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Quality Assurance Investigator

2 months ago

College Station, Texas, United States Medix™ Full time

Position: Deviation Investigator

Key Responsibilities:

  • Conduct thorough investigations into process deviations, procedural anomalies, and nonconformance incidents.
  • Ensure comprehensive analysis of root causes, corrective actions, and preventive measures (CAPA), along with assessment of product impact.
  • Compile and document findings from investigations.
  • Design, implement, and oversee corrective action plans for identified exceptions.
  • Facilitate training sessions and perform verification assessments to maintain 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.
  • Leverage trend analysis to inform scheduling and enhance facility investigations.
  • Maintain and communicate accurate investigation timelines to management.
  • Provide updates and notifications to management regarding investigation outcomes.
  • Adhere to all organizational policies, standard operating procedures (SOPs), and ensure compliance training is current.
  • Monitor Good Manufacturing Practices (GMP) and regulatory compliance, particularly during inspections.
  • Report GMP violations and deficiencies in quality systems to management, recommending product release holds until issues are resolved.

Knowledge, Skills & Qualifications:

  • Proficient understanding of Good Manufacturing Practices and relevant regulatory standards.
  • Excellent communication and organizational abilities.
  • Capability to engage with all levels of management effectively.
  • Strong technical writing skills for documenting investigation results.
  • Proficient in problem-solving, focusing on both personnel and processes.
  • Ability to cultivate a collaborative environment for addressing complex issues during investigations and follow-ups.
  • Utilize technical expertise to identify and comprehend potential serious compliance challenges.

Education and Experience:

  • A Bachelor's Degree is mandatory.
  • A minimum of 2 years of experience in Quality Assurance, Manufacturing, Engineering, or related fields.
  • Experience with Trackwise is essential.
  • Certification as a Quality Auditor (CQA) or Quality Engineer (CQE) is preferred.
  • Desirable experience in areas such as validation principles, pharmaceutical manufacturing techniques, documentation systems, quality systems, and analytical or microbiological testing methodologies.
  • Experience in project management and quality engineering principles is advantageous.