Document Control Associate

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Glaukos is an equal opportunity employer and makes employment decisions on the basis of merit. Glaukos participates in E-Verify. The Company policy prohibits discrimination based on race, color, creed, gender, gender identity, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, sexual orientation, covered veteran status, or any other consideration made unlawful by applicable federal, state, or local laws. It also prohibits unlawful discrimination based on the perception that anyone has any of those characteristics, or is associated with a person who has or is perceived as having any of those characteristics.

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Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our 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. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  

Position Overview:

The Quality Records and Document Control Associate based in San Clemente, California, will support the maintenance and retention of manufacturing and quality system records.  This individual will also create and maintain the training roles and records in CATSWeb.

Responsibilities:  

Quality Records:

·     Coordinate and maintain the manufacturing and quality records retention processes, including scanning, filing, off-site storage and retrieval

·     Coordinate R&D Lab Notebook assignment and maintenance

 

Pharma Records Support

·     Create Logbooks to support pharma manufacturing and testing activities

·     Initiate batch records for pharma manufacturing

·     Coordinate QC Lab Notebook assignment and maintenance

 

Document Control/Training Management system:

·     Create training roles for new employees in CATSWeb

·     Modify training roles in support of organizational changes

·     Create and maintain OJT training records in CATSWeb

·     Assist with processing Document Change Requests (DCRs)


Work Experience:

•     Experience in FDA regulated industry preferred

 

Knowledge, Skills and Abilities:

•     Attention to detail and accuracy a must

•     Must be organized

·     Basic computer program knowledge, including Microsoft Word and Excel

·     Electronic documentation system experience preferred

·     Must be able to lift 25 lbs



         

Education:

  • Associate's degree, preferred

 

We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 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 Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf 

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.

 

 

 

Location: Quality Assurance in San Clemente, CA
Apply for this Position
Apply at: https://glaukos.synchr-recruit.com/job/95274/document-control-associate