Document Reviewer I - QA

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Whitby, ON, CAN
In-Office
Biotech
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
The Role

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Summary:  

Responsible for reviewing all data, lab notebooks, and completed Certificates of Analysis (C of A) and Stability reports generated in the Laboratory. Verify and confirm the integrity and traceability of all data generated and reported. 

 

Essential Functions:   

  • Review all regular technical documents (e.g., batch testing, stability testing, method development and validation, raw materials and packaging components) and raw data generated in the Laboratory with high quality and deliver within standard time 

  • Ensure the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists/chemists.  

  • Verify the integrity and traceability of all data generated and reported.  

  • Follow up with scientist/chemists to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices’ standards.  

  • Notify department supervisor/manager regarding omissions, incomplete testing results or other irregularities.  

  • Write/Update SOPs and initiate change control when necessary. 

  • Adhere to assigned schedules and standard times. 

  • Maintain a safe working environment and report potential hazards.  

  • Perform alternating or rotating shift work (as required).  

REQUIRED QUALIFICATIONS 

 

Education:  

Bachelor of Science in Chemistry or related science. 

  
Experience:  

Minimum 2 years of previous pharmaceutical analytical development experience. 

 
Equivalency:  

Equivalent combinations of education, training, and relevant work experience may be considered.  

 

Knowledge, Skills and Abilities: 

Basic understanding the common analytical technologies (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV) spectroscopy, and titration. Knowledge in Empower, LIMS Nugensis and Trackwise software.    Excellent written and oral communication skillsGood working knowledge of Good Manufacturing Practices, International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA) requirementsStrong organizational skills and detail oriented. Ability to meet deadlines and prioritize. Demonstrated computer proficiency with Microsoft Office programsProficiency with the English Language. 

 

Standards and Expectations:   

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality 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 (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is 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 strives to improve skills and knowledge in related field.    

 

Physical Requirements:  

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor areaThere may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally. 

 

Disclaimer:   

This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as a comprehensive statement of work, responsibilities, or requirementsManagers and supervisors may assign other duties as needed. 

 

Nothing contained herein should be construed to create an employment contractOccasionally, required skills/experiences for jobs are expressed in brief termsAny language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 

 

Please note: Shift expectation is that 20 - 30% is occasional midnight shift.

 

 

 

 

 

Thermo Fisher Scientific Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Thermo Fisher Scientific and has not been reviewed or approved by Thermo Fisher Scientific.

  • Retirement Support Retirement programs include a strong company 401(k) match and an employee stock purchase plan that add meaningful long‑term value. Feedback suggests these features stand out among core financial benefits even when base pay feels average.
  • Healthcare Strength Health coverage offers multiple national medical options alongside dental and vision, with company‑paid life and disability coverage. This breadth is considered a solid foundation even if some costs may not be the lowest among peers.
  • Parental & Family Support Paid parental and caregiver leave, backup care, adoption assistance, and specialized family resources are available. Feedback suggests these supports are a notable plus for colleagues managing family and caregiving needs.

Thermo Fisher Scientific Insights

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The Company
HQ: Waltham, MA
100,000 Employees

What We Do

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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, Patheon and PPD.

Why Work With Us

You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.

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