Quality Assurance Specialist

4 days ago

Texas, United States Evestra, Inc. Full time
Job Title: Quality Assurance Specialist

Evestra, Inc. is a leading biopharmaceutical company dedicated to developing and commercializing innovative women's healthcare products. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities:
  • Perform and document GLP, cGMP, and internal audits to ensure compliance with regulations.
  • Prepare audit reports and follow up to obtain resolutions that meet regulatory requirements.
  • Identify and address quality issues within the organization.
  • Lead product nonconformance investigations and prepare impact assessments for process deviations.
  • Research and interpret regulations relevant to our operations.
  • Maintain auditing schedules and participate in vendor certification programs.
  • Manage quality assurance databases, reports, and files.
  • Assist in auditing external raw material vendors, contractors, and collaborators.
  • Develop and deliver personnel training to ensure understanding of QA systems.
  • Review batch production records and ensure compliance with documentation requirements.
  • Assist in reviewing supporting documentation, including area and equipment log books, cleaning logs, and environmental monitoring data.
  • Verify product release status and complete release checklists and certifications.
  • Monitor and review validation projects.
  • Support management reports, area clearances, and analysis of quality-indicating data trends.
Requirements:
  • Bachelor's degree in chemistry, biology, or equivalent.
  • Two to four years of related experience or equivalent.
  • Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, GMPs, and product/process validation.
  • Excellent written and oral communication skills.
  • Strong organizational, problem-solving, and analytical skills.
  • Ability to manage priorities and workflow.
  • Commitment to excellence and high standards.

Evestra, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.

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