Document Control Coordinator II

<p class=""p1"">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.</p>

San Clemente, CA


<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>

keywords: quality assurance,execute,support,receive,document,design,training,oversee,technology,maintenance,degree,environment,pharmaceutical,teamwork,organization,technology,experience,communication

Full time

Overview: As part of the Quality Systems organization, the position is responsible for the daily processing, review, and managing of GxP document change packets within the document management system utilizing electronic software in compliance with Glaukos&rsquo;&nbsp;Quality Management System and regulatory body standards.&nbsp;Additionally, the coordinator will execute with generation, issuance, maintenance, and/or archival of logbooks, analytical notebooks, design history records, master batch records, controlled forms and other GxP/QMS records.
Responsibilities: <p>Support the implementation and administration of electronic and physical record documentation processes and systems, including:</p> <ul> <li>Oversee the system responsible for creating, revising, and releasing company Standard Operating Procedures (SOP), Policies, Work Instructions (WI), drawings, protocols, reports, and other GxP documents.</li> <li>Serve as the document control reviewer and/or approver on documentation managed through the electronic Document Management System, ensuring documents and records comply with established procedures and requirements, appropriate functional area representatives are involved in the review and/or approval and training information is accurate, complete and appropriate training needs are identified.</li> <li>Serve as SME of the document management process and provide support to personnel for document change management.</li> <li>Use Excel Spreadsheets and/or Access database for generation of metrics on Document Management performance.</li> <li>Design forms and new formats which are used as templates for controlled and development documentation.</li> <li>Train new users on functionality, navigation, and use of the electronic Document Management System.</li> <li>Receive and archive/file executed quality-related documentation and records (physical records) in a secure documentation area onsite and offsite&mdash;control access to onsite documentation area(s) and track document and record submission and removal activities.</li> <li>Support in creating, assigning numbers to, and tracking the issuance, closure, and reconciliation of logbooks and laboratory notebooks. Maintain and archive quality logbooks, as required, in accordance with appropriate procedures.</li> <li>Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.</li> <li>Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.</li> <li>Provide document system support and guidance to internal customers and expertise on document content and effective document design to authors</li> </ul>
Requirements: <ul> <li>Associates Degree in Business Administration or a related field; Or an equivalent combination of education and work experience required.&nbsp;&nbsp;Bachelor's degree in a science preferred.</li> <li>3-8 years of industry experience</li> <li>Demonstrated personal computer skills including spreadsheet, word processing, basic powerpoint, data base management, and specialized applications that support the Site&rsquo;s documentation processes.</li> <li>Ability to work in a highly matrixed and geographically diverse business environment.</li> <li>Ability to work within a team and as an individual contributor in a fast-paced, changing environment.</li> <li>Ability to leverage and/or engage others to accomplish projects.</li> <li>Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.</li> <li>Multitasks, prioritizes, and meets deadlines in timely manner.</li> <li>Strong organizational and follow-up skills, as well as attention to detail is a must.</li> <li>Pharmaceutical experience with working knowledge of ISO13485, 21CFR820, and 21CFR210/211 preferred.</li> </ul> <br /> <p><strong>Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.</strong></p> <p>These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.</p> <p>Those may seem like big aspirations, but 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 eyesight of people worldwide. And because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.</p> <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! Check out our profile on The Muse to get an inside look at our company culture. Glaukos Corporation has been Certified as a Great Place to Work the last two years!</p>