Documentation Reviewer II

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionDocumentation Reviewer II (internal position only)SummaryResponsible for independently reviewing laboratory technical documents and associated raw data to ensure accuracy, integrity, and compliance with Good Manufacturing Practices (GMP) and established procedures. Ensures adherence to approved methods, protocols, and SOPs, and collaborates with laboratory scientists to resolve discrepancies and implement required corrections. Support the timely delivery of high-quality results and contributes to continuous improvement initiatives to enhance quality, and operational efficiency.Essential Functions:   Independently review routine technical documents (e.g., metrology equipment PQ,PM, calibrations, new equipment protocols,  batch testing, stability studies, and method validation data) and associated raw data to ensure accuracy, completeness, compliance,  and timely delivery.Verify that approved test methods, protocols and Standard Operating Procedures (SOPs) have been properly followed by the scientists.  Ensure the integrity, consistency, and traceability of all generated and reported data in compliance with GMP requirements.Collaborate with Laboratory scientists to resolve discrepancies and ensure all required corrections are completed accurately and in accordance with GMP requirements.Escalate omissions, incomplete documentation, data inconsistencies, or other irregularities to the department supervisor or manager as appropriate.Support the timely release and reporting of laboratory data through effective and thorough document review. Participate in continuous improvement initiatives to enhance documentation quality, compliance, and operational efficiency.Perform alternating or rotating shift work, as required by business needs.Maintain a safe working environment and promptly report potential hazards, unsafe conditions, or safety concerns REQUIRED QUALIFICATIONS Education:Bachelor of Science in Chemistry or related scientific discipline. Experience:Minimum of 2 years demonstrated proficiency as a documentation reviewer I.Familiar with current ALOCA principles. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.  Knowledge, Skills and Abilities: Familiar with the lab analytical technologies (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV) spectroscopy, titration, and raw material IR 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, highly detail-oriented, and capable of managing multiple priorities and meeting deadlines. Strong problem-solving abilities with a logical, methodical approach to reviewing and interpreting scientific data. Effective interpersonal, verbal, and written communication skills.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 a clean and orderly workspace at all times.  Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Maintain a strong client- and patient-focused mindset 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 activities. Demonstrate adaptability, a positive mindset, and openness to change. Proactively identify areas for improvement in the execution of procedures. Communicate potential risks to timelines in a proactive manner.  Consistently strives to improve skills and knowledge in relevant 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. 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 requirements.  Managers and supervisors may assign other duties as needed. Nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any 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. CompensationThe estimated annualized pay range for this position in Ontario is $50,800.00–$76,150.00.