Quality Lab Associate I

Lancesoft; Round Lake (IL); On-site; USD 55,000 - 75,000; Full time

Job summary

Lancesoft is seeking a QC Microbiology Analyst to support manufacturing at the Round Lake, IL facility. You will conduct microbial testing on raw materials, in-process samples and finished products, and participate in environmental monitoring per cGMP.

Responsibilities include using LIMS and lab instruments, maintaining data integrity and assisting with investigations. A Bachelor’s in microbiology or biological science and 2 years of lab experience are required; lifting up to 50 pounds may be

Qualifications

• Must be able to perform essential duties satisfactorily.
• Background knowledge in biology and microbiology principles including aseptic technique.
• Proficient in LIMS (laboratory information management systems).
• Ability to lift up to 50 pounds.
• Must not be allergic to Penicillin and Cephalosporin or their related products and minerals.

Responsibilities

• Conduct microbial analyses on raw materials, in-process, and finished products, and samples from environmental monitoring programs and the facility.
• Conduct routine facility environmental monitoring (surfaces, air, particulates, personnel) and critical systems monitoring (water, clean steam, process gas).
• Prepare media and reagents used within the laboratory.
• Use laboratory instrumentation (particle counters, pH meter, SAS, Autoclave) and computer systems (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 corrective actions.
• Maintain data integrity and ensure compliance with SOPs, FDA, QSR and cGMP regulations.
• Follow, understand and comply with procedures and safety.
• Contribute to other laboratory tasks and projects as assigned.
• Work in both Drug Delivery and Penicillin facilities as needed.

Skills

Laboratory testing

Quality control

GMP knowledge

Data integrity

Documentation

Troubleshooting

Education

Bachelor's degree in Microbiology or Biological Sciences

Minimum 2 years laboratory experience

Tools

LIMS

SAS

pH meter

Autoclave

Particle counters

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 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 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

• 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.


• 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 minimum of 2 years experience in a laboratory setting.