NGS Laboratory Technologist (ADX-23-21) at ArcherDX
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.
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
- Execution of method validation and stability testing protocols
- Troubleshooting and critical analysis of data, equipment, and instrumentation ensuring compliance with standards and specifications
- Generation and peer review of data reports
- Drafting and updating standard operating procedures (SOP) and work instructions (WI)
- Maintenance of laboratory material stocks and initiation of re-orders
- Maintenance of laboratory equipment and instrumentation
- 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
- Upkeep of personal training and associated records
- Adherence to safety and quality laboratory standards
- 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.
- 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
- Flexibility to work nights and weekends as needed to meet critical business needs
- Strong communication and presentation skills
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
- Level I: 1 - 3 years of experience in a clinical or GMP laboratory setting
- Level II: 3 - 5 or more years of experience in a clinical or GMP laboratory setting
- Level III: 6+ years experience in a clinical or GMP laboratory setting
- Experience utilizing general laboratory equipment, such as micro-pipettes, qPCR instrumentation, thermal cyclers, BioAnalyzers, and Sequencers
- Experience with next-generation sequencing and Illumina instrumentation
- Bachelor’s degree in a science-related field required