Technical Writer - Validations-Remote, USA

Compensation: $90,000 - $95,000 per year. You are eligible to a Short-Term Incentive Plan with the target at 5% of your annual earnings, terms and conditions apply.    Technical Writer - Validations-Remote USA    The Technical Writer is responsible for working with documents associated with the development and validation of new and updated tests at Ambry Genetics. These documents include product and technical specifications, development and validation plans and reports, and controlled documents (SOPs and WIs). All documents are created in compliance with design control in an electronic document management system. This position is highly cross functional across multiple teams and departments and requires the ability to work collaboratively in a fast-paced environment to successfully deliver completed documents.   Essential Functions  

• Become proficient with the paperless document control system including all aspects of document creation, review and approvals.
• Work with subject matter experts (SMEs) on all aspects of documentation including but not limited to: populating text, organizing data, and editing for clarity, consistent style and language.
• Assist with ensuring compliance with applicable regulatory requirements.
• Work with SMEs for timely completion of documents
• Assist with the development and maintenance of templates for controlled records.
• Train and assist template users.
• Work across multiple teams to ensure consistent application of the process.
• Represent the Technical Writers on core teams as assigned.
• Other duties as assigned.

Qualifications 

• B.S./B.A in molecular biology, genetics or related field with 6+ years post-graduate laboratory experience in document writing in a CLIA setting or M.S. in molecular biology, genetics or related field with 4+ years post-graduate laboratory experience in document writing in a CLIA setting, or Ph.D. in molecular biology, genetics or related field with 2+ years post-graduate laboratory experience in document writing in a CLIA setting or equivalent experience
• Experience with high complexity molecular testing technologies including Next Generation Sequencing (NGS), deletion/duplication analysis, Sanger sequencing, or qPCR.
• Experience with documenting high complexity molecular testing technologies.
• Demonstrated analytical and problem-solving skills
• Work very well independently, be able to collaborate and communicate with cross-functional team members both remote and on-site

  Preferred

• Familiarity with Clinical and Laboratory Standards Institute (CLSI) standards
• Experience with regulatory writing for medical devices

 

About Us:

Ambry Genetics Corporation is a CAP-accredited and CLIA-licensed molecular genetics laboratory based in Aliso Viejo, California. We are a genetics-based healthcare company that is dedicated to open scientific exchange so we can work together to understand and treat all human disease faster.

 

At Ambry, everyone is welcome. A career at Ambry Genetics is a chance to be part of a dynamic company that aims to improve health by understanding the relationships between genetics and human disease. We earned our reputation as industry leaders by responsibly introducing cutting-edge genetic testing solutions and continually sharing what we learn with the global scientific community.

 

At Ambry you will be learning, challenging yourself, and having fun while collaborating with teammates through the open exchange of ideas.  Our outstanding benefits program includes medical, dental, vision, 401k, FSA, paid sick leave and generous paid time off (PTO) program. The Company reserves the right to make changes to the 401k plan from time to time. You can learn more about the benefits here. Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drug-free work environment.

 

The Company believes in second chance employment.  Qualified applicants with arrest or conviction history will be considered regardless of their arrest or conviction history, consistent with local laws such as Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.  You do not need to disclose your criminal history or participate in a background