Regulatory Compliance Analyst

1 week ago

Texas, United States Barrington James Full time

Join Our Team as a Regulatory Compliance Analyst

Contract Opportunity - Full-Time - On-Site - Possibility for Extension.

The Regulatory Compliance Analyst plays a crucial role in addressing compliance challenges, drafting exception reports, and managing quality assurance initiatives to uphold regulatory standards. This position requires oversight of investigations, identification of root causes, and the execution of corrective and preventive measures.

Core Responsibilities:

  • Examine deviations from established processes, procedural irregularities, and nonconformance incidents.
  • Conduct comprehensive investigations into root causes, corrective actions, preventive measures (CAPA), and assess product implications.
  • Analyze and propose actions based on procedural guidelines and analytical reasoning.
  • Accurately document findings from investigations.
  • Design, implement, and evaluate the success of corrective action strategies.
  • Facilitate training sessions and perform evaluations to uphold quality systems.
  • Oversee projects to ensure adherence to quality system timelines.
  • Assist in regulatory and external audit processes.
  • Leverage trend analysis to plan and integrate facility investigations.
  • Maintain and relay investigation timelines to leadership.
  • Provide necessary updates to management as needed.
  • Comply with organizational policies and ensure ongoing compliance training.
  • Monitor Good Manufacturing Practices (GMP) and regulatory compliance efforts.
  • Report GMP infractions and quality system shortcomings to management, advising on product holds until issues are resolved.
  • Required Knowledge, Skills & Qualifications:

Education and Experience:

  • Familiarity with Good Manufacturing Practices and regulatory standards.
  • Bachelor's Degree is mandatory.
  • A minimum of 4 years' experience in Quality Assurance, Manufacturing, Engineering, or related fields.
  • Experience with Trackwise is advantageous.
  • CQA or CQE certification is preferred.
  • Experience in Validation principles, Pharmaceutical manufacturing processes, Documentation systems, Quality Systems, and analytical or microbiological testing is desirable.
  • Project management and quality engineering experience is a plus.

If you are interested in this opportunity, please submit your application.

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