Technical Writer

7 Argonaut, Aliso Viejo, CA 92656, USA

Full-TimeDepends on ExperienceMid-LevelBachelors

Job Description

The successful applicant will work with writing validation plans and reports, document editing, formatting (text, tables, adherence to templates) and ensuring internal document consistency. Assist with creating, writing, editing and reviewing validation plans and validation reports in compliance with all regulatory requirements and in a paperless system with supervision. Assist with reviewing validation data, including preliminary data QC, organizing the data into the required formats and ensuring consistent style and language for regulatory compliance. Assist with developing and maintaining templates. Review and edit validation specific SOPs and WIs with supervision. Train template users. Assist with adhering to validation project timelines for timely completion of documents.

Where is this job?

This job is located at 7 Argonaut, Aliso Viejo, CA 92656, USA

Job Qualifications

Experience with technical writing or writing in a regulated environment.
emonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills
Experience with validation summary preparation for CE-IVD, PMDA or FDA leveraging the 510K and/or PMA pathways for diagnostic tests
Fluent in Japanese.

Required Skills

Documentation skills
Technical writing skills
Time Management Skills
Document writing
Regulatory writing
Validation summary preparation

Soft Skills

Process Improvement
Problem-Solving
Flexibility/Adaptability
Detail Oriented and Organized
Verbal and Written Communication
Multi tasker

Compensation

According to JobzMall, the average salary range for a Technical Writer in 7 Argonaut, Aliso Viejo, CA 92656, USA is approximately $60,000 to $90,000 per year. This salary range is determined by taking into account factors such as experience level, industry, and qualifications. Technical writers in this area may also receive additional compensation such as bonuses, health insurance, and other benefits.

Additional Information

Ambry Genetics is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedOctober 21st, 2021

Apply BeforeJune 21st, 2025

This job posting is from a verified source.

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