Job Title: Technical Writer
Location: Morrisville, North Carolina (On-site)
Job Summary: We are seeking a specialized professional to join our team to deliver expert written documentation for clinical and commercial manufacturing campaigns. Our team values strong technical acumen and the ability to support investigations and project implementation within a collaborative, cross-functional environment.
Responsibilities:
- Develop clear and concise written documentation, including protocols, reports, and filing sections, to support manufacturing sciences activities.
- Lead investigations and provide documentation expertise for project implementations related to fill/finish, visual inspection, and packaging operations.
- Perform data verification activities and create source documentation critical for the confirmation of report data.
- Create and maintain the Master Sample Matrix (MSM) to support production floor activities for manufacturing personnel.
Required:
- Background in Life Sciences with at least 5 years of relevant experience (preferred).
- Strong communication and project management skills that suit leadership of tech transfer projects.
- Working knowledge and technical understanding of Parenteral Filling Operations, including equipment such as Filling Isolators, Lyophilizers, and Visual Inspection systems, and processes for transferring operations into full-scale manufacturing facilities.
- Ability to work in a team environment, analyze scientific datasets, and produce excellent written documentation with some knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, and Continued Process Verification.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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