<p>Summary: The position entails management of Quality Assurance staff and daily Quality Assurance functions supporting Clinical Systems, Inc. contract label generation operations. Also, any additional tasks needed to assist Clinical Systems, Inc. with day-to-day operations. This position reports directly to the General Manager.</p> <p>Requirements:</p> <ul> <li>College degree. </li><li>Ability to proof read printed material and check written documentation. </li><li>Ability to follow detailed verbal and written instructions. </li><li>Full knowledge of cGMP regulations and operational SOPs. </li><li>Advanced mathematical skills and grammatical knowledge. </li><li>Advanced computer skills. </li><li>Excellent analytical skills. </li><li>Excellent organizational skills. </li><li>Excellent communications skills. </li></ul> <p>Responsibilities:</p> <ul> <li>Prepare and implement operational SOPs. </li><li>Maintain and update documents related to operations. </li><li>Overall control of operational procedures. </li><li>Preparation and conducting cGMP and SOP training sessions. </li><li>Enforce proper cGMP practices and full adherence to SOP requirements related to operations. </li><li>Review documents and determine disposition of all products. </li><li>Conduct/handle internal, vendor, and customer audits. </li></ul> <p>Training:</p> <ul> <li>cGMP training </li><li>SOP training </li><li>On the job training </li><li>Prior experience </li></ul> <p>Working Conditions: CCL Clinical Systems, Inc. will provide a clean and safe work environment for all employees.</p>