Ambry Genetics

Technical Writer: Validations (REMOTE, USA)


Pay$80000.00 - $95000.00 / year
LocationRemote
Employment typeFull-Time

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  • Job Description

      Req#: TECHN004238
      Employer Industry: Genetic Testing and Molecular Diagnostics

      Why consider this job opportunity:
      - Salary up to $95,000 per year
      - Eligibility for a Short-Term Incentive Plan with a target of 5% of annual earnings
      - Comprehensive benefits package including medical, dental, vision, FSA, paid sick leave, and generous PTO
      - Opportunity to work in a dynamic and innovative environment focused on genetics and human disease
      - Chance to collaborate with cross-functional teams and contribute to meaningful projects

      What to Expect (Job Responsibilities):
      - Create and manage documents associated with the development and validation of tests, ensuring compliance with design control
      - Collaborate with subject matter experts (SMEs) to populate, organize, and edit documentation for clarity and consistency
      - Assist in ensuring compliance with relevant regulatory requirements
      - Develop and maintain templates for controlled records and train users on their application
      - Represent the Technical Writers on core teams and support other assigned duties

      What is Required (Qualifications):
      - B.S./B.A. in molecular biology, genetics, or related field with 6+ years of post-graduate laboratory experience in document writing in a CLIA setting; M.S. with 4+ years; or Ph.D. with 2+ years
      - Experience with high complexity molecular testing technologies such as Next Generation Sequencing (NGS) and qPCR
      - Proven experience in documenting complex molecular testing processes
      - Strong analytical and problem-solving skills
      - Ability to work independently and collaborate effectively with remote and on-site teams

      How to Stand Out (Preferred Qualifications):
      - Familiarity with Clinical and Laboratory Standards Institute (CLSI) standards
      - Experience with regulatory writing for medical devices

      #GeneticTesting #MolecularDiagnostics #TechnicalWriting #RemoteWork #CareerOpportunity
  • About the company

      Ambry is committed to delivering accurate genetic test results for hereditary cancer. Request a sample kit today

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