Minimum of Bachelor's Degree in Science, or related. Minimum of 4 to 6 years' experience in a Pharmaceutical Manufacturing facility working in operations, production, or quality, and a minimum of 2 - 3 years' experience in investigation writing in the Pharmaceutical industry.

Key Skills:
• Knowledge and understanding of Pharmaceutical GxPs and excellent cGMP documentation skills
• Experience authoring investigations for manufacturing, process, and laboratory out of specification.
• Prepare product complaint investigations
• Ability to conduct in-depth interviews and gather pertinent information to drive to root cause conclusions, product impact analyses and initiations of CAPA actions, if required
• Exceptional writing and communication skills to clearly convey investigational findings
• Advanced MS office skills including Word
• Well organized and detail oriented with the ability to handle multiple tasks