Create new or revise existing content for regulatory
documentation in accordance with industry best practices, cGMP
requirements and corporate guidelines. Work collaboratively with
project team members including Manufacturing, Engineering, Process
Development, Quality and other subject-matter experts to solidify
MAJOR DUTIES AND RESPONSIBILITIES:
Creation of Batch records, SOPs, change requests, process
validation protocols and equipment qualification protocols.
Review current documentation and recommend revisions or changes
in scope, format, content, and methodology.
Edit, standardize, or make changes to material prepared by other
writers or establishment personnel.
Organize material and complete writing assignment according to
set standards regarding order, clarity, conciseness, style, and
Understand different user levels and write documents that meet
the need of the end user.
On new projects, provide updates on document deliverables to
project management and ensure that documents are delivered to the
customer (either internal or external) in a timely manner.
Performing other duties as assigned.
Required (Experience in cGMP environment is preferred. The
ability to communicate well with others through speech and prose is
an absolute requirement. The technical writer must also be able to
process complex thoughts and communicate them efficiently to the
end user. Must be able to work independently as well as in a team
Preferred Additional: Good command of MS Office Suite (Word,
Excel, PowerPoint, and Outlook). Strong working knowledge of
editing, proofreading, spelling, grammar, and punctuation. Bachelor
Degree in Science preferred.
Proficient with use of Microsoft Office Suite (Word, Excel,
PowerPoint, and Outlook)
Education and/or Training
Any related GDP and GMP training. B.S. Degree Preferred; High
School Diploma or equivalent required.