Manufacturing Technical Writer

Category:

Life Science

Employment Type:

Direct Hire

Reference:

BH-381311

Yoh is hiring for a Manufacturing Technical Writer
for our Pharmaceutical client in Indianapolis, Indiana.

Industry: Pharmaceuticals
Location: Noblesville,IN

Position Summary

• Utilize technical writing strategies to ensure content of documentation is clear, concise, and complete.
• Author and revise technical documentation including facility and equipment SOPs, batch records, specifications, and training documents.
• Author and manage change controls as necessary to implement new procedures as well as revisions to documentation and SOPs to facilitate launch of new products.
• Participate in process and equipment testing to learn systems being documented.
• Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
• Coordinate with operations, R&D, and quality representatives to ensure all project documentation requirements are achieved.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor Degree or equivalent work experience required.
• 3 or more years of relevant experience required.
• Must be able to communicate clearly in English and have solid communication skills including grammar and composition.
• Demonstrated understanding of GMP / cGMP regulations.
• Skill in communication, written and verbal with the ability to interact with cross-functional teams.
• Proven time management skills and a strong attention to detail.
• Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
• Proficiency in computer skills and experience with Microsoft Word, PowerPoint, and Excel.