Technical Writer

  • location: San Diego, CA
  • type: Contract
  • salary: $53 - $58 per hour

job description

Technical Writer

job summary:
Job Description:

Roles & Responsibilities:

- Develop Change strategy, write and execute test cases & test plans

- Support testers by providing guidance on scripts during Software validation execution.

- Analyze production processes and document business needs with user requirements

- Communicate stakeholder needs by translating business requirements into software requirements

- Clearly communicate analyzed gaps in process or documentation to document owners.

- Participate in requirements gathering and provide sound feedback.

- Manage, Control & review OQ/PQ documentation and ensure OQ/PQ documents are as per company's document standards.

- Ensure the content in Change Records are clear to stand as evidence for any audit requirements.

Job Skills:

- Must have good attention to detail and ability to adhere to protocol, revenant SOPs/WI and supporting documentation.

- Extensive validation experience in 21 CFR Part 11.

- Expertise in following GxP standards, Data Integrity and Good Documentation Practices.

- Proficiency with core computer software/systems (Word, Excel, Project, SharePoint, etc.).

- Good communication skills and English fluency both written and verbal.

- Change Management experience (functional, usability, regression, performance, exploratory).

- Good written and verbal communication skills.

- Ability to work independently with minimal direction.

- Identify areas for process improvement

- LIMS/ELN specific experience a plus

- ValGenesis experience a plus

 
location: San Diego, California
job type: Contract
salary: $53 - 58 per hour
work hours: 8am to 4pm
education: Bachelors
 
responsibilities:
Roles & Responsibilities:

- Develop Change strategy, write and execute test cases & test plans

- Support testers by providing guidance on scripts during Software validation execution.

- Analyze production processes and document business needs with user requirements

- Communicate stakeholder needs by translating business requirements into software requirements

- Clearly communicate analyzed gaps in process or documentation to document owners.

- Participate in requirements gathering and provide sound feedback.

- Manage, Control & review OQ/PQ documentation and ensure OQ/PQ documents are as per company's document standards.

- Ensure the content in Change Records are clear to stand as evidence for any audit requirements.

 
qualifications:
  • Experience level: Experienced
  • Minimum 4 years of experience
  • Education: Bachelors
 
skills:
  • Experience level: Experienced
  • Minimum 4 years of experience
  • Education: Bachelors

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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