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Technical Writer II

2 months ago

Whitby, Canada Thermo Fisher Scientific Full time
Job Summary

We are seeking a highly skilled Technical Writer II - Operations Specialist to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will be responsible for creating and revising Standard Operating Procedures (SOPs) to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements.

Key Responsibilities
  • Develop and maintain SOPs for the operations department, ensuring they are accurate, clear, and up-to-date.
  • Collaborate with cross-functional teams, including compliance, quality, and technical operations, to ensure SOPs are aligned with business needs.
  • Conduct regular reviews and updates of SOPs to reflect changes in processes, procedures, and regulatory requirements.
  • Work closely with production management to ensure SOPs are implemented effectively and efficiently.
  • Develop and maintain training materials and programs to support SOP implementation.
  • Track and report on SOP status, training, and other related activities.
  • Identify opportunities for process improvements and implement changes to enhance efficiency and effectiveness.
Requirements
  • Bachelor's degree in a related field, such as pharmaceutical manufacturing, science, or a related field.
  • 2+ years of experience in a pharmaceutical manufacturing environment, preferably in a technical writing or operations role.
  • Strong knowledge of GMP requirements and pharmaceutical processing regulations.
  • Excellent written and verbal communication skills, with the ability to develop clear and concise documentation.
  • Strong organizational and time management skills, with the ability to prioritize multiple tasks and meet deadlines.
  • Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
Preferred Qualifications
  • Experience leading training programs in the pharmaceutical industry.
  • Knowledge of quality management systems and regulatory requirements.
  • Ability to work in a fast-paced environment and adapt to changing priorities.
Working Conditions

This is a full-time position that requires ordinary ambulatory skills and physical coordination. The position involves standing, walking, stooping, kneeling, and crouching for prolonged periods of time. The ability to lift, carry, and move light to medium weights (10-35 pounds) is also required. Visual acuity is necessary for using a keyboard, computer monitor, and operating equipment. Safety glasses, safety shoes, lab coat, and other personal protective equipment may be required.