QC Microbiology Analyst - Durham - Randstad Enterprise

    Randstad Enterprise
    Randstad Enterprise Durham

    2 days ago

    Description

    Quality Control Microbiologist II

    Location: Research Triangle Park (RTP), NC

    Shift: Sunday – Wednesday | 1st Shift (10-Hour Days)

    Foundation: A 4-year degree (B.S.) in Microbiology, Biology, or a related scientific field.

    Experience: Minimum of 2 years of hands-on experience in a GMP Microbiology laboratory.

    Mindset: A collaborative spirit and "quality-first" mentality. You have a sharp eye for detail and the analytical skills to catch a discrepancy before it becomes a problem.

    Flexibility: Availability to work the 4x10 Sunday–Wednesday schedule and a willingness to support the business with overtime when needed.

    The Opportunity

    Join our QC Microbiology team at our state-of-the-art drug substance manufacturing facility. In this role, you won't just be "testing samples"—you will be a vital guardian of patient safety. You will ensure the integrity of our manufacturing environment and the quality of the life-changing products we produce.

    We are looking for a detail-oriented scientist who thrives in a collaborative, fast-paced GMP environment and is eager to take ownership of critical buffer hold studies and environmental monitoring.

    Core Responsibilities

    • Microbiological Analysis: Perform bioburden and endotoxin testing on in-process samples and environmental/utility monitoring (EM) samples.
    • Data Integrity: Accurately record all testing and plate results in LIMS, ensuring strict adherence to SOPs, cGMPs, and safety guidelines.
    • Buffer Hold Studies: Lead the execution of ongoing buffer hold studies, serving as a key point of contact for Manufacturing Sciences.
    • Cross-Functional Coordination: Collaborate with the Microbiology Lead on scheduling and partner with Manufacturing to report results or excursions.
    • Compliance & Investigation: Monitor results against LIMS and SOP specifications; identify and initiate investigations for Out of Specification (OOS) or Out of Limit (OOL) results.
    • Lab Stewardship: Maintain a high-functioning lab environment by managing inventory levels and ordering supplies proactively.

    Technical Mastery:

    • Proven expertise in Bioburden and Endotoxin testing.
    • Strong Aseptic Skills and the ability to accurately perform microbial enumeration (CFU).
    • Proficiency using LIMS for data entry and result tracking.

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