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Glaukos Corporation

Sr. Labeling Coordinator

Mission Viejo, CA

Job Description
GLAUKOS IS GROWING! Sr. Labeling Coordinator Opportunity (Aliso Viejo, CA)

How will you make an impact?

This position is responsible for the support and coordination of activities which ensure Glaukos product labeling meets established standards of quality, including process improvement and enhancement.

What will you do?

Labeling Control

  • Work with the Manager, Labeling Compliance to ensure Glaukos labels are compliant to regulatory requirements and are maintained in the Glaukos quality system.
  • Work with the Manager, Labeling Compliance to ensure accurate labeling drawings, specifications and artwork are available within the document control system
  • Work with the Manager, Labeling Compliance to ensure the control of labels is compliant to procedures throughout the facility.
Labeling Development

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  • Use training received on the job to create or revise product labels including the design and layout of the artwork
  • Coordination with vendors to obtain language translations for labels
  • Coordination with vendors who will print labels for Glaukos. Ensure vendors are fully qualified and maintain label version control.
  • Use training received on the job to ensure the proper icons and information are on the labels, as well as consistency within and across product lines as applicable
  • Work with the Manager, Labeling Compliance to assist updating specifications, drawings and artwork for labeling changes
  • Process all new labels and changes through the ECO process
  • Provide receiving inspection with gages where applicable.
Labeling Committee
  • Schedule and participate in labeling committee meetings to review and approve new or revised label changes.
  • Ensure all labeling committee meetings are properly documented and maintain records.
Other duties
  • Assist in maintaining and assigning of barcodes for both device and pharma products in the Global UDI Database through GS1
  • Other duties as assigned
How will you get here?

Experience
  • Bachelor's Degree preferred. HS Diploma acceptable with applicable experience.
  • Sr Level: 5+ years of industry and leadership experience
Knowledge, Skills, and Abilities
  • Must have excellent documentation skills
  • Attention to detail and accuracy a must
  • Medical device experience and working knowledge of QSR preferred
  • Medical device complaint experience preferred
  • Microsoft Office experience (Word, Excel, PowerPoint)
  • Experience with labeling standards and worldwide requirements preferred
  • Team player, good written/oral communicator
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.

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'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.

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 & 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!

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.

About Us
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.

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-the iStent®-in the United States, followed by our next-generation iStent inject ® device in September 2018 and iStent inject ® W in September 2020.

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.

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 "GKOS". Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex including sexual orientation and genderidentity, national origin, disability, protected Veteran Status, or any othercharacteristic protected by applicable federal, state, or local law.

Client-provided location(s): Aliso Viejo, CA, USA
Job ID: glaukos-1019
Employment Type: Other

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