Quality Assurance Associate (Records Maintenance)(ADX-17-20)
Quality Assurance Associate-Records Maintenance (ADX-17-20)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
POSITION SUMMARY:
The Quality Assurance Associate (Records Maintenance), reporting to the Quality Director/Manager, will help maintain the Quality System records for the organization. They will help ensure compliance with relevant ISO standards and FDA regulations.
RESPONSIBILITIES:
- Record digitization
- Organization of records, ensuring cross-departmental access
- Coordinating with third-party organizations for offsite storage of records
- Helping to develop procedures that improve the accessibility of records, consistency in the organization, and time from creation to archival
- Additional duties as assigned
- Review, understanding, and compliance with ArcherDX 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 ArcherDX for purposes of personalized molecular pathology.
QUALIFICATIONS:
- Attention to detail
- Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing
- Ability to work independently, and utilize good problem-solving skills
- Ability to multitask and work within a fast-paced dynamic team environment
- Experience with quality assurance desirable
EDUCATION:
- Associates degree preferred and/or applicable experience