QC Particulate Scientist II

Nature and Scope The QC Particulate Scientist II will demonstrate proficiency in advanced techniques and expertise with particle isolation, manipulation and particle forensics supporting product investigations, process evaluation, examination of customer complaint CRU, source particle characterization and mitigation programs, and R&D container closure studies and will play a supporting role in method development, creation and certification of test sets, and routine analyses for product release by USP <788> & <790>. Essential Duties and Responsibilities Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time. Tracking/documentation of incoming samples. Prepare laboratory reagents for particulate analysis Operate analytical instruments (ie: SEM/EDS, FTIR, Flow Microscopy) Perform USP <788> & <790> analyses. Perform forensic analysis on unknown particulate samples. Perform verification of sulfur treatment on incoming glass Document all data generated from analyses following GDP. Assist with data entry for analysis and trending. Support the creation and certification of test sets Order and track laboratory supplies. Clean and disinfect laboratory spaces/work areas. Assist in the characterization of particulate matter. Perform routine analysis of final dosage forms and stability samples. Assist in the IQ/OQ/PQ of new laboratory equipment (e.g., new particulate matter systems) Assist in the performance of investigations. Maintain laboratory equipment (e.g., particulate systems, SEM/EDS, FTIR, Flow Microscopy). Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelors degree in a scientific discipline required. Minimum of 3 years in a Quality laboratory environment required. Aseptic processing experience preferred. Physical Environment and Requirements Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision. Expected Salary Range: $79,900-86,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidates qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf Alert: Were aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com. Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.