<p>Summary:</p> <p>Position will monitor and maintain cGMP, FDA, State and Federal regulatory compliance procedures, provide cGMP training, and manage customer complaints to ensure compliance across all regulated processes.</p> <p>Responsibilities:</p> <ul> <li>Change order/change control assessments for cGMP documents. </li><li>Initiate, review, track, and close investigations (SIRs, LIs, CAPAs, and SCARs). </li><li>Complete monthly and bi-annual quality metrics reports. Complete quarterly reports and year-end inventory for controlled substances. </li><li>Perform Annual Product Reviews to include collecting data, authoring report, and drawing conclusions based upon the data collected on the continued validated state of the product. </li><li>Review, write, and/or revise company SOPs as required to assure that procedures remain current </li><li>Manage cGMP training program and electronic document management system. </li><li>Manage customer complaint system. Log complaints, investigations, and close complaints, communicate with third party partner, review and approve reports. </li><li>Review temperature and humidity reports for each stability chamber monthly and for the annual report. Review, sign off, and maintain the records of the QC water testing results. </li><li>All other duties may be assigned. </li></ul> <p>Qualifications & Requirements:</p> <ul> <li>Bachelors Degree in a science related field. </li><li>3 years of experience in Quality Assurance or Quality Control in a government regulated environment. </li><li>Travel up to 0% of time. </li></ul>