Quality Assurance Specialist I - RUO (ADX-242-20)
Quality Assurance Specialist I - RUO (ADX-242-20)
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, will support Research Use Only (RUO) processes by maintaining Quality System compliance in a regulated environment on a day-to-day basis.
RESPONSIBILITIES:
- Assigned as direct QA support to all operations of ArcherDX RUO assay components and processes.
- Support of RUO production-related activities including receipt, transfer, and release of raw materials, labeling verifications, kitting verifications, QC report reviews, COA reviews, etc.
- Provide QA support to other functional groups to create and maintain product-supporting processes in a controlled state to support business needs.
- Assist in maintenance of the e-QMS Document Control program for RUO Documentation.
- Assist in initiation and drafting of Deviation/Nonconformance Reports.
- Assist with continuous improvement across RUO Ops programs and work with end-users to implement.
- May assist with validation activities (IQ/OQ/PQ) of processes, methods, and equipment.
- May assist in managing RUO Equipment program, including installation and monitoring of maintenance and calibration.
- May assist with Product Investigations from Customer Feedback.
- May assist with Lean-initiative projects.
- Maintain compliance with all company policies, quality systems, and procedures.
- Perform other duties as assigned by supervisor.
QUALIFICATIONS:
- 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 desired.
- Attention to detail and ability to follow directions in modifying the documentation (utilizing Microsoft Office).
- Ability to utilize a multitude of electronic programs, such as E-QMS, ERP, MES, and other tools, as needed.
- 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
EDUCATION:
- Bachelor’s Degree in a scientific field