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Job Details

Quality Specialist I - Supplier Quality

Seal Beach, CA

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US-CA-Seal Beach

Job ID 2018-1336
Category Quality Control


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



  • 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


  • 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


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

Dendreon is an EEO/AA employer M/F/D/V.****

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