QA Specialist II (ADX-300-20)

| Greater Boulder Area | Hybrid
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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

 

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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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