GCMSMS ANALYST II - Eurofins BioPharma Product Testing Toronto, Inc.

Eurofins•Toronto, ON

99d•CA$55,000 - CA$70,000•Onsite

About The Position

Reporting directly to the Director- Chemistry, the Analyst I 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 I 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. Paticipates in general lab duties, including clean up, administration, logbook review and operations support

Requirements

Proficient in operating GCMS or GCMSMS and GC instruments with headspace FID and TCD detectors.
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.
Calibrate instruments.
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.
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.
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.
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.
2-7 years working with analytical instrumentation.
Ability to work directly from the USP or EP pharmacopeia and execute methods.
A solid background and understanding of Chemistry is mandatory.
Computer proficiency- Microsoft Office , especially Excel.

Nice To Haves

Experience working in contract Laboratory considered an asset.
Experience working with Pharmaceuticals.

Responsibilities

Provide basic technical support and analysis within the Biopharmaceutical Chemistry Testing Laboratory.
Perform method development, method validation, method transfer and routine analyses using GC-MS/MS and GC-FID instrumentation.
Analyze API, Raw Materials and Finished products for Assay, Impurities/ Residual solvents/ Pesticide analysis using GC instrument with minimum or no supervision.
Recognize OOS or out of trend results and assist laboratory manager in the completion of lab investigations.
Process and report analytical results.
Update and report work into LIMS.
Review technical data, documents, and proposals as required.
Troubleshoot technical issues/ difficulties with methods.
Coordinate 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.
Track instrument quality control.
Explain latest, applicable methods and techniques to perform various experiments and teach necessary techniques that need to be adopted to complete a particular experiment or an allotted assignment.
Design, preparation, and production of study materials including procedure manuals.
Perform other duties as assigned by Laboratory manager.
Sample preparation and Mobile phases preparation.
Ensure accurate reporting in lab books.
Conduct analysis and research and troubleshoot instrumentation/methods using a wide range of sophisticated equipment and instruments.
Perform other departmental tasks such as cleaning, supply ordering, assist with instrumentation training and maintenance.
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.
Mentor/train junior staff members and impart training to new recruits for operation, calibration and preventive maintenance of GC/GCMS/ HPLC/ LC-MS/MS, etc.
Write SOPs.
Ensure that work is performed in compliance with good manufacturing practices (GMP), standard operating procedures (SOPs) and the current test method.
Participate in general lab duties, including clean up, administration, logbook review and operations support.