Quality Assurance Specialist I/II QMS (ADX-207-19)
Quality Assurance Specialist I/II (ADX-207-19)
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 will provide support in the quality system area of Change Control Additionally, the Quality Assurance Specialist may provide support to one or more additional quality system area(s).
RESPONSIBILITIES:
- Provide support for the maintenance of the change control management program.
- Assist with internal and external audit activities.
- Assist with management of Nonconformance Reports, Temporary Deviations, and Corrective and Preventive Action Reports, as applicable.
- Identify improvements by analyzing the current business/system processes and recommending improvements within the scope of the change control management program.
- Maintain compliance with all company policies, quality systems, procedures, and ISO and GMP requirements.
- Work with cross-functional teams in problem-solving, project completion and system improvements.
- Assist in collecting and evaluating data to support quality metrics, as applicable to the change control program
- 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 the supervisor.
QUALIFICATIONS:
- 1-3 years experience in a quality role in a FDA-regulated environment (Level 1)
- 3-5 years experience in a quality role in a FDA-regulated environment (Level 2)
- Knowledge of ISO and GMP
- Medical Device experience 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:
Bachelor’s Degree (science discipline preferred) or equivalent experience