Document Control Specialist

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    "description": "<p style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\"><strong>Position Summary:&nbsp; </strong>Plans and conducts activities associated with the quality assurance and compliance of Cosmetic, Drug and Medical Device processes, materials, systems and products by performing duties related to initiation, approval and closure of Change Management and Quality Records. This Document Control Specialist will ensure his/her activities maintain<span style=\"background-color:#FFFFFF;\"><span style=\"color:#000000;\"> compliance with FDA, international/global regulations, and the ISO 13485:2016 standard as related to document control, change management, training and batch record review/disposition activities.</span></span></span></span></p>\r\n\r\n<p style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\"><strong>Essential Duties and Responsibilities: </strong></span></span></p>\r\n\r\n<ul>\r\n\t<li style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\">Ensure that QA functions are compliant with all required GMP regulations.</span></span></li>\r\n\t<li style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\">Assist in the conduct of internal and external audits as necessary.</span></span></li>\r\n\t<li style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\">Scan and file all training records, change management records and batch records as required.</span></span></li>\r\n\t<li style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\">Assist the Document Control and Quality management with the biannual review of SOPs, uniPoint reconciliation/verification, vendor change control and customer changes as required.</span></span></li>\r\n\t<li style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\">Assist Document Control management with the monitoring and maintaining of the site document control system including creation, revision, and approval SOPs as required as well as monitoring of metrics, performance indicators related to change management.</span></span></li>\r\n\t<li style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\">Maintain and improve the level of GMP compliance and stay abreast of industry and regulatory compliance trends and requirements.</span></span></li>\r\n\t<li style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\">Ensure that all operations are performed in accordance with SOP&rsquo;s, FDA and GMP guidelines.</span></span></li>\r\n</ul>\r\n\r\n<ul>\r\n\t<li style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\">Receive and analyze appropriate test results for the release of final product materials.</span></span></li>\r\n\t<li style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\">Review and audit completed batch records, change controls, change requests, DCN records, SOP binders to verify compliance to governing procedures and regulations.</span></span></li>\r\n\t<li style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\">Scan completed batch records into Laserfiche. Upload records into uniPoint. Complete tasks in uniPoint.</span></span></li>\r\n\t<li style=\"text-align:justify;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\">Follow up with personnel on CAPA and NCR reports as well as any change related to deliverable, training records, uniPoint or Laserfiche tasks.</span></span></li>\r\n</ul>\r\n",
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