Documentation Reviewer I

6 months ago

Mississauga, Canada Thermo Fisher Scientific Full time

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

**How will you make an impact?**

Responsible for independently reviewing various technical reports and raw data generated in Lab Operations.

**What will you do**:

- Review 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 agreed schedule.
- 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 scientists/chemists/technicians to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices’ standard.
- Notify 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)
- Maintain a safe working environment and report potential hazards.
- Perform alternating or rotating shift work (as required)

**How will you get here**:
**Education**:
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.

**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, 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.

**Physical Requirements**:
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. Use of Personal Protective equipment may be required and may include any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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