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
- Bachelor’s degree in Engineering, Life Sciences, Quality Management, or related fields.
- 2-5 years of experience in quality risk assessment, compliance, or regulatory roles in a regulated industry.
- Expertise in risk management tools such as FMEA, RPN, and FTA.
- Strong knowledge of Quality Management Systems (QMS) and industry regulations.
- Experience in regulatory audits, compliance assessments, and CAPA implementation.
- Strong analytical, communication, and problem-solving skills.
- Ability to work independently and collaboratively across multiple teams.
- Familiarity with risk management software (e.g., Windchill, TrackWise) is a plus.
