Quality Lab Associate

Job Description

Title: Quality Lab Associate

\n

\n

Location: Round Lake, IL

\n

\n

Duration: 12 Months+ Possible Extension

\n

\n

Schedule: Onsite- 1st Shift - 8AM to 5PM Wednesday to Sunday - Flexible. Saturday and Sunday hours required

\n

\n

Notes:

\n

\n
• Must not be allergic to Penicillin and Cephalosporin or their related products and minerals.

\n

• Showers will be required when leaving facility.

\n

• Holiday work required

\n

\n

\n

Summary:

\n

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

\n

• Primarily support QC Microbiology Laboratory operations.

\n

• 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.

\n

\n

\n

Essential Duties and Responsibilities:

\n

\n
• This section contains a list of five to eight primary responsibilities of this role that account for the majority of the work.

\n

• The incumbent will perform other duties assigned.

\n

• Conduct microbial analyses on raw materials, in-process, and finished products, and samples collected from the environmental monitoring programs and client manufacturing facility.

\n

• 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).

\n

• Prepare media and reagents used within the laboratory.

\n

• Use laboratory instrumentation (i.e., particle counters, pH meter, SAS, Autoclave) and computer systems (i.e., LIMS) to collect and record data.

\n

• Monitor inventory of supplies, equipment, reagents and media. Order, receive and stock supplies as necessary.

\n

• Maintain a clean, safe and organized laboratory area and perform regular laboratory housekeeping activities.

\n

• Conduct and document laboratory and nonconformance investigations, including data review, root cause analysis, impact assessment, and development of appropriate corrective and preventive actions.

\n

• Maintain data integrity and ensure compliance with company standard operating procedures, FDA, QSR and cGMP regulations.

\n

• Follow, understand and comply with client procedures and policies on cGMP’s and safety.

\n

• Contribute to other laboratory tasks and projects as assigned.

\n

• Will work in both Drug Delivery and Penicillin facilities as needed.

\n

\n

\n

Qualifications:

\n

\n
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

\n

• List knowledge, skills, and/or abilities required.

\n

• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

\n

• Must not be allergic to Penicillin and Cephalosporin or their related products and minerals.

\n

• Background knowledge in basic Biology and Microbiology principles including aseptic technique is required.

\n

• Proficient in LIMS (laboratory information management systems).

\n

• Ability to handle multiple tasks concurrently, and in a timely fashion. Must be detail oriented, conscientious and have high reading comprehension skills.

\n

• Knowledge of GLP and pharmaceutical aseptic processing cGMP requirements is preferred but not required.

\n

• Demonstrated technical writing skills and knowledge of structured root cause investigation methodologies, including DMAIC (Define, Measure, Analyze, Improve, Control).

\n

• Ability to work independently and as part of a team.

\n

• Self-motivation, adaptability and a positive attitude in a highly dynamic environment.

\n

• Ability to lift up to 50 pounds when required.

\n

• This is a first-shift Thursday-Monday position. Occasional off-shift and holiday work required.

\n

\n

\n

Education and/or Experience:

\n

\n
• Include the education and experience that is necessary to perform the job satisfactorily.

\n

• Bachelor’s degree in microbiology or biological science with minimum of 2 years experience in a laboratory setting.

\n