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Form of workJob Description
Title:Microbiologist II
Location: Chicago, IL
Hire Type: Contract-to-Hire
Overview:
Sterling has helped build careers for thousands of professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S.
As a contract employee of Sterling, you are eligible to receive aFull Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.
Job Summary:
The Microbiologist II 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 gown is required.
Job Duties:
- Performs environmental monitoring of TPI-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.
- 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, oil, 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.
- Performance 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.
- Reviews microbiology laboratory data.
- Generates OOS or Out of EM Action/Alert Levels Notification, when required.
- Lead laboratory investigations and/or support manufacturing investigations, when required.
- Generate change controls for Equipment/Instruments qualifications, Process or Document Changes.
- Lead procedures, methods or specifications revisions acting as Contributor using Master Control Systems.
- Other tasks as requested by management.
Qualifications:
- Bachelor's Degree in Microbiology, Biology, or a related discipline.
- At least 3-5 years of experience in a cGMP pharmaceutical manufacturing environment is required.
- Working knowledge of cGMP regulations (21 CFR 201/211/820) is required.
- Good written and verbal communication skills.
- Use of air sampling EM equipment such as AirIdeal, HACH Met Ones 3340 Series, Lasair III, and MiniCapt is helpful.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identify, national origin, disability, protected veteran status, or genetic information.
