Quality Assurance Investigator

5 days ago

Austin, Texas, United States PSC Biotech Full time
About PSC Biotech

PSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the pharmaceutical manufacturing industry.

Job Summary

We are seeking an experienced QA Investigator to join our team. This is a W2 temp 36-month position with potential extension.

Key Responsibilities
  • Conduct thorough investigations into quality incidents, deviations, and nonconformances, ensuring all investigations are properly documented.
  • Identify root causes, analyze trends, and data to prevent reoccurrence.
  • Develop and implement effective CAPAs based on investigation findings, monitor their effectiveness, and make adjustments as needed.
  • Collaborate with cross-functional teams to gather necessary information and data.
  • Generate and maintain accurate and up-to-date documentation in accordance with Good Manufacturing Practices (GMP).
  • Provide internal and external audit support as needed.
  • Ensure production and project schedules are on track.
  • Continuously monitor manufacturing processes, activities, and systems to ensure compliance with industry regulations, cGMPs, and internal standard operating procedures.
Requirements
  • Bachelor's degree in a related engineering, manufacturing, or scientific discipline.
  • 25 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 understanding of quality documentation to generate, review, and approve required documentation.
  • Experienced in documenting and reporting investigation findings.
  • Strong attention to detail and commitment to quality.
  • Advanced analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. We prohibit discrimination against qualified employees, interns, and applicants in all aspects of employment, including recruitment, interviewing, hiring, evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination, and employer-sponsored activities and programs.

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