Quality Risk Assessment (QRA) Specialist

A Quality Risk Assessment (QRA) Specialist or Quality Risk Assessment Analyst plays a crucial role in evaluating, identifying, and mitigating risks associated with product quality, processes, and compliance. Here's a sample job description for a Quality Risk Assessment role:

Job Title: Quality Risk Assessment Specialist

Job Overview:

The Quality Risk Assessment Specialist is responsible for identifying, evaluating, and managing risks that could impact the quality of products or services. The individual will conduct assessments, collaborate with cross-functional teams, and implement risk management processes to ensure compliance with regulatory standards and company policies.

Key Responsibilities:

• Risk Identification & Evaluation: Identify quality risks related to manufacturing processes, product development, supply chain, and regulatory compliance. Evaluate the likelihood and severity of identified risks using risk assessment techniques (e.g., Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA)).
• Risk Mitigation: Develop and implement risk mitigation strategies to reduce or eliminate quality-related risks. Work with cross-functional teams to ensure action plans are executed and monitored.
• Risk Assessment Documentation: Document the results of risk assessments, including the identified risks, risk ratings, and mitigation strategies. Ensure proper record-keeping and documentation in compliance with industry standards and regulations (e.g., ISO, FDA, or GMP).
• Compliance & Standards: Ensure risk management practices comply with relevant quality management standards, regulations (such as FDA, ISO 9001, and GMP), and industry best practices.
• Continuous Improvement: Support continuous improvement initiatives by identifying areas for improvement based on risk analysis and trends. Facilitate corrective and preventive action (CAPA) processes when needed.
• Collaboration & Training: Work closely with various teams (e.g., R&D, operations, regulatory affairs) to ensure risks are properly identified and mitigated across the product lifecycle. Provide training to staff on risk management tools and techniques.
• Reporting: Prepare and present risk assessment findings, updates, and trends to senior management and regulatory bodies as required.

Qualifications & Skills:

• Education: Bachelor s degree in a relevant field (e.g., Bio-Engineering, Life Sciences, Pharmaceutical Sciences, or Quality Management). Advanced certifications in Quality Management (e.g., Six Sigma, ASQ Certified Quality Engineer (CQE)) are a plus.
• Experience: 2-5 years of experience in a quality assurance or risk management role, preferably in a regulated industry (e.g., pharmaceuticals, medical devices, food safety, manufacturing).
• Skills:
• Strong analytical and problem-solving skills.
• Familiarity with risk assessment tools (e.g., FMEA, Risk Priority Number (RPN), Fault Tree Analysis).
• Proficient in quality management systems (QMS) and regulatory frameworks.
• Excellent communication skills (both written and verbal).
• Ability to work cross-functionally and independently.
• Strong organizational skills and attention to detail.

Preferred Qualifications:

• Experience with regulatory audits and inspections (e.g., FDA, ISO 13485).
• Knowledge of statistical process control (SPC) and data analysis tools.
• Proficiency with risk management software (e.g., windchill, TrackWise).

Other notes

• Location Bridgeton, MO Fully onsite need locals or someone from nearby states and relocate
• Prefer microbiology background
• Exp of 5-10 years writing quality risk assessments
• Exp of tracking the assessments through entire process
• Manufacturing experience
• Rate is open