Sr. Labeling Coordinator

<p class="">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.<br /><br /><strong>Base Salary Range: $54,200 - $78,500</strong></p>

Aliso Viejo, CA

Glaukos

<h4>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</h4> <h4>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</h4> https://www.glaukos.com/

keywords: about glaukos,compensation,position summary,working with the manager,duties,training,schedule & participate in meetings,education & experience,knowledge, skills & abilities

Full time

Base Salary Range: $54,200 - $78,500

Overview: <p><strong>GLAUKOS IS GROWING! Sr. Labeling Coordinator Opportunity (Aliso Viejo, CA)</strong></p> <div class="basic-formatter" data-bind="html: job().corporateDescription"> <p>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</p> <p>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;<em>inject</em><sup>&reg;</sup>&nbsp;device in September 2018 and iStent&nbsp;<em>inject</em><sup>&reg;</sup>&nbsp;W in September 2020.</p> <p>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</p> <p>Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol &ldquo;GKOS&rdquo;. Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.</p> </div> <p><strong>&nbsp;</strong></p> <p><strong>How will you make an impact?</strong></p> <p>This position is responsible for the support and coordination of activities which ensure Glaukos product labeling meets established standards of quality, including process improvement and enhancement.</p>
Responsibilities: <p>Labeling Control&nbsp;</p> <ul> <li>Work&nbsp;with&nbsp;the&nbsp;Manager, Labeling Compliance&nbsp;to ensure Glaukos labels&nbsp;are compliant to regulatory requirements and are maintained in the Glaukos quality system.&nbsp;&nbsp;</li> <li>Work with the&nbsp;Manager, Labeling Compliance&nbsp;to ensure&nbsp;accurate&nbsp;labeling drawings, specifications and artwork are available within the document control&nbsp;system&nbsp;&nbsp;</li> <li>Work with the&nbsp;Manager, Labeling Compliance&nbsp;to ensure&nbsp;the control of labels is compliant to procedures throughout the facility.&nbsp;&nbsp;</li> </ul> <p>Labeling Development&nbsp;</p> <ul> <li>Use training received on the job to&nbsp;create or revise&nbsp;product&nbsp;labels including the design and layout of the&nbsp;artwork&nbsp;&nbsp;</li> <li>Coordination with vendors to obtain&nbsp;language&nbsp;translations for&nbsp;labels&nbsp;&nbsp;</li> <li>Coordination with vendors who will print labels for Glaukos. Ensure vendors are fully qualified and maintain label version control.&nbsp;&nbsp;</li> <li>Use training received on the job to ensure&nbsp;the proper icons and information are on the labels, as well as&nbsp;consistency within and across product lines as&nbsp;applicable&nbsp;&nbsp;&nbsp;</li> <li>Work with the&nbsp;Manager, Labeling Compliance&nbsp;to&nbsp;assist&nbsp;updating&nbsp;specifications, drawings and artwork for labeling&nbsp;changes&nbsp;&nbsp;</li> <li>Process all new labels and changes through the&nbsp;ECO&nbsp;process&nbsp;&nbsp;</li> <li>Provide receiving inspection with gages where applicable.&nbsp;&nbsp;</li> </ul> <p>Labeling Committee&nbsp;</p> <ul> <li>&nbsp;Schedule and participate in&nbsp;labeling committee meetings to review and approve new or revised label changes.&nbsp;&nbsp;</li> <li>Ensure&nbsp;all labeling committee meetings are properly documented and maintain records.&nbsp;&nbsp;</li> </ul> <p>Other duties&nbsp;</p> <ul> <li>Assist in maintaining&nbsp;and assigning of barcodes for both device and pharma products&nbsp;in the&nbsp;Global UDI Database through&nbsp;GS1&nbsp;&nbsp;</li> <li>Other duties as assigned&nbsp;&nbsp;</li> </ul>
Requirements: <p>Experience&nbsp;</p> <ul> <li>Bachelor&rsquo;s Degree preferred. HS Diploma acceptable with applicable experience.</li> <li>Sr Level:&nbsp;5+&nbsp;years of industry and leadership experience&nbsp;</li> </ul> <p>Knowledge, Skills, and Abilities&nbsp;</p> <ul> <li>Must have excellent documentation&nbsp;skills&nbsp;&nbsp;</li> <li>Attention to detail and accuracy a&nbsp;must&nbsp;&nbsp;</li> <li>Medical device experience and working knowledge of QSR&nbsp;preferred&nbsp;&nbsp;</li> <li>Medical device complaint experience&nbsp;preferred&nbsp;</li> <li>Microsoft Office experience (Word, Excel, PowerPoint)&nbsp;</li> <li>Experience with labeling standards and worldwide requirements&nbsp;preferred&nbsp;&nbsp;</li> <li>Team player, good written/oral communicator&nbsp;&nbsp;</li> </ul> <br /> <p>We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off &amp; paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last two years!</p> <p>Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.</p>