related discipline.

Experience:

• 0-2 years of experience in a cGMP pharmaceutical manufacturing environment is preferred.

Special Skills:

• Good written and verbal communication skills.
• Good organizational skills.
• Detail oriented.
• Must be able to effectively manage time to complete assignments.
• Familiarized with the use of Microsoft Excel and Microsoft Word.

Work Environment & Physical Demands:

General Work Environment:

• General office setting and laboratory settings.
• Able to work wearing a full aseptic gowning at least 4 hours once weekly.
• Flexibility working weekend, holidays, or more than 8 hours a day, as required.
• Exposure to hazardous chemical, such as disinfectants, may occur, requiring personal protective equipment.
• Safety alertness is required due to work around hazardous equipment and conditions.

Noise:

• No extraordinary noise levels.

Standing/Lifting:

• Must be able to lift up to 25 lbs.

Visual:

• No special requirements.

Stress:

• High-paced demanding environment to meet ambition goals.

Travel:

• No travel required.

Supervisory Responsibility, if any No

This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.