Quality Assurance Associate

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    "description": "<p style=\"margin-left:0in;margin-right:0in;text-align:justify;\"><span style=\"font-size:9pt;\"><span style=\"font-size:10pt;\">The Quality Assurance Associate II is responsible for maintaining all training of a QAA I in addition to the review of controlled documents (both executed and unexecuted) in accordance with applicable SOPs. The QA Associate II will document review activities and status in the applicable Quality Systems. The purpose of QA review is to ensure the document, product, or process under assessment is compliant with all TRC, customer, and regulatory agency requirements. </span></span></p>\r\n\r\n<p style=\"margin-left:0in;margin-right:0in;\"><span style=\"font-size:10pt;\"><strong><span style=\"font-size:12pt;\">Responsibilities:</span></strong></span></p>\r\n\r\n<ul>\r\n\t<li><span style=\"font-size:10pt;\">Batch record review for completeness, accuracy, and compliance to TRC standards</span></li>\r\n\t<li><span style=\"font-size:10pt;\">Verification of critical processing steps (sterilization cycles, mix times, machine settings, etc.)</span></li>\r\n\t<li><span style=\"font-size:10pt;\">Track the number of corrections made in batch records</span></li>\r\n\t<li><span style=\"font-size:10pt;\">Issue product Certificate of Analysis or Conformance</span></li>\r\n\t<li><span style=\"font-size:10pt;\">Review of QMS documentation for compliance to SOPs, Work Instructions, and CGMP requirements</span>\r\n\t<ul style=\"list-style-type:circle;\">\r\n\t\t<li><span style=\"font-size:10pt;\">Manufacturing operations including supply chain, dispensing, compounding, filling, packaging, maintenance, and utilities</span></li>\r\n\t\t<li><span style=\"font-size:10pt;\">Quality operations including process control, quality control, quality assurance, compliance, and audit</span></li>\r\n\t\t<li><span style=\"font-size:10pt;\">Product labeling</span></li>\r\n\t</ul>\r\n\t</li>\r\n\t<li><span style=\"font-size:10pt;\">Track/trend the batch record review process- identify and initiate improvements to process</span></li>\r\n\t<li><span style=\"font-size:10pt;\">Perform Product Complaint batch record review</span></li>\r\n\t<li><span style=\"font-size:10pt;\">Maintain a professional team-oriented working relationship with fellow employees</span></li>\r\n\t<li><span style=\"font-size:10pt;\">Follow written and verbal procedures as directed by Supervisor</span></li>\r\n\t<li><span style=\"font-size:10pt;\">Follow TRC SOPs, safety and health guidelines and cGMP guidelines</span></li>\r\n</ul>\r\n\r\n<p style=\"margin-left:0in;margin-right:0in;\">&nbsp;</p>\r\n\r\n<p style=\"margin-left:0in;margin-right:0in;\">&nbsp;</p>\r\n\r\n<p>&nbsp;</p>\r\n",
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