GC/GCMSMS Analyst II - Eurofins BioPharma Product Testing Toronto, Inc.

Job description

Reporting directly to the Director - Chemistry, the Analyst II will be responsible for providing basic technical support and analysis within the Biopharmaceutical Chemistry Testing Laboratory. This is a deadline-based, high-pressure work environment with on-going projects for a variety of clients. The Analyst II will have over 2 to 7 years of laboratory testing experience with demonstrated ability to complete role/duties that are more complex. Has handled variety of instrumentations for analytical testing and will be able to work independently with minimal/no supervision. The incumbent must be energetic, exceedingly well-organized, flexible, and must have the ability to interact with customers and staff in a fast-paced environment, sometimes under pressure, while remaining proactive, resourceful, and efficient. A high level of professionalism and confidentiality is crucial to this role. The Analyst II must: Proficient in operating GCMS or GCMSMS and GC instruments with headspace FID and TCD detectors. Perform method development, method validation, method transfer and routine analyses using GC-MS/MS and GC-FID instrumentation. Learn and apply knowledge with additional advanced instrumentation techniques (HPLC, LC-MS/MS, ICP-MS, etc.) and software (Waters, Chromeleon, Analyst, Mass Hunter) as necessary Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs). Perform instrument calibration, qualification and preventative maintenance program as necessary. Analyze API, Raw Materials and Finished products for Assay, Impurities/ Residual solvents/ Pesticide analysis using GC instrument with minimum or no supervision. Recognizes OOS or out of trend results and assists laboratory manager in the completion of lab investigations. Calibrate instruments. Process and report analytical results. Update and report work into LIMS. Review technical data, documents, and proposals as required. Proficient in Microsoft office programs (Outlook, Word, and Excel). Hands on experience with pharmaceutical data acquisition software e.g. Chromeleon, Mass hunter, e-LIMS, eQMS etc. Troubleshoot technical issues/ difficulties with methods. Co-ordinate with team members to perform method transfers between R&D group to QC group. Promote and maintain a safe and healthy working laboratory environment in compliance with established health and safety procedures. Strong interpretation of routine analysis or tests. In-depth understanding of chromatography principles, types and techniques. Have high troubleshooting skills, both with instruments and methods. Apply technical judgment to determine potential problems for samples. Track instrument quality control. Appropriately follow safety, operational integrity and quality control requirements for the work that is done. Be able to work under GMP guidelines, and be proficient with USP and pharmaceutical testing. Explaining latest, applicable methods and techniques to perform various experiments and teaching necessary techniques that need to be adopted to complete a particular experiment or an allotted assignment. Competent research and study skills to learn about innovative methodologies and equipment used for problem solving and troubleshooting. Accountable for the integrity and traceability of all data generated and reported Design, preparation, and production of study materials including procedure manuals. Perform other duties as assigned by Laboratory manager. Key Responsibilities: Sample preparation and Mobile phases preparation. Documentation: Ensuring accurate reporting in lab books. Using a wide range of sophisticated equipment and instruments to conduct analysis and research and trouble shoot instrumentation/methods Perform other departmental tasks such as cleaning, supply ordering, assist with instrumentation training and maintenance, etc Perform analytical tests utilizing GC, HPLC/UPLC, UV, IR, FTIR, KF and other laboratory instruments. Assess, compare and perform risk assessments for compendial method compliance according to USP, EP, and other regulations Mentoring/training junior staff members and Imparting training to new recruits for operation, calibration and preventive maintenance of GC/GCMS/ HPLC/ LC-MS/MS, etc . Writing SOPs Ensure that work is performed in compliance with good manufacturing practices (GMP), standard operating procedures (SOPs) and the current test method. Participates in general lab duties, including clean up, administration, logbook review and operations support Education: A B.Sc. degree preferably in Chemistry, or diploma in related filed. A solid background and understanding of Chemistry is mandatory Computer proficiency - Microsoft Office, especially Excel Experience: 2-7 years working with analytical instrumentation. Ability to work directly from the USP or EP pharmacopeia and execute methods Experience working in contract Laboratory considered an asset. Experience working with Pharmaceuticals. WORKING CONDITIONS: This position will be working in a laboratory environment where standing is required for greater than 50% of the time. Light lifting requirements of no more than 30 lbs. Hazardous materials are handled using established safety procedures and appropriate PPE. Shift work and overtime may be required, as well as working periodic weekends and/or evenings.