Quality Assurance Specialist

<ul><li>Conduct batch record reviews and manage the release process</li><li>Review completed or executed batch records and follow up on errors</li><li>Attach supportive materials to the completed records</li><li>Create and maintain error logs</li><li>Review and validate completed raw material inventory cards</li><li>Draft quality assurance procedures (such as SOPs) and provide support in driving the improvement programs in the Quality Assurance Team</li><li>Review and approve of SOP's; provided consultation in development of new SOP's to ensure product development conforms with GXPs</li><li>Review investigations and provide support in implementation of CAPAs as needed </li><li>Review change control and ensure proper assessment is performed and action plan is documented to implement the change control </li><li>Handle certificate of analysis and certificates of compliance</li><li>Other duties as assigned</li></ul><br><strong>QUALIFICATIONS</strong><br><ul><li>4 years experience working within QA</li><li>Prior experience working with a CMO preferred</li><li>Bachelors Degree</li></ul>