Quality Chemist III

Glaukos San Clemente , CA 92674

Posted 6 days ago

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world's leading causes of blindness.

The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression.

The company's second-generation MIGS device, the iStent inject Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject, measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.

In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol "GKOS". The company was founded in 1998 and is based in San Clemente, California.

Position Overview:

The Quality Chemist III, based in San Clemente, California, must have GMP analytical testing experience, method transfer and validation experience. The Quality Chemist III will be responsible for developing, implementing analytical methods, creating/revising GMP documents, testing raw materials, performing in-process and final product release, and maintenance of the pharmaceutical stability program. The Quality Chemist III supports the manufacture of product formulations including reviewing Batch records, lot release, executing investigations.

Responsibilities:

  • Performing quality control testing and/or release of raw materials, intermediates, in-process materials, and Active Pharmaceutical Ingredients in accordance to United States Pharmacopeia, other Rest of World standards (JP, EU, etc.), and FDA cGMP requirements

  • 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.

  • Oversight and control of external testing laboratories, including compliance with regulations, review of reports, and scheduling testing.

  • Develop and maintain a GMP product stability program in accordance with ICH guidelines.

  • Execution and/or approval of qualification, validation and stability protocols and/or reports

  • Ensuring that the quality control laboratory is functional and equipped with equipment/utensils and test materials as needed and in a state of compliance

  • Operate a variety of test equipment, such as HPLC, spectrophotometer, pH meter, filtration devices, hot plates, TDS, Moisture Apparatus, Melting Point, balances, etc.

  • Troubleshoot, clean and maintain instruments, glassware and equipment

  • Oversee the proper qualification and calibration of analytical equipment and/or approval of calibration results

  • Prepare periodic and special reports concerning quality control and results of laboratory tests; prepare analytical results reports to relay qualitative and quantitative data.

Experience:

  • Must have strong analytical skills, ability to troubleshoot analytical methods and technical writing abilities.

  • GLP/GMP experience required

  • Analytical experience (USP, EP, JP etc.)

  • Regulatory knowledge (FDA, ISO, ICH, etc.)

Knowledge, Skills, and Abilities:

  • Create a positive work environment

  • Ability to manage simultaneous projects.

  • Knowledge of quality management systems and corrective action programs.

  • Ability to work with teams and lead decision-making processes in a team environment.

  • 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.

  • Good interpersonal, project management and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues.

  • Ability to work well under pressure in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines.

  • Experienced performing in-depth investigations, i.e. out of specification (OOS)

  • 4+ years' experience

Education:

  • Bachelors of Science in chemistry, biochemistry, or related field (required); masters preferred

We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, restricted stock units, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our 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: https://www.themuse.com/companies/glaukoscorporation

Glaukos has been recognized by the Orange County Register as one of the best companies to work for in in Orange County, check out the link https://www.ocregister.com/2018/12/07/top-workplaces-2018-see-the-list-of-all-140-orange-county-honorees/

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.


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VIEW JOBS 3/15/2019 12:00:00 AM 2019-06-13T00:00 Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company's second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA. In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol "GKOS". The company was founded in 1998 and is based in San Clemente, California. Position Overview: The Quality Chemist III, based in San Clemente, California, must have GMP analytical testing experience, method transfer and validation experience. The Quality Chemist III will be responsible for developing, implementing analytical methods, creating/revising GMP documents, testing raw materials, performing in-process and final product release, and maintenance of the pharmaceutical stability program. The Quality Chemist III supports the manufacture of product formulations including reviewing Batch records, lot release, executing investigations. Responsibilities: * Performing quality control testing and/or release of raw materials, intermediates, in-process materials, and Active Pharmaceutical Ingredients in accordance to United States Pharmacopeia, other Rest of World standards (JP, EU, etc.), and FDA cGMP requirements * 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. * Oversight and control of external testing laboratories, including compliance with regulations, review of reports, and scheduling testing. * Develop and maintain a GMP product stability program in accordance with ICH guidelines. * Execution and/or approval of qualification, validation and stability protocols and/or reports * Ensuring that the quality control laboratory is functional and equipped with equipment/utensils and test materials as needed and in a state of compliance * Operate a variety of test equipment, such as HPLC, spectrophotometer, pH meter, filtration devices, hot plates, TDS, Moisture Apparatus, Melting Point, balances, etc. * Troubleshoot, clean and maintain instruments, glassware and equipment * Oversee the proper qualification and calibration of analytical equipment and/or approval of calibration results * Prepare periodic and special reports concerning quality control and results of laboratory tests; prepare analytical results reports to relay qualitative and quantitative data. Experience: * Must have strong analytical skills, ability to troubleshoot analytical methods and technical writing abilities. * GLP/GMP experience required * Analytical experience (USP, EP, JP etc.) * Regulatory knowledge (FDA, ISO, ICH, etc.) Knowledge, Skills, and Abilities: * Create a positive work environment * Ability to manage simultaneous projects. * Knowledge of quality management systems and corrective action programs. * Ability to work with teams and lead decision-making processes in a team environment. * 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. * Good interpersonal, project management and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues. * Ability to work well under pressure in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines. * Experienced performing in-depth investigations, i.e. out of specification (OOS) * 4+ years' experience Education: * Bachelors of Science in chemistry, biochemistry, or related field (required); masters preferred We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, restricted stock units, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our 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: https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the Orange County Register as one of the best companies to work for in in Orange County, check out the link https://www.ocregister.com/2018/12/07/top-workplaces-2018-see-the-list-of-all-140-orange-county-honorees/ 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. Glaukos San Clemente CA

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