Document Reviewer II - QA- Afternoon Shift

**Work Schedule** Second Shift (Afternoons) **Environmental Conditions** Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse **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. This position is M-F 3:00pm-11:30m. **Essential Functions:** + Review all regular technical documents (e.g., batch testing, stability testing,methoddevelopment andvalidation, rawmaterialsand packaging components) and raw data generated in theLaboratorywith high quality and deliver within standardtime. + Release Raw Material and Packaging Components in SAP + ReleaseofProductCertificate ofAnalysisusing applicableLIMS software + Ensurethe test methods,protocolsand Standard Operating Procedures (SOPs) have been followed bythe scientists/chemists. + Verifythe integrity and traceability of all data generated and reported. + Follow up with scientist/chemists to ensure that all necessary corrections are correctedin accordance withGood Manufacturing Practices' standards. + Notifydepartment supervisor/manager regarding omissions, incomplete testingresultsor other irregularities. + Write/Update SOPs and initiate change control when necessary. + Adhere toassigned 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 3 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 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. 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 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 area. There 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. **Compensation** The salary range estimated for this position based in Ontario is $50,800.00-$76,150.00. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.