Quality Assurance Specialist

Job Summary

A company is looking for a Specialist in Technical Training and Quality Assurance.

Key Responsibilities

• Write, revise, and review equipment and process validation plans, ensuring compliance with regulatory guidelines
• Prepare training materials and maintain training records for new and existing staff, ensuring timely completion of training documentation
• Conduct audits of laboratory and computer processes, perform root cause analysis, and manage corrective actions for quality assurance

Required Qualifications

• High School Diploma or GED required; Associate's or Bachelor's degree preferred
• 7+ years of experience in a GMP environment with a High School diploma, or 5+ years with an Associate's degree, or 1+ year with a Bachelor's degree
• Demonstrated ability to train staff effectively
• Basic understanding of current Good Manufacturing Practices (cGMP)
• Ability to work independently and manage competing priorities