Quality Associate I

US-GA-Union City
Job ID
2017-1069
Category
Quality Control

Overview

 Performs a wide variety of QA activities to ensure compliance with applicable regulatory requirements

Responsibilities

  • 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.

Qualifications

  • 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.

 

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