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  • Sterility Assurance, Aseptic Process Monitor 3rd Shift - Bloomsbury - QuVa Pharma

    QuVa Pharma
    QuVa Pharma Bloomsbury

    1 week ago

    Quva Pharma background
    Description

    Job Description:

    Our Sterility Assurance (SA), Aseptic Process Monitor plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products.

    The SA Aseptic Process Monitor is responsible for being the dedicated QA person in the clean room during media fills to ensure good aseptic practices, ensuring units are collected, documented, and tested appropriately. The person is also responsible for ensuring Environmental/Personnel Monitoring (EM/PM) sampling is occurring and incubated.

    The SA Aseptic Process Monitor monitors the compounding activities to assess aseptic behavior in the clean room and provides compounder feedback if concerns are found.

    Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

    Responsibilities:

    • Ensures company compliance to QuVa Pharma's Standard Operating Procedures (SOPs) and Quality Management System (QMS)
    • Schedules and proctors media fills; observes technicians in compounding and routine clean room activities
    • Reviews EM/PM data to identify any potential trends
    • Provides qualification support for personnel on appropriate gowning techniques, aseptic techniques, including execution of Compounder and MQA EM Specialist Competency Assessments, as well as qualification support for clean room cleaning
    • Performs reading of media aseptic process simulations and EM/PM plates and accounting of all units
    • Performs EM/PM sampling as needed; maintains EM/PM records
    • Maintains Media Fill and Gown Qualification/Requalification records
    • Provides support for sterility investigations, including EM/PM excursions and review of deviations and investigations
    • Assists in generating Sterility Assurance reports and documents
    • Follows all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function
    • Works in accordance with area supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs)
    • Supports department supervision in oversight and prioritization of day-to-day responsibilities
    • Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP
    • Demonstrates a high level of discretion in the timely identification and resolution of events potentially impacting the Quality of products and processes
    • Evaluates batches/product for compliance with defined specifications

    Requirements:

    • A High School diploma or equivalent
    • Ability to successfully complete a drug and background check
    • At least 2 years' experience in Quality Assurance, Microbiology, Sterile Compounding in pharmaceutical manufacturing
    • Previous training and experience in environmental monitoring and sampling
    • Thorough understanding of 21 CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic Processing
    • Strong Microsoft Word and Excel skills
    • Must be currently authorized to work in the United States on a full-time basis; QuVa will not sponsor applicants for work visas

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