Job Description:

CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com

Who We Are

Paragon Vision Sciences, Inc., a Cooper Vision specialty eye care company, is a world leading manufacturer of specialty contact lenses and oxygen permeable contact lens materials. Our CRT® lens (a class three medical device) is considered the lens of choice by many eye care professionals around the world. Paragon’s office is located in Gilbert, Arizona.

Why Work With Us

We are certified as a Great Place to Work®! Our environment recognizes each employee as a vital member of the team. Integrity and respect are fundamental to our working relationships. We are friendly, inventive, and dedicated. We don’t quit until the job is done right! Our lenses don’t just change vision, they change lives. Join a team that is passionate about improving other’s visual health and quality of life.

Job Summary:

The Intern Document Control Specialist is responsible for executing the document control and records management process at Paragon Vision Sciences, ensuring documentation accuracy, quality, integrity and compliance to company policy and procedures. Will learn good documentation and the benefits of a quality management system in a medical device FDA regulated facility.

Essential Functions & Accountabilities:

• Processes various types of requests for documents into the Quality Management System, including tracking, scanning, circulation for approval, distribution, and filing.


• Processes and files completed records and documentation, e.g., customer complaints, audit records, corrective actions, device history records, literature reviews, etc..


• Maintains all files stored in the document control storage areas.


• Manages the generation and distribution of new document identifiers and ensures correct naming conventions are used.


• Prepares files for transfer to long-term offsite storage and maintains document retention records.


• Updates and maintains various tracking spreadsheets.


• No travel is required.

CooperVision’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

Qualifications

Knowledge, Skills and Abilities:

• Ability to work effectively with people at all levels of the organization.


• Ability to work under time constraints with multiple projects, and ability to adapt to change.


• Strong attention to detail with each task.


• Intermediate skill in the use of Excel, Word, PowerPoint, and SharePoint (advanced skill preferred).


• Language skills (proficient in reading and writing in English).


• Knowledge of GMP, FDA, and ISO requirements desired.

Work Environment:

• General office environment.


• Prolonged sitting/standing in front of a computer.


• Bending/stooping to access files and file drawers.


• Occasional lifting (approximately 30-35 pounds).

Experience:

• Not required, but prior Internship experience is a plus.

Education:

• Current college student – scientist, engineers that want to see documentation in support of R & D and operations activities in medical manufacturing.

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