Quality Assurance Specialist I/II, RUO (ADX-72-20)
Quality Assurance Specialist I/II, RUO (ADX-72-20)
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 Specialist I/II, RUO will provide quality assurance support in the Research Use Only (RUO) in-vitro diagnostic (IVD) manufacturing and quality control operations.
RESPONSIBILITIES:
- Review and approve documentation related to manufacture and testing of RUO materials
- Provide support to create documentation that will support manufacturing and testing of RUO materials.
- Process customer complaints associated with RUO materials.
- Manage RUO equipment including scheduling of maintenance and calibration.
- Assist and/or lead continuous improvement and LEAN projects
- Identifies improvements by analyzing the current business/system processes and recommending improvements within the scope of their focus area(s)
- Maintain compliance with all company policies and procedures
- Ability to work with cross-functional teams in problem solving.
- Assist in collecting and evaluating data to support quality metrics for RUO.
- 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.
- Perform other duties as assigned by supervisor.
QUALIFICATIONS:
- Level 1: 1-2 years experience working as a quality representative in a technical environment
- Level 2: 3-5 years experience working as a quality representative in a technical environment
- Previous experience with LEAN preferred.
- Attention to detail with an ability to follow directions for creating quality system records.
- Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
- Ability to work with minimal direction, and utilize good problem-solving skills.
- Excellent planning and organization skills.
- Effective analytical skills.
EDUCATION:
- Associates/ Bachelor’s Degree (science discipline preferred) or equivalent experience