• Quality Specialist I - Supplier Quality

    Job Locations US-CA-Seal Beach
    Job ID
    2018-1336
    Category
    Quality Control
  • Overview

    The Quality Specialist I, Supplier Quality is responsible for performing a wide variety of Supplier Quality activities to ensure compliance with applicable regulatory requirements.

    Responsibilities

    Responsibilities:

    • Assists with GMP internal and external audits
    • Assists with Supplier Quality training programs
    • Assists with Supplier Quality risk management
    • Assists with Supplier annual audit schedule
    • Performs batch records review for CMO raw materials
    • Perform release of CMO raw materials
    • Coordinates data and documentation review and analysis for suppliers
    • Processes deviations and non-conformances of raw materials
    • Coordinates supplier related change management
    • Authors documents, standard operating procedures and reports
    • Represents department in cross-functional teams, projects and supplier-related issue resolution

    Scope:

     

    • Uses professional concepts and company policies and procedures to solve a variety of problems
    • Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors
    • Exercises judgment within defined procedures and practices to determine appropriate action
    • Normally receives general instructions on routine work, detailed instructions on new assignments

    Qualifications

    Job Requirements:

     

    • Typically 1 year related experience in cGMP/FDA regulated industry
    • Bachelor’s degree in a scientific discipline or equivalent
    • Proficient in MS Office applications
    • Ability to gown aseptically for work in Clean Room environments

     

    Working Conditions and Physical Requirements:

    • Ability to sit or stand for extended periods of time 
    • Finger dexterity sufficient to use a computer and to complete paperwork activities
    • Vision sufficient to use a computer, to read written materials and to complete paperwork activities;
    • Hearing sufficient to communicate with individuals by telephone and in person
    • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
    • May be required to work alternate shifts
    • Ability to gown aseptically for work in Clean Room environments
    • Job performed in a lab, office, or utility (noisy) environment

     

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