Training Associate (ADX-49-21)
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:
The Training Associate, reporting to the Training Manager, will assist with planning and implementing training programs to help QC team and several other cross functional teams who would need training to perform ArcherDX assays. Function includes assisting the Training Manager in development of training program(s) for regulated and RUO products; assure that relevant procedures (work instructions, forms, and training program(s) are managed and continuously reviewed and improved for compliance and operating efficiencies; ensures that QC department personnel are trained and compliant to perform testing; ensures compliance to medical device and in vitro diagnostic regulations, relevant to the scope of department.
RESPONSIBILITIES:
Job performance will involve a variety of activities including:
- Assist in development and continuous improvement of QC department training program(s) for regulated and RUO products.
- Assist in development and continuous improvement training programs for relevant cross-functional teams
- Assist in the implementation of a proficiency testing program for QC testing personnel.
- Assist in maintenance of training and proficiency testing records.
- Assist to organize the QC laboratory space for quality and efficiency in order to meet regulatory requirements while allowing for a scalable testing and training environment.
- Perform other duties as assigned by supervisor
- Review, understanding, and compliance with ArcherDX HIPAA security policies and procedures.
EXPERIENCE:
- Minimum of 2 years’ experience in laboratory testing
- Previous laboratory experience with statistical data analysis, Next Generation Sequencing, qPCR/PCR and general molecular biology techniques and equipment
- Knowledge of cGMP/CFR/FDA regulations
- Strong leadership and communication skills
KEY ATTRIBUTES:
- Drive and determination
- Ability to work in a fast paced and dynamic environment
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
- Strong communication and presentation skills
- Self-starter
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize and prioritize to efficiently move projects forward
EDUCATION:
- Bachelor's degree required.