Sr. Quality Assurance Consultant

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      "state": "Maryland"
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    "departmentLabel": "Validation",
    "employmentStatusLabel": "Full-Time"
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    "location": {
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      "state": "Maryland",
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      "addressCountry": "United States"
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    "datePosted": "2025-05-05",
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    "description": "<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Quality Agents, LLC is a service company that offers validation and quality expertise to the pharmaceutical and biotechnology industries.  Our Senior Quality Assurance Consultants are leading service providers to our clients providing GMP support.  The individual will coordinate Quality Assurance activities with the client and meet timelines. </span></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> </span></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Responsibilities include:</span></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> </span></p>\n<ul>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Provides high level resolution of root cause and corrective action items</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Develops quality systems/procedures and provides QA guidance</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Contributes to the QA planning and risk assessment activities</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Leads or co-audits vendors, internal and external systems</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Conducts investigations of GMP related issues and creates corrective action plans</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Reviews Environmental monitoring and additional QC data</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Interprets regulatory authority regulations and guidelines to verify compliance</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Administers and maintains various Quality Management Systems, including: change management, deviation management, document control, records management, and GXP training management</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Complies with all applicable policies regarding health, safety, and environmental policies</span></li>\n</ul>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> </span></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Skill Level and Requirements:</span></p>\n<ul>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> Ability to problem solve and troubleshoot.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> Technical writing ability and use of Microsoft Word, Excel, Power point, and Project</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> Customer service experience in a scientific field is desired.</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> BS in a technical discipline (Engineering, chemistry, microbiology, biology)</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> Energetic, results-driven with excellent organizational and prioritization 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</ul>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> </span></p>\n<p><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\">Minimum Requirements:</span></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)</span></li>\n<li><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> 5-10 years of experience in at least one of the following areas: Quality Assurance, equipment/utility qualifications, process validation, analytical method validation, or cleaning 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><span style=\"color: rgb(0, 0, 0); font-family: helvetica; font-size: 10pt;\"> </span></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<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 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>",
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    "employmentStatusLabel": "Full-Time"
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