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Regulatory Compliance Analyst

2 months ago

College Station, Texas, United States Azzur Group Full time

At Azzur Group, we are dedicated to providing comprehensive life-cycle solutions for the life science sector, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards. Our facilities, including Azzur Cleanrooms on DemandTM, labs, training centers, and consulting offices, support organizations in their growth journey. With nearly four decades of experience, we are a trusted partner for leading pharmaceutical, biotechnology, medical device, and healthcare companies.

The Regulatory Compliance Analyst plays a crucial role in investigating compliance issues and drafting exception documentation. This position involves coordinating quality system programs and projects to uphold regulatory standards. The Analyst will oversee, develop, and manage investigations in accordance with established procedures. Additionally, the Analyst will ensure that all documentation effectively addresses root causes, corrective actions, preventive measures, and product impacts.

Key Responsibilities:

  • Conduct thorough investigations into process deviations, procedural exceptions, and nonconformities.
  • Ensure comprehensive analysis of root causes, corrective actions, preventive actions (CAPA), and product impacts during investigations.
  • Document findings from investigations accurately.
  • Develop, implement, and monitor corrective action plans for exceptions.
  • Provide training and conduct assessments to maintain quality systems and processes.
  • Manage projects to ensure timely completion in line with quality system requirements.
  • Support activities during regulatory or third-party audits.
  • Utilize trend data to inform and enhance facility investigations.
  • Maintain and communicate accurate investigation schedules to management.
  • Deliver timely notifications to management regarding compliance issues.
  • Adhere to company policies, standard operating procedures (SOPs), and ensure compliance training is current.
  • Monitor GMP and regulatory compliance activities critical for inspections.
  • Communicate any GMP violations and quality system deficiencies to management, recommending product release holds until issues are resolved.
Required Knowledge, Skills & Qualifications:
  • Proficient understanding of Good Manufacturing Practices and regulatory requirements.
  • Strong communication and organizational abilities.
  • Capability to engage with all levels of management effectively.
  • Excellent technical writing skills for documenting investigation outcomes.
  • Problem-solving skills focused on both personnel and processes.
  • Ability to foster a collaborative environment for problem-solving, promoting trust and open communication.
  • Technical expertise to identify and address potential compliance issues.
Education and Experience:
  • Bachelor's Degree is mandatory.
  • A minimum of 4 years of experience in Quality, Manufacturing, Engineering, or related fields.
  • Experience with Trackwise is essential.
  • Certifications such as CQA or CQE are preferred.
  • Experience in validation principles, pharmaceutical manufacturing methods, documentation systems, quality systems, and analytical or microbiological testing principles is advantageous.
  • Project management and quality engineering experience is preferred.