Scientific Technical Writer
5 days ago
Job Summary:
We are seeking a highly skilled Scientific Technical Writer to join our team at Thermo Fisher Scientific. This is an exciting opportunity for a detail-oriented and organized individual to work with our Development Laboratory, preparing analytical method validation protocols and reports, method transfer protocols and reports, analytical methods, and specifications that meet current regulatory, corporate, and industry standards.
About the Role:
- Assist in the preparation of technical documents such as method validation and transfer protocols, reports, analytical methods, and specifications.
- Contribute to the generation of method transfer plans for incoming projects.
- Document all experimental data in accordance with ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) principles.
- Independently perform HPLC, dissolution, GC, and physical testing analysis following established procedures and Analytical Methods & Standard Operating Procedures (SOPs).
- Work proficiently with Empower, NuGenesis, MS Word, and Excel software.
- Recognize and report unexpected or Out Of Specification (OOS) results immediately to the supervisor and conduct laboratory investigations under direction.
- Maintain a safe working environment and report potential hazards.
- Perform alternating or rotating shift work as required.
Requirements:
- Bachelor of Science degree in Chemistry or a related science field.
- Minimum 3 years' experience in pharmaceutical laboratory work.
- Experience in preparation of technical documents.
- Experience in laboratory testing and method validation.
About You:
- Strong knowledge of analytical method validation requirements.
- Excellent Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH), and United States Food and Drug Administration (FDA) compliance knowledge.
- Knowledge of regulatory requirements including USP/NF and Ph. Eur.
- Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint) and Chemstation and OpenLab.
- Well-organized and detail-oriented.
- Excellent interpersonal and communication skills (both oral and written).
- Able to work well independently and in a team environment with limited supervision.
- Able to prioritize multiple tasks.
- Proficient in the English language.
Compensation Package:
The estimated salary for this role is $65,000-$85,000 per year, depending on location and experience. Additionally, Thermo Fisher Scientific offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
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