Quality Assurance Technical Writer

Location: Buena, NJ

Job Summary:

The Quality Assurance Technical Writer will work with all departments in preparing document for review such as SOP’s or BPP’s.  Should understand the pharmaceutical industry manufacturing process.  Writing documents for investigations and or validations and other quality systems technical writing projects.

Essential Responsibilities:

  • Responsible for writing of Standard Operating Procedures (SOP).
  • Writing of Business Process Procedures (BPP)
  • Assist in writing investigations, by working with the personnel in the laboratory or manufacturing floor to understand the issues at hand, collect and summarize data and assist in drafting investigations and other technical writing projects.
  • Assist in technical writing projects to support other quality systems including CAPA, change control, audits and annual product reviews as needed.
  • Assist in maintaining physical and electronic documentation archives and repositories.

Qualifications:

  • Computer knowledge of Microsoft Office required.
  • Desired experience with systems such as SAP, LIMS, and QMS systems.
  • Minimally 2 pharmaceutical experience.
  • Desired familiarity with risk assessment for products and processes.

Physical Demands:

  • While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, and color vision.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

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