Labeling Associate at Invitae (Formerly ArcherDx)
Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life. We are passionate about what we do!
As a member of our team, you will be working in a collaborative environment. The Labeling Associate will be responsible for assisting in all labeling coordination activities necessary to developing, generating, revising and assuring the integrity of product labels. As well as, assisting with kitting events.
- 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
- Work closely with Quality Assurance, responsible for accurate and thorough document completion.
- Ability to communicate amongst cross functional teams
- Review, understanding, and compliance with Invitae HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by Invitae for purposes of personalized molecular pathology.
- High school diploma / GED required
- 1 year of experience in a cGMP/ISO/FDA regulated facility preferred.
- Experience with Medical Device Labels (preferred)
- Exceptional attention to detail
- One-year experience in a cGMP/ISO/FDA regulated facility preferred.
- Previous experience with temperature-sensitive materials is preferred.
- Previous experience with barcoding systems is preferred.
- 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
- High school / GED diploma
In Colorado, our competitive compensation package includes a base salary starting from $20.00 per hour. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.