What are the responsibilities and job description for the Harba Solutions Inc. is hiring: Technical Writer in Indianapolis position at Harba Solutions Inc.?
Job Responsibilities :
- Create clear, concise, and comprehensive technical documentation.
- Develop and update facility and equipment SOPs, batch records, specifications, and training materials.
- Author and manage change controls to introduce or revise procedures, ensuring seamless product launches.
- Participate in process and equipment testing to gain system expertise.
- Address deviations, CAPAs, change controls, and document revisions to meet quality system standards and deadlines.
- Collaborate with operations, R&D, and quality teams to fulfill project documentation requirements.
- Ensure compliance with regulatory standards, including FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, and cGMP guidelines.
Qualifications :
