A 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 Duties:

Scientific/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

Project Management

• 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.

The 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 thr ugh 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.

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

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