What are the responsibilities and job description for the Quality Compliance & Risk Analyst position at Master Compliance?
Job Title : Quality Compliance & Risk Analyst
Location : Fully onsite in St. Louis
Start Date : ASAP
Job description :
We are looking for a Quality Compliance & Risk Analyst to lead risk identification, assessment, and mitigation efforts related to manufacturing processes, product quality, and regulatory compliance . This role will be responsible for ensuring adherence to industry regulations and implementing risk management strategies to enhance operational quality and compliance.
Key Responsibilities
- Perform risk assessments for manufacturing operations, product quality, and regulatory compliance.
- Identify, evaluate, and document potential quality risks and propose effective mitigation strategies.
- Utilize risk assessment methodologies such as FMEA, Risk Priority Number (RPN), and Fault Tree Analysis (FTA) .
- Ensure adherence to FDA, ISO 9001, GMP , and other industry compliance standards.
- Maintain and update risk assessment documentation to reflect compliance and process improvements .
- Collaborate with cross-functional teams to implement risk controls and best practices.
- Support continuous improvement initiatives by identifying risks and contributing to CAPA processes.
- Develop and deliver risk management training for internal teams.
- Prepare and present risk assessment findings to senior leadership and regulatory agencies .
Qualifications & Skills
