Quality Control Inspector - Portland - Planet Pharma

    Planet Pharma
    Planet Pharma Portland

    5 hours ago

    $40,000 - $70,000 (USD) per year *
    Description

    The Inspector performs basic routine inspection of electronic, electro-mechanical and/or mechanical materials, components and sub-assemblies received, in process of manufacture, or manufactured, for conformance with quality assurance standards.

    Key Job Duties and Responsibilities:

    Inspection & Testing: Performs visual and physical inspections of raw materials, in-process components, and finished products to ensure they meet quality specifications. Uses precision measuring tools and lab equipment to verify product dimensions and performance.

    Documentation & Compliance: Accurately maintains Lot History Records (LHR), batch records, and inspection logs in compliance with Good Documentation Practices (GDP) and FDA regulations.

    Defect Management: Identifies, classifies, and reports defects. Manages non-conforming material by initiating Non-Conformance Reports (NCR) and assisting with investigations.

    Process Control: Monitors production processes to ensure adherence to standard operating procedures (SOPs) and Good Manufacturing Practices (GMPs).

    Equipment Maintenance: Calibrates, cleans, and performs routine maintenance on inspection and testing equipment to ensure accuracy.

    Collaboration: Works with production and engineering teams to support quality improvements, provide feedback on product quality, and ensure regulatory compliance.

    Key Competencies:

    Attention to Detail: High level of accuracy in documentation and inspection.

    Computer Literacy: Proficient in using software like SAP, POMS, or Laboratory Information Management Systems (LIMS).

    Technical Knowledge: Understanding of ISO 13485 and FDA 21 CFR Part 820 regulations.

    Communication: Ability to clearly report deviations and collaborate in a team environment.

    Common Educational/Experience Requirements:

    High school diploma or equivalent is required. Associates or Bachelors degree in a technical field preferred.

    Previous experience in manufacturing, particularly in medical device, pharmaceutical, or similar regulated industries is highly desired. 1+ years of experience desired.

    * This salary range is an estimation made by beBee
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