Quality Compliance Investigator

2 weeks ago

College Station, Texas, United States Medix™ Full time

Position: Deviation Investigator

Key Responsibilities:

  • Perform thorough investigations into process deviations, procedural anomalies, and nonconforming incidents.
  • Ensure comprehensive analysis of root causes, corrective actions, and preventative measures (CAPA), along with assessing product impact during investigations.
  • Compile and document findings from investigations in a clear and concise manner.
  • Design, execute, and oversee corrective action plans for identified exceptions, monitoring their effectiveness.
  • Deliver training sessions and conduct verification assessments to uphold the integrity of quality systems and processes.
  • Manage project timelines to ensure adherence to quality system requirements.
  • Support activities during regulatory inspections or third-party audits.
  • Leverage trend analysis to inform scheduling and integrate findings into facility investigations.
  • Maintain and communicate accurate investigation timelines to management.
  • Provide timely notifications to management regarding investigation outcomes.
  • Comply with all company policies, standard operating procedures (SOPs), and ensure that compliance training is current.
  • Oversee Good Manufacturing Practices (GMP) and regulatory compliance activities, particularly during inspections.
  • Report GMP violations and deficiencies in quality systems to management, recommending product release holds until issues are resolved.

Required Knowledge, Skills & Qualifications:

  • In-depth understanding of Good Manufacturing Practices and regulatory standards.
  • Exceptional communication and organizational abilities.
  • Capability to engage with all management levels 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 that encourages open communication and trust during investigations and follow-ups.
  • Technical expertise to identify and comprehend potential serious compliance issues.

Education and Experience:

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

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