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Quality Assurance Associate

Quality Assurance Associate

Wheeler Bio, Inc.Oklahoma City, OK, US
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Job Description

Job Description

Job Description

Job Title : QA Associate

Department : Quality Assurance

Reports To : QA Operations Manager

Position Overview

Reporting to the QA Operations Manager, the QA Associate primarily supports document management, deviation investigations, CAPA implementation, QA on-the-floor support, and quality data review.

Key Responsibilities

  • Coordinate and maintain the document control system.
  • Review, approve, and archive controlled documents (SOPs, batch records, etc.).
  • Investigate deviations, determine root causes, and propose CAPAs.
  • Monitor and track CAPA progress and effectiveness.
  • Assist with internal and external quality audits.
  • Ensure compliance with cGMP and other regulatory requirements.
  • Provide training on QA processes and on-the-floor support.
  • Identify and support process improvements for QA function.

Qualifications

  • Bachelor's degree in a relevant scientific field or equivalent experience.
  • Minimum of 2 years of quality assurance experience in biotech / pharma industry.
  • Experience in document management, investigations, and CAPA processes.
  • Familiarity with cGMP and other relevant quality standards.
  • Excellent communication and organizational skills.
  • Additional Information

  • Compensation commensurate with experience.
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    Quality Assurance Associate • Oklahoma City, OK, US