Quality Assurance Specialist III (ADX-238-20)
Quality Assurance Specialist III (ADX-238-20)
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 II will provide support primarily Complaints Management, and as needed, Supplier Quality, CAPA, or Non-Conformance Management.
RESPONSIBILITIES:
- Process customer complaints from intake, through investigation to complaints closure.
- Maintain a current and accurate complaints log.
- Manage lead time requirements for reporting and complaints closures by using KPIs and notifying stakeholders of complaints risking to be late.
- Facilitate the regular ARC, Archer Complaints board.
- Interact with quality engineers for safety, hazard and risk analyses, as well as for trending for larger continuous improvement opportunities.
- Interact with regulatory affairs for reportability.
- Interact with FAS and Clinical Operations for communications regarding the respective complaints.
- Interact with respective functions to facilitate complaints investigations.
- Perform audits in support of internal audits or supplier quality as needed.
- Assist with the management of Nonconformance reports, Corrective and Preventive Actions reports.
- Assist or lead problem solving activities.
- Identify improvements by analyzing the current business/system processes and recommending improvements within the scope of respective focus area(s)
- Maintain compliance with all company policies, quality systems, procedures and ISO and GMP requirements.
- Collaborate, working with cross functional teams in investigations and problem solving.
- Assist in collecting and evaluating data to support quality metrics.
- Review, understand, and be compliant to ArcherDX HIPAA Security policies and procedures.
- Safeguard the privacy and security of protected health information and European Union personal data.
- Process and handle European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
- Perform other duties as assigned by supervisor.
EXPERIENCE:
- Five (5) years experience in a regulated industry.
- Previous experience in Quality Assurance 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.
KEY ATTRIBUTES:
- Attention to detail with an ability to follow directions in modifying documentation.
- 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.
- Ability to multitask and work within a fast-paced dynamic team environment.
EDUCATION:
- Bachelor’s Degree in BioChemistry, Engineering or equivalent, or 7+ years experience in regulated environment