Sr. Technical Writing Specialist
1901 East Alton Avenue Santa Ana, CA 92705
- Develop and create accurate CMS/DITA specialized technical documents.
- Provide technical writing expertise to create complex design control documentation packages including process validation documents (e.g, Installation Qualification, Operations Qualification, Process Qualification) CMS/DITA specialized protocols and reports, technical summaries, and test procedures.
- Collaborate with stakeholders (e.g, production employees, technicians, engineers, project teams, regulatory teams and management) to develop an understanding of the product, component, or device changes.
- Maintain documentation in a standard format following established guidelines.
- Review documents for style, clarity, grammar, and punctuation.
Required Skills / Education / Experience
- Bachelor' s degree in related field required.
- 5 years of technical writing experience required.
- Experience with CMS/DITA documentation processes HIGHLY preferred.
- Experience in the biotechnology industry (e.g., Quality Assurance, Regulatory) preferred.
- Proven expertise in Microsoft Office Suite including Word, Excel, PowerPoint, and Publisher; Adobe and Photoshop preferred.
- Excellent editing and proofreading skills.
- Excellent written and verbal communication skills in English including negotiating and relationship management skills.
- Excellent problem-solving and critical thinking skills.
- Full knowledge and understanding of policies, procedures and guidelines relevant in the development of technical documentation.