Specialist I, Quality Labeling - San Diego

Werfen

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.

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.

Key Accountabilities

Essential Functions:

• 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

Minimum Knowledge & Experience Required for the Position

• 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

Education/Experience

• 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)
• Knowledge of Adobe Creative Suite software (Adobe InDesign, Adobe Illustrator, Adobe Acrobat)

Required Skills

• Computer literacy required; proficient with the Microsoft Office suite (Excel, Word, PowerPoint, Outlook)
• 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

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com