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Scientific Technical Writer
2 months ago
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 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.
- 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.
- 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.
- Equivalent combinations of education, training, and relevant work experience may be considered.
- 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), Chemstation, and OpenLab.
- Well-organized and detail-oriented.
- Excellent interpersonal and communication skills (both oral and written).
- Ability to work well independently and in a team environment with limited supervision.
- Ability to prioritize multiple tasks.
- Proficient in the English language.
- Follow all Environmental Health & Safety Policies and Procedures.
- Work collaboratively with fellow team members, modeling positive team principles and partnering to meet project and departmental objectives.
- Carry out all duties within strict compliance to Patheon quality systems SOPs and Good Manufacturing Practice (GMP).
- Maintain workspace in a clean and orderly fashion.
- Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow.
- Be client and patient conscious at all times.
- Understand Key Performance Indicators (KPIs) and strive to improve the performance of the team by identifying areas for system improvements and engaging in problem-solving.
- Model positive thinking and be open to change, motivating the team to adapt to shifts in priorities and new ways of working.
- Proactively identify areas for improvement in the execution of procedures.
- Communicate risks to timelines in a proactive manner.
- Consistently strive to improve skills and knowledge in related fields.
- Position requires ordinary ambulatory skills and physical coordination sufficient to move about 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.
