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Technical Writer - Operations
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| Department: |
Technical Services
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| Job Description: |
Responsible for developing, writing and editing technical documentation while ensuring compliance with applicable regulatory requirements. Works on assignments that are complex in nature where analysis of situations or data requires an in depth evaluation of various factors.
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| Duties/Responsibilities: |
Essential Functions
Create new or revise existing content for SOPs and validation documents with a high degree of quality in accordance with cGMP requirements and corporate guidelines.
Assist with validation documentation (i.e. IQ/OQ/PQ protocols and reports)
Recommends process improvements to shorten processing times and improve quality of documentation.
Works collaboratively with a project team member including manufacturing, packaging, warehouse, shipping, maintenance and other subject matter experts to solidify content.
Reading existing documentation and other material to become familiar with current and desired future processes.
Adheres to Good Documentation Practices (GDPs).
Good attention to detail and the ability to communicate well with others is required.
Ability to explain complex concepts with clarity and simplicity.
Additional Job Functions
Perform other duties as assigned or needed.
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| Qualifications: |
Qualifications/Knowledge, Skills, & Abilities Requirements
Exceptional written and oral communication skills.
Ability to apply appropriate statistical analysis to a variety of data sets.
Technical writing experience in an FDA regulated industry preferred.
Ability to work independently as well as in a team environment.
Bachelors degree or equivalent work experience required.
Experience with Electronic Document Management Systems preferred.
Possess organizational and time management skills with the ability to multitask and work towards multiple priorities and goals.
Ability to efficiently and effectively perform all essential position duties and responsibilities with or without reasonable accommodation without posing a direct safety threat to others or self.
Pharmaceutical or Nutriceutical industry experience preferred.
Knowledge of CFR Regulations preferred.
Strong knowledge of current Good Manufacturing Practice (FDA, EU and ICH) requirements and Quality Systems.
Typical Physical Requirements
Frequently involves light work: Exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently and/or a negligible amount of force constantly to move objects.
Involves a variety of physical activities including:
Stooping Standing Grasping Feeling Talking
Visual acuity required is the minimum standard for use with those whose work deals largely with preparing and analyzing data and figures, accounting, transcription, computer terminals, extensive reading, visual inspection involving small defects, handling small parts, operation of simple machines, using measurement devices, assembling or fabrication of parts at distances close to the eyes.
Machines Typically Operated
Computer, telephone, and other equipment as needed.
Typical Environmental Conditions
The worker is not substantially exposed to adverse environmental conditions. This is a typical office or administrative environment.
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| Salary Range*: |
US Grade 10
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| Location: |
Salt Lake City
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| Posting Date: |
06/14/2012
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Open Until Filled
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| Contact: |
hrusana@usana.com
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| *Salary Disclaimer - The salary listed is a minimum
only or refers
to an internal grade. Final salary is commensurate with related skills, education, experience
and
abilities and will be determined in the interview. |
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