Quality Assurance Specialist, II/III (Production/Manufacturing) (ADX-39-20)
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.
- Assigned as direct QA support to production/manufacturing of ArcherDX assay components and processes.
- Support of other Production-related activities including raw materials receipt/transfer/release, labeling verification, kitting verification, QC report review, shipping verification, etc.
- Timely review of batch records (Travelers) and product release.
- Assist with validation activities (IQ/OQ/PQ) of processes, methods, and equipment.
- Assist in managing equipment, including installation and monitoring of maintenance and calibration.
- Assist Quality Engineers with internal and external audits, and follow up on required actions
- Assist with the management of Nonconformance reports, and Corrective and Preventive Actions reports, and complaints.
- Maintain compliance with all company policies, quality systems, and procedures
- Perform other duties as assigned by supervisor
- 2+ years of experience within quality assurance in a medical device industry. (Pharma/biotech are acceptable).
- Experience with FDA 21 CFR 820 and ISO13485 regulations.
- Attention to detail and ability to follow directions in modifying the documentation
- Ability to interact and collaborate with multiple disciplines, and communicate clearly and effectively verbally and in writing
- Ability to work with minimal direction, and utilize good problem-solving skills
- Ability to multitask and work within a fast-paced dynamic team environment
- Bachelor’s Degree in a scientific field