Quality Assurance Training Specialist II 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.
As the QA Training Specialist, you will assist in maintaining the quality system compliance on a day-to-day basis with a focus on QMS training requirements and compliance. You will also act as the account administrator for the eQMS/LMS (Arena) platform.Responsibilities:
- Account Administration for Arena (eQMS)
- User access control in accordance with approved procedures
- Quality system onboarding/offboarding
- Develop and revise quality process workflows
- Periodic audits of users and system access.
- Assist presenting QMS training program in audits and inspections.
- Provide new hire/refresher training on use of Arena (eQMS)
- Assist with internal and external audits and follow up on required
- Participate on team problem solving related to Complaints, Nonconformance reports, Corrective and Preventative Actions
- Maintain compliance with all company policies and quality systems.
- Create, review, and revise personnel training plans
- Ensure timely completion of QMS training assignments
- Provide reporting and tracking of personnel training records
- Review, understanding, and compliance with Invitae HIPAA Security policies and
- Safeguard the privacy and security of protected health information and European Union personal
- Processing and handling of European Union personal data only as directed by Invitae for purposes of personalized molecular
- Minimum B.S/B.A. preferably in a technical field
- 2+ years working in a regulated industry (Med device, Pharma)
- High degree of proficiency with document and presentation creation.
- Experience administering an eQMS/LMS platform
- Experience developing and delivering training content in a regulated environment
- Driven to perform
- Self-directed: needs minimal supervision
- Able to organize, prioritize, and efficiently move projects forward.
- Ability to interact with multiple disciplines and communicate clearly and effectively verbally and in
- Strong communication and presentation skills.
- Ability to utilize good problem-solving
- Ability to multitask and work within a fast-paced dynamic team
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
**Compensation for the role will depend on a number of factors, including a candidate’s geographic location, qualifications, skills, competencies and experience and may fall outside of the range shown. Expected Pay Rate in Colorado from: $86,160.
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.