Documentation Reviewer II

1 month ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time

Work Schedule

10 hr shift/days

Environmental Conditions

Office

Job Description

Summary:

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

Operations.

Essential Functions:

 Review independently 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 scientist/chemists/technicians 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.

 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)

REQUIRED QUALIFICATIONS

Education:

Bachelor of Science in Chemistry or related science.

Experience:

Minimum 3 years of previous pharmaceutical analytical development experience.

Previous document reviewer experience preferred.

Familiar with current ALOCA principles.

Must have Empower software experience

Must be able to work afternoons

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) spectroscoy, titration, and raw material testing. Excellent

written and oral communication skills. Good working knowledge of Good Manufacturing Practices,

International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA)

requirements. Strong organizational skills and detail oriented. Should have GMP chromatography

experience (Specifically EMPOWER is an asset). Direct pharmaceutical experience in a GMP environment.

Ability to meet deadlines and prioritize. Demonstrated computer proficiency with Microsoft Office programs.

Proficiency 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 systems SOP's 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:

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.

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