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Documentation Reviewer I - Jobs in Mississauga, ON

Thermo Fisher Scientific
Job LocationMississauga, ON
EducationNot Mentioned
SalaryNot Disclosed
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeFull Time

Job Description

Document Reviewer IThis role requires flexibility to work in the afternoon shifts.How will you make an impactThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 90,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.What will you doResponsible for independently reviewing various technical reports and raw data generated in Lab Operations.Responsibilities:

  • Reviews with minimum supervision all regular technical documents (e.g., batch testing, stability testing and method validation) and raw data generated in the Laboratories with high quality and deliver within the agreed schedule.
  • Ensures the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists/chemists.
  • Verifies the integrity and traceability of all data generated and reported.
  • Follows up with scientists/chemists/technicians to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices’ standard.
  • Notifies department supervisor/manager regarding omissions, incomplete testing results or other irregularities.
  • May be required to travel to different sites depending on business requirements (as required)
  • It may be essential to perform alternating or rotating shift work (as required)
How will you get thereRequirementsEducation:Bachelor of Science in Chemistry or related science.Experience:
  • Minimum 1 year of previous pharmaceutical analytical development experience.
  • Previous document reviewer experience preferred.
  • Familiar with current ALCOA principles.
Knowledge, Skills and Abilities:
  • Basic understanding of the common analytical technologies (e.g., High-Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV) spectroscopy, titration, and raw material testing.
  • Good written and oral communication skills.
  • Understanding of Good Manufacturing Practices, International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA) requirements.
  • Should have GMP chromatography experience (Specifically EMPOWER is an asset).
  • Direct pharmaceutical experience in a GMP environment.
  • Strong organizational skills and detail-oriented.
  • Ability to meet deadlines and prioritize.
  • Demonstrated computer proficiency with Microsoft Office programs.
  • Proficiency with the English Language.
At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.Quick Apply
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