What are the responsibilities and job description for the Quality Compliance & Risk Analyst position at Katalyst Healthcares & Life Sciences?
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.
- 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.
