Quality Assurance Inspector - Marietta - Alora Pharmaceuticals

    Alora Pharmaceuticals
    Alora Pharmaceuticals Marietta

    1 day ago

    Description

    Join our team as a Quality Assurance Inspector, where you'll play a vital role in maintaining the high standards of our production processes. As a key member of our quality team, you will be responsible for ensuring compliance with cGMP regulations, supporting critical manufacturing and packaging activities, and contributing to the overall quality of our products. Your presence and vigilance on the production floor will help uphold our commitment to excellence.

    DUTIES AND RESPONSIBILITIES

    • Be present on the production floor to provide comprehensive quality oversight for critical manufacturing and packaging processes.
    • Conduct QA release inspections, line clearances, and AQL checks on products.
    • Review logbooks and in-process batch records on-site to ensure compliance.
    • Manage Label Control functions, including testing, issuance, and reconciliation.
    • Assist with the application and removal of operational tags such as pallet tags, Hold tags, and equipment out-of-service tags.
    • Review batch records meticulously for accuracy.
    • Gather and organize data for Annual Product Reviews and other projects as directed by management.
    • Identify discrepancies and ensure timely initiation of investigations.
    • Effectively communicate complex quality issues to management.
    • Support the creation and revision of SOPs to align with current practices.
    • Assist during FDA and other regulatory inspections.
    • Adhere to all company quality systems and comply with environmental, health, and safety regulations.
    • Stay informed of current regulatory requirements relevant to drug product manufacture and packaging.
    • Handle document control functions as necessary.
    • Conduct annual inspections of retain samples.
    • Release product contact supplies efficiently.
    • Sample incoming raw materials and manage raw material retesting processes.
    • Test incoming printed materials against established quality specifications.
    • Perform additional duties as assigned by management.

    EXPERIENCE AND QUALIFICATIONS

    • A High School Diploma or equivalent is required; technical school certificate is a plus.
    • Minimum of two years of experience in a GMP manufacturing environment within the pharmaceutical or biotech industry.
    • Strong understanding of GMP production and inspection processes.
    • Demonstrated application of cGMP and industry practices.
    • Exceptional written and verbal communication skills.
    • Able to effectively manage multiple tasks.
    • Capable of working independently while making informed decisions.
    • Detail-oriented with the ability to juggle multiple projects simultaneously.
    • Proficient in Microsoft Office applications, including Word and Excel.

    Preferred Experience / Skills

    • Prior experience in Quality Assurance is highly desirable.

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