Quality Assurance Specialist

  • Ashtabula
  • Astrix
Our client is a leading global chemical group, specializing in performance additives and solutions for water treatment & lubricants, oil & gas and plastics, flame retardants and boasts a wide product range able to fulfil the requirements of the most demanding applications, including personal care.<br><br>Located in Ashtabula, OH<br><br><strong>Schedule</strong>: M-F 1st shift (8a-4:30p), Hybrid (3 days in/2 days out of office)<br><br><strong>Pay</strong>: $65k-$75k<br><br><strong>Type</strong>: Direct Hire<br><br>The Quality Assurance Specialist is responsible for supporting the quality system processes and for maintaining quality assurance standards, processes, and controls.<br><br><strong>Requirements:</strong><br><ul><li>Bachelors' degree in a scientific discipline or equivalent experience.</li><li>At least 2 years' experience in cGMP/FDA environment (preferred).</li><li>Strong background in ISO 9001-2015, ISO 14001-2015, cGMP, CFR 210/211, FDA, Pharmaceutical, HACCP, Food Safety Management and ICHQ7 requirements.</li><li>Experience in a manufacturing environment, with a strong preference towards chemical manufacturing/processing.</li></ul><br><strong>Responsibilities:</strong><br><ul><li>The generation, review, facilitation of corrections, and archival of documents used to support GMP manufacture of Final Product.</li><li>Perform internal and external audits as assigned.</li><li>Review and release raw materials, intermediate products and finished products. Assist in incoming material and tote inspection.</li><li>Perform review and approval of OOS, deviations, nonconformance, and investigation as required.</li><li>Coordinate CAPA, OOS, deviations, nonconformance, and investigations.</li><li>Ensure systems are following current SOPs.</li><li>Assist investigations and resolve potential product quality issues to improve efficiency.</li><li>Assist with writing, revising, and approving standard operating procedures and work</li><li>instructions.</li><li>Review and approve SOP, protocols and reports as necessary.</li><li>Coordinate and/or conduct GMP training and SOP training.</li><li>Generate, publish, and manage quality systems metrics to drive continuous improvement.</li></ul>