Risk Management Associate II

Responsibilities

• Provide guidance and technical expertise on regulatory requirements and company risk management processes
• Assess risks associated with non-conformances, complaints, audits, and change controls
• Review and approve risk assessments submitted through investigations, complaints, audits, and change controls
• Author and approve risk assessments related to equipment, manufacturing process changes, and facility modifications
• Author and approve deviation reports related to product and process issues
• Lead and support risk management activities for engineering, manufacturing, and process improvement projects
• Serve as the site Subject Matter Expert (SME) for risk management
• Utilize statistical tools to evaluate and analyze risk and process data
• Perform annual reviews and updates of site process FMEAs
• Initiate, lead, and manage CAPAs and Change Control activities
• Participate in regulatory inspections and audits

Requirements

• Bachelor’s degree in science or engineering related field
• Minimum of 2 years pharmaceutical industry experience in parenteral manufacturing
• Proficiency in Microsoft Word, Excel, and Outlook
• Ability to use enterprise software such as JDE, Pilgrim, Veeva, or Trackwise

Preferred Qualifications

• American Society of Quality certification (e.g., CQE, CMQ/OE)
• Six Sigma certification

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.