Quality Control Associate I/II/III, IVD (ADX-170-20)
Quality Control Associate II/III, IVD (ADX-170-20)
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:
Executes test methods to evaluate quality, functionality and stability of raw materials, in-process materials and finished products to ensure that they are in compliance with specifications for use in Good Manufacturing Practice (GMP) applications for In-Vitro Diagnostics (IVD). Tracks and identifies trends in QC data and recommends corrective actions when necessary. Assists in method transfer, method validation and method troubleshooting activities. Conducts out-of-specification (OOS)/ out-of-trend (OOT) investigations as needed. Lead and support process improvement projects within all QC laboratories ensuring harmonization between the three labs. This position reports to the QC Supervisor, IVD.
RESPONSIBILITIES:
Job performance will involve a variety of activities including:
- Execution of work instructions for testing raw materials, in-process materials/sub-assemblies, and top-level IVD materials to determine compliance to specifications
- Critical analysis of data ensuring compliance with standards and specifications
- Generation of data reports
- Adherence to safety and quality laboratory standards
- Upkeep of personal training and associated records
- Maintenance of laboratory material stocks and initiation of re-orders
- Execution of method validation and stability testing protocols
- Identification of non-conforming material and subsequent report initiation and generation (OOS/OOT investigation)
- This position may cross-train in the RUO (Research Use Only) and PCM (Personal Cancer Monitoring) QC laboratories
- Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
KEY ATTRIBUTES:
- Drive and determination
- Ability to work in a fast-paced and dynamic environment
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company
- Strong communication and presentation skills
- Self-starter
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
EXPERIENCE:
- Level I: 1-3 years of experience in a GMP laboratory setting
- Level II: 3 - 5 or more years of experience in a GMP laboratory setting
- Level III: 6+ years experience in a GMP laboratory setting
- Experience utilizing micro-pipettes and PCR
- Experience in working with oligonucleotides and/or lyophilized products preferred
- Experience working with in-vitro diagnostics and/or next generation sequencing preferred
EDUCATION:
- Bachelor’s degree in a science-related field required