Specialist I, Quality Labeling - San Diego

Werfen • San Diego, CA

11d • $65,000 - $90,000

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Overview
Position Summary
The Specialist, Quality Labeling is responsible for coordinating the review and approval of product related labeling to support Marketing and Regulatory activities. The Specialist, Quality Labeling will manage labeling projects and track and report on the progress of the projects. The Specialist, Quality Labeling will manage translation projects and deadlines.
This is a salaried position compensating $65,000 - $90,000 annually.

Requirements

• Ability to work cross-functionally
• Ability to manage multiple tasks and remain flexible to changing priorities
• Ability to complete projects and assignments efficiently and appropriately
• Bachelor’s degree required
• One (1) year experience within a regulated medical device, in vitro diagnostic or pharmaceutical environment
• Computer literacy required; proficient with the Microsoft Office suite (Excel, Word, PowerPoint, Outlook)

Nice To Haves

• Knowledge of Adobe Creative Suite software (Adobe InDesign, Adobe Illustrator, Adobe Acrobat)
• Knowledge of graphic design software (Adobe Creative Suite – Adobe Photoshop, Adobe InDesign, Adobe Illustrator, Adobe Acrobat) is preferred
• Detail-oriented; strong analytical and organizational skills
• Ability to work with minimal supervision; also, able to work as part of a team
• Good written and verbal communication skills
• Ability to prioritize urgent matters
• Ability to perform a high volume of work with speed and accuracy
• Demonstrated accuracy and completeness of records
• Ability to meet department goals
• Ability to support changing business needs
• Understanding of FDA, international regulations as well as good documentation practices
• Demonstrated ability to coordinate and support labeling activities

Responsibilities

• Coordinate labeling review, obtain internal approvals, and ensure implementation of new and revised labeling in accordance with applicable regulations, directives, standards and policies
• Liaise with Marketing, Regulatory Affairs, Supply Chain, Engineering, Clinical, and Manufacturing as needed in the labeling review process
• Work with Marketing Product Managers to confirm the labeling content’s accuracy and that it meets user needs
• Track translation projects. Manage translation priorities and delivery timelines.
• Manage internal documentation requirements including change controls, translations, and artwork/images
• Assist with proofreading product labeling redlines and final content
• Ensure and maintain compliance with the company’s Quality System requirements through training and adherence to policies, procedures and processes.
• Work on assigned projects as needed

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level