Technical Writer

$68,640 - $72,800/Yr

Day & Zimmermann - Noblesville, IN

Full-time

Noblesville, IN

Fabricated Metal Product Manufacturing

About the position

Yoh is hiring a Technical Writer for our Pharmaceutical partner in Indianapolis, Indiana. In the Technical Writer position, you will be focused on technical documentation including facility and equipment SOPs, batch records, specifications, and training documents. This individual should be well versed in operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, USP, cGMP, etc.). The opportunity will only be open to candidates who are willing to go onsite and work within a team environment. 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.).

Responsibilities

• 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 and revisions to documentation and SOPs.
• 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.
• Maintain operational compliance with US and international regulatory agencies and guidelines.

Requirements

• Bachelor's 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.
• Experience in technical documentation including facility and equipment SOPs, batch records, specifications, and training documents.
• 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.