QA Specialist II (ADX-300-20)
QA Specialist II (ADX-300-20)
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 in one or more quality system area(s) of Documentation Control, Supplier Quality, Manufacturing, CAPA, Complaints or Design Quality Assurance.
RESPONSIBILITIES:
Job performance will involve a variety of activities including:
- Provide support to create and/or process quality system documentation.
- Process customer complaints.
- Assist with supplier approval process.
- Manage equipment including scheduling of maintenance and calibration.
- Perform audits and manage an audit schedule under the guidance of a senior level Quality Assurance employee.
- Assist with the management of Complaints, Nonconformance reports, Corrective and Preventative Actions reports
- Manage the document archiving and retrieving process.
- Assist or lead problem solving activities.
- 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, quality systems, procedures and ISO and GMP requirements.
- Ability to work with cross functional teams in problem solving.
- Assist in collecting and evaluating data to support quality metrics.
- 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.
EXPERIENCE:
- Five (5) years experience in the healthcare and/or regulated industry.
- Previous experience in Quality Assurance or Clinical Practices 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 or 7+ years experience in regulated environment