Quality Control Associate I (ADX-141-20)

| Greater Boulder Area | Hybrid
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Quality Control Associate I (ADX-141-20)

 

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:

 

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 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).

 

RESPONSIBILITIES:

  • Execution of work instructions testing in-process raw, sub-assembly, and top-level materials
  • 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.

 

EXPERIENCE:

  • 2 or more years of experience in a laboratory setting utilizing micro-pipettes a plus

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-starterDriven to perform
  • Self-directed: needs little explicit direction
  • Able to organize, prioritize, and delegate tasks to efficiently move projects forward.

EDUCATION:

  • Bachelor's degree in science-related field required

 

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Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

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