Technical Writer - Life Science
$124,800–$124,800 year
On-site · Research Triangle Park, North Carolina, United States
Research Triangle Park, North Carolina, United StatesOn-siteContract$124,800–$124,800 yearMid LevelNot SpecifiedServicesUnknown
Type
Contract
Level
Mid Level
Education
Not Specified
Company size
Unknown
Industry
Services
Job Summary
Technical Writer in Manufacturing Sciences at RTP Pharma Site to provide written documentation expertise for clinical and commercial manufacturing campaigns. Lead investigations and project implementation for fill/finish, visual inspection, and packaging; write PPQ Protocols and PPQ Reports; perform data verification for reports; draft sections of filings; create the Master Sample Matrix (MSM) for on-the-floor activities.
Required Qualifications
- Life Science background with at least 5 years’ experience
- Good communication and project management skills appropriate for leadership of tech transfer projects
- Working knowledge in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities
- Excels at working in a team environment
- Comfortable analyzing scientific datasets/analytical skills with excellent written skills
- Ability to work independently and support a large cross-functional group
- Some knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.