Senior Investigation Specialist

Job Summary

A company is looking for a Senior Investigation Specialist I.

Key Responsibilities

• Initiate, author, and finalize investigations and reports in the electronic quality management system (eQMS)
• Lead cross-functional meetings and manage multiple investigations while meeting timelines
• Utilize investigation techniques to interview participants and summarize investigation-related data

Required Qualifications

• BA/BS degree with 2 to 4 years of experience in the Biotech Industry or a Master's Degree with 0 to 2 years of experience
• Experience authoring moderately complex to complex investigations within the biotech industry
• Proficient in eQMS or other GMP electronic tools for authoring investigations
• Ability to work independently and manage multiple investigations simultaneously
• Understanding of sterile drug product manufacturing regulations is a plus