QA Lead Auditor – With Previous FDA Audit Experience. 
This position will be responsible for planning and conducting audit procedures, including identifying and defining audit issues, developing audit criteria, reviewing and analyzing evidence, documenting the status and operating procedures of the organization, and preparing audit reports. The Lead Auditor will be responsible for the assessment of the organization’s quality system and compliance status in accordance with all relevant regulations and guidelines, such as 21CFR Parts 211, Parts 600s, Parts 3 &4, as well as Part 820. The lead auditor will independently perform quality audits of drug product manufacturing practices to ensure products, controls, procedures, and processes meet quality standards. The Lead Auditor will also prepare audit reports and communicate findings to stakeholders.

Responsibilities:

·       Able to perform high-profile audits for manufacturing facilities and clinical trial si...