• Round Lake, IL
    2 days ago

    Job Description

    Details:

    Stefanini Group is hiring!

    Stefanini is looking for QC Microbiologist in Round Lake, IL

    For quick Apply, please reach out to Rachit Rastogi - call: 2489360662/ email: rachit.rastogi@stefanini.com

    Work Hours: Wednesday/Thursday-Monday (40 hours)

    Work Location: Round Lake, IL

    Shift: 1st Shift - (7:00 AM to 4:00 PM or 8:00 AM to 5:00 PM) - Flexible.

    Shift Schedule - (Wednesday/Thursday to Monday) - Saturday and Sunday hours required. Occasional off-shift and holiday work required.

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

    Primarily support QC Microbiology Laboratory operations at the Manufacturing facility. 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 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''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.

    Numbers & Facts

    LocationRound Lake, IL

    Skills

    • Autoclaveunmatched
    • Biotech and Pharmaceuticalunmatched
    • Computer Systemsunmatched
    • Corporate Complianceunmatched
    • Corrective Actionunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Data Collectionunmatched
    • Data Qualityunmatched
    • Environmental Monitoringunmatched
    • Environmental Workunmatched
    • FDA (Food and Drug Administration)unmatched
    • Housekeeping/Cleaningunmatched
    • Instrumentationunmatched
    • Laboratory Information Management System (LIMS)unmatched
    • Laboratory Operationsunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing/Industrial Processesunmatched
    • Materials Analysisunmatched
    • Microbiologyunmatched
    • Organizational Skillsunmatched
    • Product Supportunmatched
    • Quality Controlunmatched
    • Quality System Requirements (QSR)unmatched
    • Regulationsunmatched
    • Root Cause Analysisunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Testingunmatched

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