Project Manager

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  "location": {
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    "city": "Various",
    "region": null,
    "country": "United States",
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    "confidence": 0.95
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    "countries": [
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{}

{
  "list_job": {
    "id": "5",
    "isRemote": null,
    "location": {
      "city": "Various",
      "state": "Maryland"
    },
    "atsLocation": {
      "city": null,
      "state": null,
      "country": null,
      "province": null
    },
    "departmentId": "18505",
    "locationType": "0",
    "jobOpeningName": "Project Manager",
    "departmentLabel": "Validation",
    "employmentStatusLabel": "Full-Time"
  },
  "detail_errors": [],
  "detail_job_opening": {
    "location": {
      "city": "Various",
      "state": "Maryland",
      "postalCode": "x",
      "addressCountry": "United States"
    },
    "datePosted": "2018-10-11",
    "atsLocation": {
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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 Project Managers will oversee the qualification and requalification of equipment used to manufacture and test biologics, drug products, etc. at client sites.  The Project Manager will evaluate the equipment, utilities, systems and procedures used in development, production, and holding of pharmaceutical products and determine a validation approach.  The individual should have experience with current US and international regulations, guidance, industry best practice in one of the following areas of validation: facilities, utilities, and equipment qualifications, process validation, analytical method validation, or cleaning validation.  The individual will coordinate validation activities with the client and meet timelines. The Project Manager is also responsible for client relations at the job site, including but not limited to on-going assessment of current client needs in order to offer solutions and services to the client and will seek and solicit prospective clients as well.  </span></p>\n<p><br></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">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;\">Write validation master plans related to specific projects and coordinate project meetings related to execution of the validation master plan. Write validation site specific and multi-site procedures. Support implementation of validated systems change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies and manufacturing documentation review and approval.  Available to travel nationally and internationally. </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Present Quality Agents service offerings to prospective clients</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Constantly seek new client opportunities </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Participate in the integration, installation, testing, validation and deployment of new applications and systems</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Write, review, and/or execute validation plans, IQ/OQ/PQ protocols and SOPs for equipment</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Serve as system administrator with responsibility for user account maintenance</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Troubleshoot and resolve equipment issues at various client sites</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Drive communication with clients and serve as primary point of contact for cleaning, manufacturing and validation issues</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Perform risk assessments to determine criticality and impact of user reported issues</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Participate in sponsor and regulatory audits.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Maintains up-to-date knowledge of validation requirements, practices and procedures. </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Participate as lead for facilities upgrades and major construction projects</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Cleaning validation and verification</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Sterility validation, medial fill</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Process Validation of biological process</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Filter and method validation</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 and Requirements:</span></p>\n<p><br></p>\n<ul>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Able to problem solve and troubleshoot.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Understand existing and new business processes and requirements to ensure proper implementation and validation of systems</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Thorough knowledge of 21 CFR Part 11, Annex 11, GAMP5, 21 CFR Part 58 and industry best practices.</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;\">Proficient in Microsoft Word, Excel, Power point, and Project</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Proficiency with validation equipment such as the Kaye validator, wireless data loggers, or other monitoring devices is strongly desired. </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Able to read P&amp;ID, Isometric and \"As Built\" drawings. </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Experience performing IQ/OQ on large automated systems/process equipment and the computerized system lifecycle associated with it</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">FAT experience with large automated systems</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Experience using statistical tools is a plus to analyze data captured during validation studies.</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;\">BS in a technical discipline (Engineering, chemistry, microbiology, biology) or equivalent work experience </span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">10+ years of experience in management and validation.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Current driver’s license and auto insurance</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<br></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 vacation</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Paid sick leave</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>",
    "compensation": "Hourly TBD",
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    "seekPromoted": false,
    "jobCategoryId": "18385",
    "jobOpeningName": "Project Manager",
    "departmentLabel": "Validation",
    "jobOpeningStatus": "Open",
    "minimumExperience": "Experienced",
    "jobOpeningShareUrl": "https://qualityagents.bamboohr.com/careers/5",
    "employmentStatusLabel": "Full-Time"
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}