QC Chemist III

<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

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: position summary,duties,analysis,other duties,prepare reports,laboratory,experience,knowledge, skills & abilities,education

Full time

Overview: <h2 class="job-details__description-header text-color-secondary font-family-secondary" data-bind="i18n: 'job-details.employer-description-title'">ABOUT US</h2> <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> <p>&nbsp;</p> </div> <p><strong>#DareToDoMore @ Glaukos - Join Our Growing Quality Team as a QC Chemist III</strong></p> <p><strong>How will you make an impact?</strong></p> <p>The Quality Control Chemist III must have extensive GMP analytical testing experience, method transfer and validation experience.&nbsp; The QC Chemist III will be responsible for developing, implementing analytical methods, creating/revising GMP documents, testing raw materials, performing in-process and final product release.&nbsp;</p>
Responsibilities: <ul> <li>Performing quality control testing and/or release of cGMP materials (for example, advanced Intermediates and Active Pharmaceutical Ingredients) in accordance to cGMP requirements</li> <li>Execution and maintenance of Quality Control related documentation (QC SOPs and methods, test methods, analytical validation and/or qualification, reference standard qualification, and stability studies</li> <li>Ensuring that the quality control laboratory is functional and equipped with equipment/utensils and test materials as needed and in a state of compliance</li> <li>Set up instruments and conduct sample tests; utilize a variety of methods to assure compliance to established standards and testing controls</li> <li>Troubleshoot, clean and maintain instruments, glassware and equipment; conduct preliminary diagnostic test on equipment</li> <li>Qualification and calibration of analytical equipment and/or approval of calibration results</li> <li>Preparation and execution of qualification, validation and stability protocols and preparation of reports</li> <li>Perform a variety of analytical laboratory testing of raw material, processed material and finished products and assure compliance with applicable laws, rules and regulations</li> <li>Operate a variety of test equipment, such as HPLC, spectrophotometer, pH meter, filtration devices, hot plates, TDS, Moisture Apparatus, Melting Point, balances, etc.</li> <li>Conduct a variety of analytical lab tests in compliance with standard testing methods, procedures and regulations; implement quality control specifications</li> <li>Interpret test results and prepare and submit reports related to test results</li> <li>Perform, interpret, evaluate and record standard process control laboratory tests on</li> <li>Perform calculations as needed and record results; notify appropriate personnel of abnormal or critical results and significant changes in lab results</li> <li>Assure materials meet standards of cleanliness to assure accurate test results</li> <li>Assure an adequate supply of test materials to perform daily testing; perform preventive maintenance on equipment</li> <li>Oversees laboratory equipment (PM, Calibrations), procurement and validation of analytical equipment/supplies</li> <li>Prepare periodic and special reports concerning quality control and results of laboratory tests; prepare analytical results reports to relay qualitative and quantitative data; submit to manager of quality</li> </ul> <p><br /><br /></p>
Requirements: <p><strong>Experience</strong></p> <ul> <li>Bachelors of Science in Chemistry, Biochemistry, or Related Field Required; Masters Preferred.</li> <li>5-8 years&rsquo; experience.&nbsp;</li> <li>Experienced performing in-depth investigations, i.e. out of specification (OOS), must have strong analytical skills, ability to troubleshoot analytical methods and technical writing abilities.</li> <li>GLP/GMP experience required.</li> <li>Analytical experience (USP, EP, JP etc.).</li> <li>Regulatory knowledge (FDA, ISO, ICH, etc.).</li> <li>Pharma/Medical Device cGMP, GMP&nbsp;manufacturing experience.</li> </ul> <p><strong>Knowledge, Skills, and Abilities</strong></p> <ul> <li>Helping create a positive work environment.</li> <li>Ability to manage simultaneous projects.</li> <li>Demonstrated strong leadership, team building and advanced coaching skills.</li> <li>Ability to work with teams and lead decision-making processes in a team environment.</li> <li>Excellent communicator with the ability to influence and persuade across all levels of the organization as well as with suppliers and customers, exercising a high degree of tact and diplomacy to accomplish objectives.</li> <li>Good interpersonal, project management and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues.</li> <li>Ability to build, coach and motivate high performance teams, while holding employees accountable for results.</li> <li>Ability to work well under pressure in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines.</li> <li>Knowledge of quality management systems and corrective action programs.</li> </ul>