Senior QA Validation Associate

BioMarin is seeking a Senior QA Validation Associate to support the quality oversight of validation activities in a GMP regulated environment. The role is responsible for maintaining current knowledge of industry standards and regulatory requirements, supporting the QA Validation group in maintaining regulatory compliance, and providing mentorship and SME support to more junior members of the QA Validation team.

Requirements

• Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences)
• +5 years’ experience in a cGMP regulated manufacturing environment
• Ability to speak, present data, and defend approaches in front of audiences and inspectors
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations

Benefits

• Life insurance
• Disability insurance
• 401(k) program
• Stock purchase plan