Computer Systems Validation Lead

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    "location": {
      "city": "Rockville",
      "state": "Maryland",
      "postalCode": "20850",
      "addressCountry": "United States"
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    "datePosted": "2019-01-09",
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    "description": "<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. </span></p>\n<p><br></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Our Computer Systems Validation Leads work directly with our clients to support activities that include, but are not limited to, documentation review and approval, including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports. The individual will contribute directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel. Responsibilities include:</span></p>\n<p><br></p>\n<ul>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Optimization of CQV support process, including developing including developing standards and KPI reports.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Compile and analyze validation data and make recommendations for changes and/or improvements</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Maintain all documentation pertaining to computer systems validation</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Data integrity qualification<a rel=\"noopener noreferrer\"></a></span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Participate in cross-functional project teams including development &amp; deployment teams as well as customer Manufacturing, Engineering, Quality and other groups</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Some travel is required</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Skill level &amp; requirements:</span></p>\n<p><br></p>\n<ul>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Experience with IQ, OQ, PQ Final reports relating to Computer Systems Validation. </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Experience writing validation master plans. </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Experience with Configuration, design, data and traceability matrices. </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Validation experience with automated systems is preferred</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Strong knowledge of computerized system development life cycle approach is required</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Strong leadership skills and the ability to work in cross-functional team environments, as well as independently</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Experience coordinating Quality documentation, specifically qualification/Validation documentation</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Demonstrated excellent leadership/Project Manager skills</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Strong technical writing skills</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Excellent written and verbal communication skills</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Minimum Requirements:</span></p>\n<p><br></p>\n<ul>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Bachelor’s degree in a technical discipline (i.e. Engineering, Chemistry, Microbiology, Biology)</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">3 – 5 years Computer Systems Validation background </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">3 – 5 years IT Quality Assurance / Validation experience</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Current driver’s license and auto insurance or other means of independent transportation</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Quality Agents offers a full suite of benefits for full-time employees including:</span></p>\n<p><br></p>\n<ul>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Health, dental and vision insurance</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Life, AD&amp;D and Disability Insurance</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Health savings account for participants in our health plan</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">401k retirement plan</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Paid time off</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Paid holidays</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.</span></p>",
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