<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 />Base Salary Range: $71,700 - $93,200</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> https://www.glaukos.com/

keywords: position summary,compensation,review,assist,prepare,education & experience,skills

Full time

Base Salary Range: $71,700 - $93,200

Overview: <p>The Microbiologist/QA Engineer- Pharma and Medical Devices - position will be based in San Clemente, CA and will directly support the manufacture of innovative ocular medical devices and pharmaceuticals.&nbsp;This role includes ensuring proper execution of Environmental Monitoring tasks, reviewing routine and event-based environmental related project protocols, validations, reports, and data assessments. The candidate will assist with EM testing, bioburden testing, growth promotion and other microbiological testing within the lab.</p> <p><br />The candidate will coordinate and monitor EM related activities to ensure quality and on time completion of EM related tasks. The candidate is also expected to work collaboratively with internal cross-functional groups - R&amp;D, Operations, Facilities - and with external contract vendors.<br /><br /><br /><br /></p>
Responsibilities: <ul> <li>Working within the ISO classified areas.</li> <li>Environmental Monitoring sampling of ISO classified areas.</li> <li>Overseeing external contractors while performing EM sampling activities.</li> <li>Entering and reviewing EM data generated during EM sampling activities.</li> <li>Assisting with EM data trending.</li> <li>Participate and assist with companywide Gowning Training.</li> <li>Review and approved Facilities Data Logs.</li> <li>Review and approve BMS system for cleanrooms.</li> <li>Prepare and update of the GMP/ISO procedures in the area of responsibility.</li> <li>Report writing (investigations, writing final reports).</li> <li>Other duties as assigned by management.</li> </ul>
Requirements: <ul> <li>Bachelor's Degree in Microbiology, Biology, or Biochemistry.&nbsp;</li> <li>2-5 years of experience in microbiology GDP experience.&nbsp;</li> <li>Environmental Monitoring experience required.</li> <li>Manufacturing or production experience required.</li> <li>Solid Understanding of cGMPs.</li> <li>Understanding and working experience in classified environments including ISO 14644.</li> <li>Experience working in a regulated industry, FDA preferred.</li> <li>Good written and verbal communication skills and ability to collaborate and interact with a team.</li> <li>Strong computer skills, documentation skills, and attention to detail.</li> <li>Knowledge of MS Office, MS Word and Excel is required.</li> <li>Adaptable to changing priorities in a fast-paced environment, positive attitude.</li> <li>Position is First Shift, but Second Shift and weekends may be required.</li> <li>Minimal travel required between Glaukos campuses - San Clemente &amp; Aliso Viejo.</li> </ul> <p>&nbsp;</p> <p><strong>Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.</strong>&nbsp;</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! 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>