Job DescriptionA Chemist II provides scientific knowledge and support to the company. They have extensive scientific knowledge and have been trained in analytical techniques, preferably LCMS. They have overall responsibility for the technical conduct of all assigned tests as well as for the interpretation, analysis, documentation, and reporting of results. They are the single point of study control. They assist in writing and helping to validate new protocols, analytical instrumentation, and perform method development. They serve as a master trainer in the company and they consult with clients on technical issues.
Essential DutiesScientific/General
Ensure procedures and reports are current with published methods
Ensure final reports accurately reflect the data, results and conclusions of the testing
Evaluates test results for suitability and designates acceptability
Prepare and review written procedures including SOPs, STPs, and other protocol test procedures and instructions that will be followed during analysis
Ensure method validation and test controls are adequate to support the test methodology
Ensure sample and data traceability are maintained throughout testing
Ensure calculations and statistics accurately reflect the raw data
Ensure test controls and monitors are accurately recorded and reviewed
Performs routine Maintenance and operates assigned analytical instruments
Troubleshoots analytical instrumentation problems, and decides the best course of action to remedy those problems
Continually work to optimize the results of the instruments with new parameters or instrument setups
Has performed data analysis and data interpretation, preferably LCMS.
Quality responsibilities
Reviews general data quality to determine where changes to methods or procedures could improve quality and throughput
Customer Focus
Uphold the NL service standard
Host client visits/audits
Consults with clients
Communicate regularly with sponsors and work to meet or exceed their expectations
Assists with questions from sales, service center, quality and regulatory teams
Communicates and consults with sponsors to set up proper test plans and other testing parameters
Meets or exceeds sponsors expectations
Assist with failure investigations for the laboratory
Work with SL/DM in managing test work flow to ensure sponsor expectations are met.
Meet turn around deadlines.
Work with other sections/functions to manage workflow, validations, and other projects that will improve efficiencies and the sponsor’s experience.
Coordinate communication between clients and laboratory staff
Regulatory Compliance
Reviews general data quality to determine where changes to methods or procedures could improve quality and throughput
Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.)
Know and follow ISO 17025 and ISO 9001 guidelines
Know and follow company policies and procedures.
About UsThe name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.
Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.
OrganizationNelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,800 customers across 14 facilities in the United States, Mexico, Asia and Europe. We have a comprehensive array of over 800 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues. Learn more about Nelson Labs at www.nelsonlabs.com
Safeguarding Global Health® - with every test we complete.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Biotechnology Research
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