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Senior QA Associate, Supplier Quality - PBS Biotech - Career Page

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"https:\/\/pbsbiotech.applytojob.com\/apply\/mCdqNiwSf1\/Senior-QA-Associate-Supplier-Quality", "title": "Senior QA Associate, Supplier Quality", "description": "<div class=\"WordSection1\"><table align=\"left\" class=\"Table\" style=\"width:631px;border-collapse:collapse;margin-left:9px;margin-right:9px;\" width=\"631\"><tbody><tr><td style=\"width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"color:#a25022;\"><span style=\"font-weight:bold;\"><span style=\"font-size:11pt;\"><span style=\"color:#002060;\">Company: <\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/td><td style=\"width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">PBS Biotech, Inc<\/span><\/span><\/span><\/span><\/td><\/tr><tr><td style=\"width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"color:#a25022;\"><span style=\"font-weight:bold;\"><span style=\"font-size:11pt;\"><span style=\"color:#002060;\">Department:<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/td><td style=\"width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">Quality<\/span><\/span><\/span><\/span><\/td><\/tr><tr><td style=\"width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"color:#a25022;\"><span style=\"font-weight:bold;\"><span style=\"font-size:11pt;\"><span style=\"color:#002060;\">Position\/Title:<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/td><td style=\"width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">Sr. QA Associate, Supplier Quality<\/span><\/span><\/span><\/span><\/td><\/tr><tr><td style=\"width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"color:#a25022;\"><span style=\"font-weight:bold;\"><span style=\"font-size:11pt;\"><span style=\"color:#002060;\">Location:<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/td><td style=\"width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">Camarillo, CA<\/span><\/span><\/span><\/span><\/td><\/tr><tr><td style=\"width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"color:#a25022;\"><span style=\"font-weight:bold;\"><span style=\"font-size:11pt;\"><span style=\"color:#002060;\">Reporting To:<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/td><td style=\"width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">Associate Director, Quality Assurance <\/span><\/span><\/span><\/span><\/td><\/tr><tr><td style=\"width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"color:#a25022;\"><span style=\"font-weight:bold;\"><span style=\"font-size:11pt;\"><span style=\"color:#002060;\">FLSA Status:<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/td><td style=\"width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">Exempt<\/span><\/span><\/span><\/span><\/td><\/tr><tr><td style=\"width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"color:#a25022;\"><span style=\"font-weight:bold;\"><span style=\"font-size:11pt;\"><span style=\"color:#002060;\">Salary Range<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/td><td style=\"width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;\" valign=\"top\">$85,000 - $93,000 - $102,000<\/td><\/tr><\/tbody><\/table>&#160;<div style=\"border-bottom:solid #1d99a0 4.5pt;padding:0in 0in 1pt 0in;\"><br><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"text-transform:uppercase;\"><span style=\"font-weight:bold;\">GENERAL PURPOSE<\/span><\/span><\/span><\/span><\/span><\/div><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">This role supports the implementation and continuous improvement of PBS&#8217;s Quality Management System (QMS) and is responsible for management of programs such as supplier qualification, supplier quality performance management, and supporting supplier audits. This role supports internal audits, customer audits, and regulatory affairs including regulatory related requests.<\/span><\/span><\/span><\/span><br>&#160;<div style=\"border-bottom:solid #1d99a0 4.5pt;padding:0in 0in 1pt 0in;\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"text-transform:uppercase;\"><span style=\"font-weight:bold;\">Responsibilities<\/span><\/span><\/span><\/span><\/span><\/div><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><i><span style=\"font-size:8pt;\">Essential functions of the job are listed below.&#160; Other responsibilities may also be assigned.&#160; Please note that the essential functions may vary depending on department size, organizational structure and\/or geographic location.&#160; Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.<\/span><\/i><\/span><\/span><\/span><br>&#160;<div style=\"border-bottom:solid #1d99a0 2.25pt;padding:0in 0in 1pt 0in;\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-weight:bold;\"><span style=\"font-style:italic;\"><span style=\"font-weight:normal;\"><span style=\"font-style:normal;\">Support the QMS implementation, ensure suitability, and continuously improve the structure and processes<\/span><\/span><span style=\"font-weight:normal;\"><span style=\"font-style:normal;\">.<\/span><\/span><span style=\"font-weight:normal;\"><span style=\"font-style:normal;\"> Manage and oversees all aspects of the Supplier Qualification process. Support GxP compliance and regulatory related requirements, external and internal audits, and customer and suppliers&#8217; requests. Interface with QMS users to improve assigned QMS processes and procedures.<\/span><\/span><\/span><\/span><\/span><\/span><br><br><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-weight:bold;\"><span style=\"font-style:italic;\">Primary Responsibilities<\/span><\/span><\/span><\/span><\/span><\/div><ul><li><span><span style=\"font-size:10.5pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\"><span style=\"line-height:115%;\">Support the company&#8217;s efforts for CGMP qualification and ISO Certification.<\/span><\/span><\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Supports aspects of the Supplier Qualification process including metrics and risk management documents.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Supports the Supplier Quality surveillance plan and activities.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Manage supplier qualification activities for low risk (low criticality) to medium risk (medium criticality) suppliers.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Partners with Supply Chain for management and follow up of Supplier Corrective Actions Reports (SCARs) and implements identified improvements and actions if needed.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Initiate, review, and approve SCARs.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Escalate supplier quality issues to stakeholders.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Manage, perform, and support supplier capability to meet product requirement specifications.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Manage Supplier Change Notifications.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Execute actions associated with Change Management and Corrective\/Preventive Acton's (CAPA), including ownership of these records.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Facilitates Root Cause Analysis and Corrective Action activities with Suppliers as a result of Audit, Compliance, or Product deficiencies.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Member of the Supplier Review Board (SRB) team in providing input and data related to deployment of SQM strategy and monitoring of supplier continuous improvement.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\"><span style=\"line-height:115%;\">Responsible for supporting continuous improvement of SQM processes. <\/span><\/span><\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Performs various administrative activities related to supplier quality information in the PBS Enterprise Resource Planning (ERP) system.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Support Deviations and Customer Complaints where supplier-related deficiencies are involved.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\"><span style=\"line-height:115%;\">Support procedure creation\/updates, training, and data trending\/reporting for Supplier Quality Management.<\/span><\/span><\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\"><span style=\"line-height:115%;\">Supports the deployment of QMS processes and promotes on-going education of the QMS and regulatory requirements including Supplier Quality training for involved departments such as Engineering and Supply Chain.<\/span><\/span><\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\"><span style=\"line-height:115%;\">Supports the tracking &amp; reporting for the quality programs, including development and monitoring metrics that support key performance indicators (KPIs) for the organization. Provides reports to management, as required. Provides and may execute suggested remediation activities.<\/span><\/span><\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\"><span style=\"line-height:115%;\">Identify opportunities for and participate in continuous improvement of the QMS program, which may include seeking feedback from stakeholders.<\/span><\/span><\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\"><span style=\"line-height:115%;\">Maintain a state of inspection readiness and participate in inspection preparation activities.&#160; <\/span><\/span><\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\"><span style=\"line-height:115%;\">Assist in the design and implementation of electronic quality management systems (eQMS) for Supplier Quality Management.<\/span><\/span><\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\"><span style=\"line-height:115%;\">This role is considered a QA function and may provide QA approvals where assigned.<\/span><\/span><\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\"><span style=\"line-height:115%;\">Assignments may vary based on business needs.<\/span><\/span><\/span><\/span><\/span><\/span><\/li><\/ul><\/div>&#160;<div class=\"WordSection2\"><\/div>&#160;<div class=\"WordSection3\"><div style=\"border-bottom:solid #1d99a0 4.5pt;padding:0in 0in 1pt 0in;\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"text-transform:uppercase;\"><span style=\"font-weight:bold;\">Minimum Qualifications<\/span><\/span><\/span><\/span><\/span><\/div><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><i><span style=\"font-size:8pt;\">The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position.&#160; Please note that the minimum qualifications may vary based upon the department size and\/or geographic location.<\/span><\/i><\/span><\/span><br><br><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Minimum of 3 to 4+ years of supplier quality experience including working directly with suppliers.<\/span><\/span><\/span><br><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">3 to 4+ years of experience in a role for medical products in a regulated environment.<\/span><\/span><\/span><\/span><br>&#160;<div style=\"border-bottom:solid #1d99a0 2.25pt;padding:0in 0in 1pt 0in;\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-weight:bold;\"><span style=\"font-style:italic;\">Knowledge\/ Experience<\/span><\/span><\/span><\/span><\/span><\/div><ul><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">3 to 4+ years of experience within a QMS that requires a high degree of supplier management, quality control, ideally GMP quality system, medical device (QSR\/ISO13485), aerospace (AS 9100), ISO 9001, or other similar systems.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">3 to 4+ of experience in a role for medical products in a regulated environment. e.g., medical device, single use medical or biopharma products, or similar field.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:12pt;\">Bachelor&#8217;s Degree &#8211; Engineering, Supply Chain Management, Biotechnology, Logistics or related field of study. <\/span><\/span><\/span><\/span><\/li><\/ul>&#160;<div style=\"border-bottom:solid #1d99a0 2.25pt;padding:0in 0in 1pt 0in;\"><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-weight:bold;\"><span style=\"font-style:italic;\">Skills\/ Abilities Pertinent to This Position<\/span><\/span><\/span><\/span><\/span><\/div><\/div>&#160;<div class=\"WordSection4\"><ul><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">Working knowledge and experience with ERP enterprise resource planning software (e.g., GSS) and electronic quality management systems (e.g., Veeva).<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">Technical writing and ability to write and understand investigation reports.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">Strong verbal communication and presentation skills.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">Ability to use statistical tools for decision-making processes, root cause analysis, and risk assessments.<\/span><\/span><\/span><\/span><\/li><li><span><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">Ability to interface with external suppliers.<\/span><\/span><\/span><\/span><\/li><\/ul><\/div>&#160;<div class=\"WordSection5\"><\/div>&#160;<div style=\"border-bottom:solid #1d99a0 4.5pt;padding:0in 0in 1pt 0in;\"><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"text-transform:uppercase;\"><span style=\"font-weight:bold;\">PHYSICAL DEMANDS<\/span><\/span><\/span><\/span><\/div><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><i><span style=\"font-size:8pt;\">In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job.&#160; Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.<\/span><\/i><\/span><\/span><br><br><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">Must be able to see, hear, speak and write clearly in order to communicate with employees and\/or vendors; manual dexterity required for occasional standing, reaching and lifting of small objects, and operating manufacturing equipment.&#160; May occasionally required to lift various weights up to 25lbs (&lt;25lbs = 1 box of documents&gt; as needed to meet job requirements. <\/span><\/span><\/span><br>&#160;<div style=\"border-bottom:solid #1d99a0 4.5pt;padding:0in 0in 1pt 0in;\"><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"text-transform:uppercase;\"><span style=\"font-weight:bold;\">WORK ENVIRONMENT<\/span><\/span><\/span><\/span><\/div><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><i><span style=\"font-size:8pt;\">In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job.&#160; Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.<\/span><\/i><\/span><\/span><br><br><span style=\"font-size:10.5pt;\"><span style=\"font-family:'Tw Cen MT', sans-serif;\"><span style=\"font-size:11pt;\">This role is primarily office work with some tasks or evaluation performed in a production or lab-like environment.&#160; May occasionally be required to perform some tasks in the following environments: Clean room;&#160; near moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant; Personal protective equipment (vision and hearing) used in plant.<\/span><\/span><\/span><br>&#160;", "datePosted": "2024-11-22", "validThrough": "2025-02-20", "employmentType": "FULL_TIME", "hiringOrganization": { "@type": "Organization", "name": "PBS Biotech", "sameAs": "https:\/\/www.pbsbiotech.com", "logo": "https:\/\/s3.amazonaws.com\/resumator\/customer_20220303192527_FOY84DWB8YPRUZXM\/logos\/20220304154327_PBS_Biotech_Logo_2k.jpg" }, "jobLocation": { "@type": "Place", "address": { "@type": "PostalAddress", "addressLocality": "Camarillo", "addressRegion": "CA", "postalCode": "93010" } }, "experienceRequirements": "Mid Level" } </script> <!-- Style sheets --> <!--[if IE 8]> <style type="text/css">body { min-width: 1140px; 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Please review our open positions and apply to the positions that match your qualifications.</h2> </div> </div> <div class='job-header'> <div class='container'> <h1>Senior QA Associate, Supplier Quality</h1> <div class="job-attributes-container"> <div title="Location"> <i class='fa fa-map-marker'></i>Camarillo, CA </div> <div id='resumator-job-employment' title="Type"> <i class='fa fa-clock-o'></i>Full Time </div> <div id='resumator-job-experience' title="Experience"> <i class='fa fa-graduation-cap'></i>Mid Level </div> </div> <div class="social-tools"> <a class="btn btn-lg btn-gray" data-test="job-board-responsive-share" href="https://pbsbiotech.applytojob.com/app/share/mCdqNiwSf1" target="_blank" role="button" data-track-share-click="Responsive"> <i class="fa fa-share-alt"></i> Share </a> </div> </div> </div> <div class='page-body job-details'> <div class='container'> <div class='row'> <div class='col col-xs-7 description' id="job-description"> <div class="WordSection1"><table align="left" class="Table" style="width:631px;border-collapse:collapse;margin-left:9px;margin-right:9px;" width="631"><tbody><tr><td style="width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="color:#a25022;"><span style="font-weight:bold;"><span style="font-size:11pt;"><span style="color:#002060;">Company: </span></span></span></span></span></span></span></td><td style="width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">PBS Biotech, Inc</span></span></span></span></td></tr><tr><td style="width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="color:#a25022;"><span style="font-weight:bold;"><span style="font-size:11pt;"><span style="color:#002060;">Department:</span></span></span></span></span></span></span></td><td style="width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">Quality</span></span></span></span></td></tr><tr><td style="width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="color:#a25022;"><span style="font-weight:bold;"><span style="font-size:11pt;"><span style="color:#002060;">Position/Title:</span></span></span></span></span></span></span></td><td style="width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">Sr. QA Associate, Supplier Quality</span></span></span></span></td></tr><tr><td style="width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="color:#a25022;"><span style="font-weight:bold;"><span style="font-size:11pt;"><span style="color:#002060;">Location:</span></span></span></span></span></span></span></td><td style="width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">Camarillo, CA</span></span></span></span></td></tr><tr><td style="width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="color:#a25022;"><span style="font-weight:bold;"><span style="font-size:11pt;"><span style="color:#002060;">Reporting To:</span></span></span></span></span></span></span></td><td style="width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">Associate Director, Quality Assurance </span></span></span></span></td></tr><tr><td style="width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="color:#a25022;"><span style="font-weight:bold;"><span style="font-size:11pt;"><span style="color:#002060;">FLSA Status:</span></span></span></span></span></span></span></td><td style="width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">Exempt</span></span></span></span></td></tr><tr><td style="width:170px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="color:#a25022;"><span style="font-weight:bold;"><span style="font-size:11pt;"><span style="color:#002060;">Salary Range</span></span></span></span></span></span></span></td><td style="width:461px;padding:0.1in 0.05in 0in 0in;height:0.1px;" valign="top">$85,000 - $93,000 - $102,000</td></tr></tbody></table>&#160;<div style="border-bottom:solid #1d99a0 4.5pt;padding:0in 0in 1pt 0in;"><br><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="text-transform:uppercase;"><span style="font-weight:bold;">GENERAL PURPOSE</span></span></span></span></span></div><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">This role supports the implementation and continuous improvement of PBS&#8217;s Quality Management System (QMS) and is responsible for management of programs such as supplier qualification, supplier quality performance management, and supporting supplier audits. This role supports internal audits, customer audits, and regulatory affairs including regulatory related requests.</span></span></span></span><br>&#160;<div style="border-bottom:solid #1d99a0 4.5pt;padding:0in 0in 1pt 0in;"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="text-transform:uppercase;"><span style="font-weight:bold;">Responsibilities</span></span></span></span></span></div><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><i><span style="font-size:8pt;">Essential functions of the job are listed below.&#160; Other responsibilities may also be assigned.&#160; Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location.&#160; Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.</span></i></span></span></span><br>&#160;<div style="border-bottom:solid #1d99a0 2.25pt;padding:0in 0in 1pt 0in;"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-weight:bold;"><span style="font-style:italic;"><span style="font-weight:normal;"><span style="font-style:normal;">Support the QMS implementation, ensure suitability, and continuously improve the structure and processes</span></span><span style="font-weight:normal;"><span style="font-style:normal;">.</span></span><span style="font-weight:normal;"><span style="font-style:normal;"> Manage and oversees all aspects of the Supplier Qualification process. Support GxP compliance and regulatory related requirements, external and internal audits, and customer and suppliers&#8217; requests. Interface with QMS users to improve assigned QMS processes and procedures.</span></span></span></span></span></span><br><br><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-weight:bold;"><span style="font-style:italic;">Primary Responsibilities</span></span></span></span></span></div><ul><li><span><span style="font-size:10.5pt;"><span style="line-height:115%;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;"><span style="line-height:115%;">Support the company&#8217;s efforts for CGMP qualification and ISO Certification.</span></span></span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Supports aspects of the Supplier Qualification process including metrics and risk management documents.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Supports the Supplier Quality surveillance plan and activities.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Manage supplier qualification activities for low risk (low criticality) to medium risk (medium criticality) suppliers.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Partners with Supply Chain for management and follow up of Supplier Corrective Actions Reports (SCARs) and implements identified improvements and actions if needed.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Initiate, review, and approve SCARs.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Escalate supplier quality issues to stakeholders.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Manage, perform, and support supplier capability to meet product requirement specifications.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Manage Supplier Change Notifications.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Execute actions associated with Change Management and Corrective/Preventive Acton's (CAPA), including ownership of these records.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Facilitates Root Cause Analysis and Corrective Action activities with Suppliers as a result of Audit, Compliance, or Product deficiencies.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Member of the Supplier Review Board (SRB) team in providing input and data related to deployment of SQM strategy and monitoring of supplier continuous improvement.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="line-height:115%;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;"><span style="line-height:115%;">Responsible for supporting continuous improvement of SQM processes. </span></span></span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Performs various administrative activities related to supplier quality information in the PBS Enterprise Resource Planning (ERP) system.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Support Deviations and Customer Complaints where supplier-related deficiencies are involved.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="line-height:115%;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;"><span style="line-height:115%;">Support procedure creation/updates, training, and data trending/reporting for Supplier Quality Management.</span></span></span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="line-height:115%;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;"><span style="line-height:115%;">Supports the deployment of QMS processes and promotes on-going education of the QMS and regulatory requirements including Supplier Quality training for involved departments such as Engineering and Supply Chain.</span></span></span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="line-height:115%;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;"><span style="line-height:115%;">Supports the tracking &amp; reporting for the quality programs, including development and monitoring metrics that support key performance indicators (KPIs) for the organization. Provides reports to management, as required. Provides and may execute suggested remediation activities.</span></span></span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="line-height:115%;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;"><span style="line-height:115%;">Identify opportunities for and participate in continuous improvement of the QMS program, which may include seeking feedback from stakeholders.</span></span></span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="line-height:115%;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;"><span style="line-height:115%;">Maintain a state of inspection readiness and participate in inspection preparation activities.&#160; </span></span></span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="line-height:115%;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;"><span style="line-height:115%;">Assist in the design and implementation of electronic quality management systems (eQMS) for Supplier Quality Management.</span></span></span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="line-height:115%;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;"><span style="line-height:115%;">This role is considered a QA function and may provide QA approvals where assigned.</span></span></span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="line-height:115%;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;"><span style="line-height:115%;">Assignments may vary based on business needs.</span></span></span></span></span></span></li></ul></div>&#160;<div class="WordSection2"></div>&#160;<div class="WordSection3"><div style="border-bottom:solid #1d99a0 4.5pt;padding:0in 0in 1pt 0in;"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="text-transform:uppercase;"><span style="font-weight:bold;">Minimum Qualifications</span></span></span></span></span></div><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><i><span style="font-size:8pt;">The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position.&#160; Please note that the minimum qualifications may vary based upon the department size and/or geographic location.</span></i></span></span><br><br><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Minimum of 3 to 4+ years of supplier quality experience including working directly with suppliers.</span></span></span><br><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">3 to 4+ years of experience in a role for medical products in a regulated environment.</span></span></span></span><br>&#160;<div style="border-bottom:solid #1d99a0 2.25pt;padding:0in 0in 1pt 0in;"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-weight:bold;"><span style="font-style:italic;">Knowledge/ Experience</span></span></span></span></span></div><ul><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">3 to 4+ years of experience within a QMS that requires a high degree of supplier management, quality control, ideally GMP quality system, medical device (QSR/ISO13485), aerospace (AS 9100), ISO 9001, or other similar systems.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">3 to 4+ of experience in a role for medical products in a regulated environment. e.g., medical device, single use medical or biopharma products, or similar field.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:12pt;">Bachelor&#8217;s Degree &#8211; Engineering, Supply Chain Management, Biotechnology, Logistics or related field of study. </span></span></span></span></li></ul>&#160;<div style="border-bottom:solid #1d99a0 2.25pt;padding:0in 0in 1pt 0in;"><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-weight:bold;"><span style="font-style:italic;">Skills/ Abilities Pertinent to This Position</span></span></span></span></span></div></div>&#160;<div class="WordSection4"><ul><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">Working knowledge and experience with ERP enterprise resource planning software (e.g., GSS) and electronic quality management systems (e.g., Veeva).</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">Technical writing and ability to write and understand investigation reports.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">Strong verbal communication and presentation skills.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">Ability to use statistical tools for decision-making processes, root cause analysis, and risk assessments.</span></span></span></span></li><li><span><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">Ability to interface with external suppliers.</span></span></span></span></li></ul></div>&#160;<div class="WordSection5"></div>&#160;<div style="border-bottom:solid #1d99a0 4.5pt;padding:0in 0in 1pt 0in;"><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="text-transform:uppercase;"><span style="font-weight:bold;">PHYSICAL DEMANDS</span></span></span></span></div><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><i><span style="font-size:8pt;">In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job.&#160; Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.</span></i></span></span><br><br><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">Must be able to see, hear, speak and write clearly in order to communicate with employees and/or vendors; manual dexterity required for occasional standing, reaching and lifting of small objects, and operating manufacturing equipment.&#160; May occasionally required to lift various weights up to 25lbs (&lt;25lbs = 1 box of documents&gt; as needed to meet job requirements. </span></span></span><br>&#160;<div style="border-bottom:solid #1d99a0 4.5pt;padding:0in 0in 1pt 0in;"><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="text-transform:uppercase;"><span style="font-weight:bold;">WORK ENVIRONMENT</span></span></span></span></div><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><i><span style="font-size:8pt;">In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job.&#160; Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.</span></i></span></span><br><br><span style="font-size:10.5pt;"><span style="font-family:'Tw Cen MT', sans-serif;"><span style="font-size:11pt;">This role is primarily office work with some tasks or evaluation performed in a production or lab-like environment.&#160; May occasionally be required to perform some tasks in the following environments: Clean room;&#160; near moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant; Personal protective equipment (vision and hearing) used in plant.</span></span></span><br>&#160; </div> <div class="resumator-mobile-apply-wrapper mobile"> <a id="resumator-mobile-share-button" class="btn" data-test="job-board-responsive-share" href="https://pbsbiotech.applytojob.com/app/share/mCdqNiwSf1" target="_blank" role="button" data-track-share-click="Responsive"> <i class="fa fa-share"></i> Share </a> <button type="button" id="resumator-mobile-apply-button" class='btn'> <i class="fa fa-user-plus"></i> Apply </button> </div> <div id="job-application-form-container" class='col col-xs-5 job-application-form'> <div id="resumator-application-form"> <div class="resumator-resume-text" id="resumator-resume-upload"> <h3 class="resumator-resume-text" id="resumator-resumes-title"> Apply for this position </h3> <div class="required-help-text">Required<i class="asterisk">*</i></div> <div id="resumator-apply-with-indeed-wrapper"> <span id="resumator-indeed-apply-widget" class="indeed-apply-widget" data-indeed-apply-apiToken="e7ead154e87d9b9107701fb9b23d0166117d5716f539c95cde882041de21443d" data-indeed-apply-jobTitle="Senior QA Associate, Supplier Quality" data-indeed-apply-postUrl="https://pbsbiotech.applytojob.com/apply/parse/ia/mCdqNiwSf1?1732690861QUWRTSXZYV" data-indeed-apply-questions="https://pbsbiotech.applytojob.com/apply/get/questions/mCdqNiwSf1?1732690861QUWRTSXZYV" data-indeed-apply-phone="required" data-indeed-apply-jobmeta="" data-indeed-apply-allow-apply-on-indeed="0" > </span> <div class="resumator-external-apply-button indeed"> <div class="logo indeed-logo"></div> <div class="text" id="resumator-apply-with-indeed-text">Apply with Indeed</div> </div> <script> (function(d, s, id) { var js, iajs = d.getElementsByTagName(s)[0]; 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