Technical Writer
G & W Labs - South Plainfield, NJ

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Technical Writer

Position Purpose:

This position is responsible for working with subject matter experts in Quality Control, Analytical Research and Development, Technical Services and Quality Assurance to write, review, approve, and maintain pharmaceutical GMP documentation (procedural documents, specifications, analytical methods, work practices, templates, and forms).

Principal Accountabilities:

Plan, develop, and author analytical specifications, analytical methods, standard operating procedures, templates, and forms in a GMP setting.

Perform documentation gap analyses and develop plan for writing requirements.

Create procedural document templates with standardized formatting and styles.

Research FDA and USP regulations to develop best practices and ensure documents are current and compliant.

Review USP and Pharmacopeia!Forum for any updates to G&W Products and issue summary report.

Work with subject matter experts in Quality Control, Analytical Research and Development, Technical Services, and Quality Systems to develop process maps, procedural documents, work practices, templates and forms.

Proofread and edit procedural documents written by others.

Assist in maintenance of an electronic document management system.

Required Skills:

Experience with application and use of Word, Excel, Visio and Project

Experience with document control/management in a regulated environment

Experience using electronic document management system

In-depth understanding of good documentation practices in a GMP environment

Strong working knowledge of editing, proofreading, English spelling, grammar and punctuation

Skilled at organizing information into a clear concise written form

Fundamental knowledge of quality systems in regulated environments

Customer focused, initiative, interdependent partnering

Good organizational and planning skills

Education and Experience:

A Bachelor's Degree in a scientific discipline and 3-5 years of proven experience writing standard operating procedures and work procedures.

Experience in biologics, pharmaceutical or medical device environment