Chicago, IL 60616 US
Job Title: Microbiology Analyst
Location: Chicago, IL 60616
Type: Contract to Hire
The Microbiology Analyst I is a regular employee in a full-time exempt position based in Chicago, IL. This position is responsible for supporting the Microbiology and Environmental Monitoring (EM) department in implementing and managing the site's microbiology and EM programs, ensuring compliance with current regulations. The Microbiology Analyst I will have direct involvement with the manufacturing processes related to biological non-sterile drug substances and sterile drug products
- Performing environmental monitoring of controlled and aseptic manufacturing areas.
- Collecting samples for the detection of viable (surface, gowning, and air) and non-viable (air) particles.
- Incubating viable samples.
- Streaking and sending representative EM isolates to a contract laboratory for identification. Receiving results and performing data entry for trend analysis.
- Complying with annual gowning qualification.
- Performing sanitation and temperature verification of laboratory refrigerators and incubators.
- Conducting routine monitoring for water for injection (WFI), reverse osmosis (RO), purified water (PW), and clean steam (CS) systems.
- Submitting samples for testing to a microbiology laboratory or contracted laboratory for TOC, conductivity, microbial count, and endotoxins.
- Performing routine monitoring of compressed air (CA) and nitrogen gas (N2) for viable particles, non-viable particles, and moisture.
- Performing bacterial endotoxin testing of WFI, CS, in-process control (IPC), intermediate product (IP), drug substance (DS), and drug product (DP) samples.
- Performing gram stain and growth promotion tests.
- Performing tests for bioburden and microbial limit.
- Performing visual inspection of microbiological and EM samples and media fill units.
- Performing data entry of results in Excel for trend analysis.
- Completing other tasks as requested by management.
- A Bachelor's degree in microbiology, biology, or a related discipline.
- Some experience in a cGMP pharmaceutical manufacturing environment is preferred.
- Experience with Aseptic gowning is required for this role
Meet Your Recruiter
Mike Schmitz is an esteemed Recruiting Team Leader specializing in the Life Sciences Division. With an impressive tenure of over 12 years at Sterling and a remarkable 16-year career in the recruiting arena, Mike has cemented his reputation as a trailblazer in talent acquisition.
As a Recruiting Team Leader, Mike's understanding of the intricacies within the Life Sciences Division is unparalleled. His expertise positions him as a strategic partner in bridging the gap between talented professionals and opportunities that align with their aspirations.
With a career spanning 16 years, Mike's journey in the recruitment landscape has been defined by his dedication to facilitating more fulfilling careers for skilled professionals. His ability to understand everyone’s unique strengths and match them with roles that foster growth and satisfaction marks him as a true advocate for professional development.
Mike's advice to candidates reflects his commitment to helping them excel: approach every job interview with positivity and authenticity. He firmly believes that a positive attitude and an engaging personality are pivotal in creating lasting impressions. Mike emphasizes that while technical qualifications are crucial, the ability to connect with interviewers and present oneself effectively is equally valuable to prospective employers.