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Technical Writer

Louisville, Kentucky
Technical Writer

This position is open for a Technical Writer with a minimum of 5 years of experience in the pharmaceutical industry.  The candidate must have solid GMP and regulatory experience and will be responsible for providing support in assessment, improvement, standardization and/or creation of SOPs.

Duties and Responsibilities
  • SOPs: Consolidate redundant information, change, improve and create new ones.
  • Work with cross site personnel in teams to understand/make recommendation on network SOP’s.
  • Participate in meetings to understand procedures, resolve problems, address issues and develop new strategies.
  • Gathering data and compile documentation.
  • Participate in brainstorming sessions to identify root causes of gaps/observations and corrective actions.
  • Lead/support requirements for compiling documentation for evidence binders. Manage multiple priorities.
  • Communicate with the staff and management on ways of implementing plans and recommendations.
  • Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement Validation standards on a daily basis.
Skills and Specifications
  • Good problem solvers.
  • Be able to sense needs when they arise.
  • Be organized.
  • Keep an eye for detail.
  • Willing to work overtime including weekend depending on the nature of work available.
  • Able to work with minimum or no supervision
  • Strong interpersonal skills and must work in a team
  • Fully Bilingual (English and Spanish)

Bachelors of Science in  Science or Engineering.
Ultimate Solutions Corp is an Equal Opportunity Employer.
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