Dendreon Corporation Quality Specialist I in Union City, Georgia

The Quality Specialist I performs a wide variety of QA activities to ensure compliance with applicable regulatory requirements.

  • Assists with GMP internal and external audits.

  • Assists with training programs.

  • Performs batch records review.

  • Perform disposition of product.

  • Coordinates data and documentation review and analysis.

  • Processes deviations and non-conformances.

  • Writes documents, standard operating procedures and reports.

  • Represents department in cross-functional teams, projects and GXP-related problem 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.

  • 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.

ID: 2018-1195

External Company Name: Dendreon Corporation

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