To Apply for this Job Click Here

The Contract Manufacturing Technical Writer will work in a dynamic organization in North America. This role has the responsibility for supporting projects related to client's business strategy in the space of sterile drug manufacturing including reactor and cyclotron derived new products. This is an on-site role 100% of the time in Noblesville, IN.

Essential Functions

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.).

Requirements

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.Ability to work well with others and independently.Able to read, understand and follow work instructions in a safe, accurate and timely manner. Proficiency in computer skills and experience with Microsoft Word, PowerPoint, and Excel. 1402368_1736174979 To Apply for this Job Click Here