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Job Description
Position Summary:
The Chemistry Analyst III (Laboratory Lead) applies scientific principles, methods and techniques to troubleshoot chemical and instrumental analyzes, optimize current methods and processes, perform test methods and equipment validations, and identify/lead laboratory projects. The Lab Lead will work directly with the area supervisor to ensure timely release of product and facilitate the training of all laboratory analysts.
Essential Duties & Responsibilities:
Coordination of day-to-day activities of laboratory analysts which include scheduling, sample prioritization, batch record review and release and other activities as required under the direction of the area supervisor. Perform complex chemical and instrumental analyses to support laboratory functions such as in-process solutions, raw materials (API / Excipients), commodities, blended resin, film and final product solutions in multiple laboratories on an as needed basis. Train new analysts in daily operations, documentation, instrumental & wet chemical methods (both theory and practice). Support the area supervisor in the investigation of inconsistent results and possible root causes and solutions, including documentation of the investigation via applicable laboratory investigation / exception report documentation and the associated system. Perform preventive maintenance (PM). Troubleshoot and resolve all instrument problems in the laboratory. Work with vendors to evaluate instruments, and make decisions involving future instrument purchases based on needs and costs. Assist with method development, method validation / transfer studies, and method remediation activities. Set daily and weekly short-term goals to ensure timely release of product in conjunction with the area supervisor. Adhere to cGMP's, SOP's and plant policies/guidelines. May be cross-trained to work in other laboratory areas as dictated by the needs of the department. Perform other related duties as assigned or required.
Knowledge, Skills & Qualifications:
Must have successfully completed projects, demonstrating good communication, word processing and writing skills, and organizational and time management skills. Must be able to provide general guidance to other analysts on a day-to-day basis. Must follow organized thought processes and have the visual acuity to accurately complete the extensive necessary documentation, plus a thorough understanding of the chemistry and theory involved. Must have technical writing capability and be familiar with validations and qualifications. Capable of operating complex instrumentation with limited supervision. Must be able to apply standard scientific principles, methods and techniques to trouble-shoot and resolve common analytical problems and technical service requests. Must be able to resolve routine analytical and quality problems with minimal assistance. Position requires an understanding and capability of performing maintenance on laboratory instrumentation on a daily and monthly basis. Must be able to manipulate algebraic equations on a daily basis. Must be able to use mathematics to solve routine problems. Must be able to trouble-shoot and resolve a myriad of routine instrumental problems. Must demonstrate good organizational and time management skills. Must possess good communication and writing skills and be able to work effectively with all levels of individuals within the organization. Must be able to perform tests quickly and efficiently without sacrificing accuracy, safety or quality.
Education and Experience:
Bachelor's Degree is required: Chemistry, Chemical Engineering, or Chemical Science (other science degrees will be considered) At least 3-4 years recent analytical instrumentation experience is required; or a BS degree in Biology with 4+ year's recent analytical instrumentation experience. Thorough knowledge of the various instruments used in the lab, including: theory, preventive maintenance, troubleshooting and compendia terminology and requirements.
Minimum Qualifications:
Must be at least 18 years of age.
Travel Requirements:
Typically requires travel less than 5% of the time.
Physical Requirements and Work Environment:
Types of problems encountered: Individual will generate data that will be used as the criteria in the decision to continue or stop manufacture of solutions and filling process. Must be able to work flexible schedules, including overtime, in response to work demand. Office and laboratory environment. Frequent exposure to hazardous chemicals, the numerous methodologies that are required to test product, and the time constraints under which the work is accomplished. Must be able to lift 20 lbs unassisted. Innovation, Impact, and Purpose. Find Your Future Here. We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption. When you work here, you become part of something bigger—a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide. We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters. Join us and help shape the future of IV solutions.
EEO Statement:
Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at austinhr@icumed.com. We are committed to providing equal access and opportunities for all candidates.
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