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Quality Assurance Specialist

2 months ago

Wichita, Kansas, United States Fagron Sterile Services Full time
Job Summary

We are seeking a highly detail-oriented Quality Assurance Batch Release Assistant to join our team at Fagron Sterile Services. As a key member of our quality team, you will be responsible for ensuring the accuracy and completeness of batch record documentation in a pharmaceutical manufacturing setting.

Key Responsibilities
  • Review and approve batch records in paper or electronic format to ensure compliance with FDA regulations and plant procedures.
  • Identify and communicate deviations from processes and initiate investigations as necessary.
  • Assist personnel in completing corrections on their own batches or on other reviewers' batches.
  • Disposition batches based on document review and investigation results.
  • Familiarize yourself with SOPs relevant to batch record review and processes being reviewed.
Requirements
  • 0-1 years of experience in a pharmaceutical manufacturing environment.
  • Ability to manage multiple tasks and adjust priorities based on supply needs.
  • Excellent communication and interpersonal skills to interact with multiple functional areas.
About Us

Fagron Sterile Services is a leading provider of pharmaceutical manufacturing services. We are committed to delivering high-quality products and services to our customers while maintaining the highest standards of quality and compliance.