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Quality Assurance Investigator Specialist

2 months ago

Texas, United States Medix™ Full time

Position Overview: Medix™ is seeking a dedicated professional with extensive experience in deviation management and Corrective and Preventive Actions (CAPA) within a Good Manufacturing Practice (GxP) biotechnology environment. The ideal candidate will be responsible for conducting thorough investigations into process deviations, procedural anomalies, and nonconformance incidents.

Key Responsibilities:

  • Perform detailed investigations into process deviations, procedural anomalies, and nonconformance incidents.
  • Ensure comprehensive analysis of root causes, corrective actions, preventive actions (CAPA), and product impact during investigations. Formulate actionable recommendations based on established procedures and critical analysis.
  • Document the findings of investigations meticulously.
  • Design, implement, and oversee corrective action plans for identified exceptions, tracking their effectiveness.
  • Provide training and conduct assessments to ensure the integrity of quality systems and processes.
  • Manage projects to ensure timely completion in accordance with quality system requirements.
  • Assist during regulatory inspections or third-party audits.
  • Utilize trend analysis to inform scheduling and integrate findings into facility investigations.
  • Maintain and communicate accurate investigation timelines to management.
  • Deliver updates and notifications to management regarding investigation statuses.
  • Adhere to all organizational policies, Standard Operating Procedures (SOPs), and ensure compliance training is current.
  • Monitor Good Manufacturing Practice (GMP) and regulatory compliance activities critical for regulatory inspections.
  • Report GMP violations and deficiencies in quality systems to management, recommending product release holds until issues are resolved.

Qualifications:

  • A Bachelor’s Degree is mandatory.
  • A minimum of 2 years of experience in Quality Assurance, Manufacturing, Engineering, or related fields, or a combination thereof.
  • Experience with Trackwise is preferred.
  • Certifications such as Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) are advantageous.
  • Preferred experience in areas such as validation principles, pharmaceutical manufacturing processes, documentation systems, quality systems, and analytical or microbiological testing principles.