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Fremont

    QC Associate IV - Fremont, United States - Fladger Assoc. Inc.

    Fladger Assoc. Inc.
    Fladger Assoc. Inc. Fremont, United States

    6 days ago

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    Description

    Job Description

    Job DescriptionFremont, CAContract Duration: 12-24 monthsRate: Negotiable

    Responsibilities:

    • Excellent employment opportunity for a QC Associate IV in the Fremont, CA area.
    • Reviews raw material lot packages and releases RM lots for GMP manufacturing use.
    • Ensures lot release timelines will be met and coordinates testing performed at in-house and contract laboratories.
    • This includes, but not limited to, preparation of sample submission forms, performing necessary LIMS and SAP transactions, review of test records, tracking status of samples and their respective tests, etc.
    • Review, author, and edit documents, including deviations, change control requests, SOPs, test methods, material specifications, analytical investigations, and laboratory test plans and related technical reports.
    • Interacts with functional groups within and outside of QC and recognition of issues that require elevation to upper management.
    • Performs tasks and activities related to supplier/material qualifications and supplier change notifications (e.g., review of vendor documentation, review of vendor and material history, etc.)
    • Performs logbook and/or LIMS entries when using equipment/instruments.
    • Reconciles samples.
    • Perform weekly and monthly reviews of appropriate forms (e.g., test records) and logbooks.
    • Assists with QC's data management, including data review and trending.
    • Maintains specific QC files and database records for process and/or quality improvement efforts.
    • Maintain laboratory cleanliness and orderliness.
    • Cross-train in other RM duties to cover for other RM members when needed.

    Experience:

    • Bachelors' Degree
    • Six (6) years cGMP or appropriate experience required.
    • Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859 or other sampling standards required.
    • Strong technical writing required
    • Knowledge of CFR, USP, and ICH required.
    • Knowledge of SAP, Trackwise and LIMS desired.
    • Working knowledge of Microsoft Office systems, LIMS, lab instrumentation and other relevant systems
    • Demonstrated problem-detection and problem-resolution skills required
    • Lifting, carrying, pushing or pulling up to 50 pounds occasionally
    • Frequent periods of sitting, walking, and standing
    • Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat
    • Occasional low-level work, fine finger dexterity/ including grasping or pinching required
    • Occasional use of personal protective equipment
    • Required Skills: LIMS, DATABASES, TRACKWISE, SOP, GMP,
    • Additional Skills: ICH/GCP, MICROSOFT OFFICE, ANSI, CHANGE PROCESS MANAGEMENT, CHARTING, DATA MANAGEMENT, RECONCILIATION, SAMPLING
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