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).
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
Create procedural document templates with standardized formatting
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.
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