Quality Laboratory Associate I

Job title Quality Laboratory Associate I
Contract duration 4+ Months
Work location - Round Lake, IL
Work arrangement - Onsite

Summary:
Primarily support QC Microbiology Laboratory operations at the client's facility in Round Lake, IL.
This position encompasses biological testing support for pharmaceutical products (biologics and
drugs) through all stages of the manufacturing process including incoming raw materials, in-
process samples, and finished products and includes facility environmental and critical systems
microbiological monitoring.

Responsibilities:
This section contains a list of five to eight primary responsibilities of this role that account
for the majority of the work. The incumbent will perform other duties assigned.
Conduct microbial analyses on raw materials, in-process, and finished products, and samples
collected from the environmental monitoring programs and client's manufacturing facility.
Conduct routine facility environmental monitoring (i.e., surfaces, air, particulate and personnel
monitoring) and critical systems monitoring (i.e., water, clean steam, process compressed air
and nitrogen).
Prepare media and reagents used within the laboratory.
Use laboratory instrumentation (i.e., particle counters, pH meter, SAS, Autoclave) and
computer systems (i.e., LIMS) to collect and record data.
Monitor inventory of supplies, equipment, reagents and media. Order, receive and stock
supplies as necessary.
Maintain a clean, safe and organized laboratory area and perform regular laboratory
housekeeping activities.
Conduct and document laboratory and nonconformance investigations, including data review,
root cause analysis, impact assessment, and development of appropriate corrective and
preventive actions.
Maintain data integrity and ensure compliance with company standard operating procedures,
FDA, QSR and cGMP regulations.
Follow, understand and comply with the client's procedures and policies on cGMP's and safety.
Contribute to other laboratory tasks and projects as assigned.
Will work in both Drug Delivery and Penicillin facilities as needed.

Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty
satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations
may be made to enable individuals with disabilities to perform essential functions.
Must not be allergic to Penicillin and Cephalosporin or their related products and minerals.
Background knowledge in basic Biology and Microbiology principles including aseptic technique
is required.
Proficient in LIMS (laboratory information management systems).
Ability to handle multiple tasks concurrently, and in a timely fashion. Must be detail oriented,
conscientious and have high reading comprehension skills.
Knowledge of GLP and pharmaceutical aseptic processing cGMP requirements is preferred but
not required.
Demonstrated technical writing skills and knowledge of structured root cause investigation
methodologies, including DMAIC (Define, Measure, Analyze, Improve, Control).
Ability to work independently and as part of a team.
Self-motivation, adaptability and a positive attitude in a highly dynamic environment.
Ability to lift up to 50 pounds when required.

Experience:
Include the education and experience that is necessary to perform the job satisfactorily.
Bachelor's degree in microbiology or biological science with minimum of 2 years experience in a
laboratory setting.
Important Do not provide AI-generated summaries or short 1 2 line descriptions. Include the original responsibilities, required qualifications, technical skills, domain experience, and any client-specific requirements.
Required qualifications microbial analyses
LIMS
Use laboratory instrumentation
FDA, QSR and cGMP regulations.
Must not be allergic to Penicillin and Cephalosporin or their related products and minerals.
Background knowledge in basic Biology and Microbiology principles including aseptic technique
is required.
DMAIC




Must-have skills
Years of experience required 4+ Years
Education required Bachelor's degree in microbiology or biological science