Quality Assurance Manager

Job Summary

A company is looking for a Manager, Quality Assurance.

Key Responsibilities

• Manage lot release activities and review manufacturing batch records from contract manufacturing organizations (CMOs)
• Ensure compliance with approved specifications by reviewing analytical data and test results
• Communicate manufacturing deficiencies and represent QA on internal and external project teams and audits

Required Qualifications

• Bachelor's degree with 10+ years of relevant Quality Assurance experience
• Prior quality control/analytical chemistry experience
• Knowledge of ICH, FDA, and Good Documentation Practice principles
• Ability to engage in cross-functional interactions with internal and external staff
• Willingness to travel as needed