Quality Control Intern (ADX-65-20)
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.
Evaluates and implements protocols and methods to inspect and test in-process raw materials and finished products and ensure that they are in compliance with an internal and external safety, quality and regulatory standards requirements for distribution. Performs analysis and identifies trends in the inspection of finished products, in-process materials, and bulk raw materials, and recommends corrective actions when necessary. Develops processes and tests to determine that appropriate quality control analysis is being performed. Prepares documentation for inspection and testing procedures. Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records. May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO).
Job performance will involve a variety of activities including:
- Job performance will involve a variety of activities including:
- Execution of work instructions testing in-process raw, sub-assembly, and top-level materials
- QC Associate
- Critical analysis of data ensuring compliance with standards
- Generation of data reports and release of materials
- 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 validation protocols
- Identification of non-conforming material and subsequent report initiation and generation
- 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.
- 2 or more years of experience in a laboratory setting utilizing micro-pipettes a plus
- Junior Undergraduate
- Bio Chem/ Chem Engineer preferred
POSITION TYPE/EXPECTED HOURS OF WORK:
- This is a part-time position working evening business hours. This position may require the flexibility to work diverse schedules, such as weekends and holidays.
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