Quality Lab Associate I

DivIHN Integration Inc; Round Lake (IL); On-site; USD 30,000 - 39,000; Full time

Job summary

DivIHN Integration Inc is seeking a QC Microbiology Laboratory technician to support microbiology operations at the Client Manufacturing facility in Round Lake, IL. The role involves testing raw materials, in-process samples, and finished products, as well as environmental monitoring across pharmaceutical processes and related systems.

Primary duties include performing microbial analyses, maintaining lab accuracy, preparing media, handling LIMS data, and ensuring compliance with FDA, QSR, and

Qualifications

• Bachelor’s degree in microbiology or biological science with minimum 2 years experience in a laboratory setting.
• Experience in aseptic/pharmaceutical microbiology desired.
• Proficiency with laboratory information management systems (LIMS).

Responsibilities

• Conduct microbial analyses on raw materials, in-process, finished products, and samples from environmental monitoring programs and the facility.
• Perform routine facility environmental monitoring (surfaces, air, particulate, personnel) and critical systems monitoring (water, clean steam, process compressed air and nitrogen).
• Prepare media and reagents used in the laboratory.
• Operate laboratory instrumentation (particle counters, pH meter, SAS, Autoclave) and data systems (LIMS) to collect and record data.
• Monitor inventory and stock supplies; order, receive, and stock as needed.
• Maintain a clean, safe, and organized laboratory environment and perform housekeeping.
• Conduct and document laboratory and nonconformance investigations, including root cause analysis and CAPA development.
• Maintain data integrity and compliance with SOPs, FDA, QSR, and cGMP regulations.
• Follow Client procedures and safety policies on cGMPs and safety.
• Contribute to other laboratory tasks and projects as assigned.
• Will work in Drug Delivery and Penicillin facilities as needed.

Skills

Aseptic technique

Detail-oriented

Reading comprehension

Independent and team work

Education

Bachelor’s degree in microbiology or biological science

Tools

LIMS

Job description

Schedule: Wednesday–Sunday, with some flexibility such as Thursday–Monday, 7:00 AM – 3:30/4:00 PM or 8:00 AM – 5:00 PM. Saturday and Sunday hours required, occasional off-shift/holiday work may be required

Note: Must not be allergic to Penicillin and Cephalosporin or their related products and minerals. Showers will be required when leaving facility.

Only W2 candidates are eligible for this position. Third party or C2C candidates will not be considered.

Job Description:

Summary:

This section focuses on the main purpose of the job in one to four sentences.

Primarily support QC Microbiology Laboratory operations at the Client Manufacturing 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.

Essential Duties and 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 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 Client 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.
• Experience: Ideally 1–2 years in aseptic/pharmaceutical microbiology; candidates with roughly 1–5 years may be considered.
• 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.This is a first-shift Thursday-Monday position. Occasional off-shift and holiday work required.
• Key Testing: Environmental monitoring (surface/air/personnel), water/critical systems, bioburden, bacterial endotoxin, sterility testing, membrane filtration, plate/colony counting, and finished/in-process product testing.
• Level: Primarily an entry-level/routine testing role; candidates with extensive experience (5–10+ years) may be considered overqualified.

Education and/or 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.

Focus:

Routine QC microbiology testing in a pharmaceutical/aseptic manufacturing environment.

Education: Bachelor’s degree in Science required; Biology/Microbiology preferred. Master’s acceptable; PhD overqualified.