Quality Assurance Specialist

3 weeks ago


Austin, Texas, United States PSC Biotech Full time
Job Overview

PSC Biotech, a leading provider of life sciences services, is seeking an experienced Quality Assurance Investigator to join their team. This is a 3-6 month temporary position with potential extension.

Key Responsibilities
  • Conduct thorough investigations into quality incidents, deviations, and non-conformances, ensuring all findings are accurately documented.
  • Identify root causes and implement recommendations for improvement, analyzing trends and data to prevent reoccurrence.
  • Collaborate with cross-functional teams to gather necessary information and data.
  • Develop and implement effective CAPAs based on investigation findings, monitoring their effectiveness and making adjustments as needed.
  • Generate and maintain accurate documentation in accordance with Good Manufacturing Practices (GMP), including incident reports, root cause analyses, and corrective actions.
  • Provide internal and external audit support as required.
Requirements
  • Bachelor's degree in a related engineering, manufacturing, or scientific discipline.
  • 2-5 years of experience in a quality role within the pharmaceutical manufacturing industry.
  • Strong understanding of cGMP and industry regulations/quality requirements.
  • Excellent technical writing skills and ability to generate, review, and approve quality documentation.
  • Experience documenting and reporting investigation findings.
  • Strong attention to detail and commitment to quality.
  • Advanced analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.

The estimated salary for this position is between $80,000 and $110,000 per year, depending on experience and qualifications.



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