Job Title: Quality Lab Associate I
Location: Round Lake, IL
Duration: 12 Months
Shift Schedule: 1st Shift - 8 AM to 5 PM, Monday to Sunday - Flexible. Saturday and Sunday hours required; holiday work required
Onsite only
Note:
Must not be allergic to Penicillin and cephalosporins or their related products and minerals.
Showers will be required when leaving the facility.
Summary:
Primarily support QC Microbiology Laboratory operations, 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.
- Conduct microbial analyses on raw materials, in-process, and finished products, and samples collected from the environmental monitoring programs and 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 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:
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.
- This is a first-shift Thursday-Monday position. Occasional off-shift and holiday work required.
Education and/or Experience:
Bachelor's degree in microbiology or biological science with a minimum of 2 years' experience in a laboratory setting.