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Documentation Reviewer 1 (12 month fixed contract)

Thermo Fisher

Documentation Reviewer 1 (12 month fixed contract)

Thermo Fisher

Mississauga, Canada

·

On-site

·

Contract

·

5d ago

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Office

Job Description

Summary

Responsible for independently reviewing pharmaceutical laboratory documentation, raw data, and analytical reports generated in Lab Operations. The candidate must be familiar with pharmaceutical laboratory analysis and GMP requirements.

This is a 12 month fixed contract position. The working hours are M-F 1:00pm-9:30pm.

Essential Functions

  • Review, with minimal supervision, routine pharmaceutical laboratory technical documents (e.g., batch testing, stability testing, and method validation) and associated raw data generated in Pharmaceutical Laboratories, ensuring high quality and delivery within agreed timelines.
  • Ensure lab test methods, protocols, and Standard Operating Procedures (SOPs) are properly followed by laboratory chemists.
  • Demonstrate familiarity with pharmaceutical laboratory analytical systems and equipment such as Empower software, LIMS, HPLC, UV, pH meters, etc.
  • Verify the integrity, accuracy, and traceability of all data generated and reported by laboratory chemists.
  • Follow up with laboratory chemists to ensure all required corrections are addressed in compliance with Good Manufacturing Practice (GMP) standards.
  • Notify the department supervisor of omissions, incomplete testing results, or other irregularities.
  • Maintain a safe working environment and report potential hazards.
  • Perform afternoon shift work, as required by business needs
  • Travel to different sites as required by business needs.

Required Qualifications

Education:Bachelor of Science in Chemistry or a related scientific discipline.

Experience:1–3 years of pharmaceutical analytical laboratory experience.

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

Knowledge, Skills, and Abilities

  • Familiarity with laboratory analytical technologies, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectroscopy, titration, and raw material testing.
  • GMP chromatography experience, specifically with Empower software.
  • Direct pharmaceutical laboratory experience in a GMP-regulated environment.
  • Understanding of Good Manufacturing Practices (GMP), International Council for Harmonization (ICH) guidelines, and U.S. Food and Drug Administration (FDA) requirements.
  • Strong organizational skills and attention to detail.
  • Ability to prioritize tasks and meet deadlines.
  • Strong written and verbal communication skills.
  • Demonstrated proficiency in Microsoft Office applications.
  • Proficiency in English.

Standards and Expectations

  • Follow all Environmental Health & Safety policies and procedures.
  • Work collaboratively with team members, modeling positive team behaviors and partnering to meet project and departmental objectives.
  • Perform all duties in strict compliance with Thermofisher quality systems SOPs and GMP requirements.
  • Maintain a clean and orderly workspace.
  • Actively engage in departmental systems to support efficient workflow (e.g., visual management, scheduling systems, Smartsheet system).
  • Maintain a strong client and patient focus at all times.
  • Understand Key Performance Indicators (KPIs) and contribute to team performance improvement by identifying system enhancement opportunities and participating in problem-solving initiatives.
  • Demonstrate adaptability and openness to change, supporting shifts in priorities and new ways of working.
  • Proactively identify opportunities to improve procedural execution.
  • Communicate risks to timelines proactively.
  • Continuously develop skills and knowledge within the field.

Physical Requirements

Position requires standard ambulatory skills and physical coordination to move within laboratory and office environments. Ability to:

  • Stand, walk, stoop, kneel, and crouch for extended periods.
  • Lift, carry, and move light to medium weights (10–35 pounds).
  • Use arm, hand, and finger dexterity for grasping and typing for extended periods.
  • Maintain visual acuity to operate equipment, use a computer, and read materials for extended periods.
  • Sit, reach, talk, and hear for prolonged periods.

Use of Personal Protective Equipment (PPE) may be required, including safety glasses, safety shoes, lab coat, gloves, safety apron, and occasionally an organic respirator.

Disclaimer

This job description outlines the general nature and level of work performed in this role. It is not intended to be a comprehensive list of all responsibilities, duties, or qualifications. Managers and supervisors may assign additional duties as needed.

Nothing contained herein shall be construed to create an employment contract. Requirements may be expressed in brief terms. All language is intended to comply with applicable legislation in each country of operation, including alignment with the EU Equality Directive regarding recruitment and employment practices.

Compensation

The salary range estimated for this position based in Ontario is $41,900.00–$62,900.00.

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About Thermo Fisher

Thermo Fisher

Thermo Fisher Scientific Inc. is an American life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services.

10,001+

Employees

Waltham

Headquarters

Reviews

3.9

2 reviews

Work Life Balance

3.5

Compensation

2.5

Culture

3.5

Career

4.0

Management

3.0

65%

Recommend to a Friend

Pros

Large company with extensive resources

Structured internship program

Career opportunities in product management

Cons

Low compensation ($22/hour)

High cost of living in location

Expensive housing/rent

Salary Ranges

2,260 data points

Junior/L3

Mid/L4

Senior/L5

Junior/L3 · Manufacturing Technician

177 reports

$52,776

total / year

Base

$50,360

Stock

-

Bonus

$2,416

$42,159

$66,646

Interview Experience

8 interviews

Difficulty

3.0

/ 5

Duration

14-28 weeks

Offer Rate

12%

Experience

Positive 12%

Neutral 63%

Negative 25%

Interview Process

1

Application Review

2

Recruiter Screen

3

Hiring Manager Interview

4

Panel Interview

5

Final Interview

6

Offer

Common Questions

Technical Knowledge

Behavioral/STAR

Past Experience

Culture Fit

Industry Specific