Risk Management Associate

Virtue America; United States; On-site; USD 55,000 - 75,000; Full time

Job summary

Virtue America seeks an Entry-Level Risk Management Associate to support risk assessment, risk analysis, and quality compliance in a pharmaceutical/biotech/life-sciences setting. Recent graduates with relevant majors are encouraged to apply.

Responsibilities include identifying and documenting risks, maintaining risk management files, participating in FMEA, CAPA, and change control, and ensuring compliance with GMP/cGMP and FDA regulations.

Qualifications

• Bachelor's degree in Biomedical Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry or Life Sciences.
• 0–2 years in risk management, quality assurance, regulatory affairs, or pharma/medical device ops.
• Familiarity with GMP/cGMP and FDA regulations; strong documentation skills.

Responsibilities

• Identify, assess, document, and monitor operational, product, and process risks.
• Support preparation and maintenance of risk management plans, assessments and reports.
• Participate in FMEA and risk evaluation activities.
• Identify potential failure modes, hazards and mitigation strategies.
• Maintain risk management files and associated quality documentation.
• Support risk reviews related to manufacturing processes, equipment, products, and lab operations.
• Collaborate with QA, Regulatory Affairs, Engineering, Manufacturing and Validation teams.
• Assist with CAPA, deviations, nonconformance investigations and change control.
• Track risk mitigation actions and follow up on effectiveness.
• Ensure risk documentation complies with GMP/cGMP, SOPs and GDP.
• Support internal audits, regulatory inspections, and continuous improvement initiatives.
• Prepare risk assessment summaries, reports and compliance trackers.

Skills

Biomedical Engineering

Biotechnology

Pharmaceutical Sciences

Chemistry

Biology

Documentation

Analytical skills

Education

Bachelor's degree in Biomedical Engineering

Tools

Microsoft Word

Microsoft Excel

Job description

We are seeking an Entry-Level Risk Management Associate to support risk assessment, risk analysis, and quality compliance activities within a pharmaceutical, biotechnology, or medical device environment. The ideal candidate will assist with identifying potential risks, maintaining risk management documentation, supporting mitigation activities, and ensuring compliance with applicable FDA regulations and quality standards.

This opportunity is suitable for recent graduates with a background in Biomedical Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, Chemistry, or a related field who are interested in quality, regulatory compliance, and risk management.

Key Responsibilities

• Assist with identifying, assessing, documenting, and monitoring operational, product, and process-related risks.
• Support preparation and maintenance of risk management plans, assessments, and reports.
• Participate in Failure Mode and Effects Analysis (FMEA) and risk evaluation activities.
• Assist with identifying potential failure modes, hazards, and risk mitigation strategies.
• Maintain risk management files and associated quality documentation.
• Support risk reviews related to manufacturing processes, equipment, products, and laboratory operations.
• Collaborate with Quality Assurance, Regulatory Affairs, Engineering, Manufacturing, and Validation teams.
• Assist with CAPA, deviations, nonconformance investigations, and change control activities.
• Track risk mitigation actions and follow up on their implementation and effectiveness.
• Ensure risk documentation complies with GMP/cGMP, SOPs, and Good Documentation Practices (GDP).
• Support internal audits, regulatory inspections, and continuous improvement initiatives.
• Prepare risk assessment summaries, reports, and compliance trackers.

Required Qualifications

• Bachelor's degree in Biomedical Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, Mechanical Engineering, or a related field.
• 0–2 years of experience in risk management, quality assurance, regulatory affairs, or pharmaceutical/medical device operations.
• Recent graduates and candidates with relevant internships or academic projects are encouraged to apply.
• Basic understanding of risk assessment, risk analysis, and quality management principles.
• Familiarity with GMP/cGMP, FDA regulations, and quality documentation.
• Strong analytical, organizational, documentation, and problem-solving skills.
• Proficiency in Microsoft Word and Excel.