Scientific Technical Writer
4 weeks ago
Job Summary:
We are seeking a highly skilled Scientific Technical Writer to join our team at Thermo Fisher Scientific. As a Scientific Technical Writer, you will play a critical role in assisting with the preparation of analytical method validation protocols and reports, method transfer protocols and reports, analytical methods, and specifications used by the Development Laboratory.
Key Responsibilities:
- Assist with the preparation of technical documents such as method validation and transfer protocols, reports, analytical methods, and specifications.
- Help to provide input on 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 carry out 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.
- Minimum 3 years' pharmaceutical laboratory work experience.
- Experience in the preparation of technical documents.
- Experience in laboratory testing and method validation.
Preferred Qualifications:
- 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.
Working Conditions:
The position requires ordinary ambulatory skills and physical coordination sufficient to move about the lab/lab office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time. Manipulation (lift, carry, move) of light to medium weights of 10-35 pounds. Arm, hand, and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
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