Labeling Associate (ADX-22-21)
Labeling Associate (ADX-22-21)
COMPANY SUMMARY:
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
POSITION SUMMARY:
We are looking for an experienced and motivated Labeling Associate. As a member of our team you will be working in a collaborative environment. The labeling associate responsible for assisting in all labeling coordination activities necessary to develop, generate, revise and assure the integrity of product labels. The successful candidate will be responsible:
RESPONSIBILITIES:
- Ability to function well under pressure and balance multiple projects
- Work with Regulatory Affairs for labeling creation
- Proactive suggest improvements to labeling documents, processes and quality
- Must be highly organized and have the ability to meet critical timelines
- Maintain labeling system
- Support labeling inspection/audit readiness activities
- Ensures that all labeling components are appropriately maintained according to relevant laws and regulations
- Ensures compliance with new formatting are appropriate maintained according to relevant laws and regulations
- Act as labeling operations subject matter expert
- Ability to recognize and escalate issues
- Ability to solve problems and work effectively in a team environment
- Proofreading of labeling documents
- Ability to communicate amongst cross functional teams
REQUIREMENTS:
- High School Diploma or equivalent experience
- Experience with Medical Device Labels
- Exceptional attention to detail
KEY ATTRIBUTES:
- Experience working in regulated environments (ISO, FDA)
- Proficient in Adobe, Microsoft Word, Excel, and Microsoft Outlook
- Excellent written and verbal communication skills
- Detail oriented with strong communication and organization skills
- Ability to learn technical information provided in trainings