Document Reviewer II

Job description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

How will you make an impact? Responsible for reviewing all data, lab notebooks, E-Data and completed Certificates of Analysis (C of A) and Stability reports generated in the Laboratory. Verifies and confirms the integrity What will you do? Reviews all regular technical documents (e.g., batch testing, stability testing, method development and validation, raw materials and packaging components) and raw data generated in the Laboratory with high quality and deliver within standard time. Reviews and approves Trackwise OOS/DRs generated by laboratory Release Raw Material and Packaging Components in SAP Ensures the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists/chemists. Verifies the integrity and traceability of all data generated and reported. Follows up with scientist/chemists to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices’ standards. Notifies department supervisor/manager regarding omissions, incomplete testing results or other irregularities. Write/Update SOPs and initiate change control when necessary Adhere to assigned schedules and standard times Perform alternating or rotating shift work (as required). Education: Bachelor of Science in Chemistry or related science. Experience: Minimum 2 years of previous pharmaceutical analytical development experience. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills & Experience Basic understanding the common analytical technologies (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV) spectroscoy, 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. Core Competencies: Put the Customer First - Think and act with a customer-centric mindset to deliver exceptional customer experiences. Own Your Results - Take personal accountability for all you do and always exercise good judgement. Find a Better Way Everyday - Be intellectually curious and embrace Practical Process Improvement (PPI). Comply with all Environmental Health & Safety Policies and Procedures. Work harmoniously 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, shared laboratory assets). Understand Key Performance Indicators (KPI's) 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 identifies areas for improvement in the execution of analytical procedures. Communicate risks to timelines of deliverables in a proactive manner. Consistently strives to improve skills and knowledge in pharmaceutical development (an asset). Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com

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