Quality Specialist
: Job Details :

Quality Specialist - Decatur IL - The QA Specialist will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas are in compliance, and will train on and gain competency in activities as they relate to quality and adherence to various standards. Specific responsibilities include but are not limited to the following:Review new or revised Standard Operating Procedures (SOPs) and forms for compliance with applicable regulations. Assist other departments in the development, revision, and preparation of SOPs and forms in accordance with policies, regulations and protocols. Owns and updates site level cGMP documentation. Performs audit preparation activities and assists with hosting audits. Identifies root cause and CAPAs associated with audit findings and manages communications with auditing bodies. Work with internal and external auditors; may be required to act as spokesperson on behalf of company. Participate in customer complaint inves...Specialist, Quality, Manufacturing, Technology, Reports, Skills, Audit