Scientist II or III - Stability Sample Management - FSP

Job description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Scientist 2 or 3 - Stability Sample Management position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This role does not offer sponsorship. Qualifications - B.S./M.S. in Chemistry or related discipline and relevant years of experience as listed below Scientist 2 - B.S. with 1-2 years of experience; M.S. with 0-1 years Scientist 3 - B.S. with 3-5 years of experience; M.S. with 1-2 years Overview: T he Scientist is responsible for supporting stability sample management activities in a GMP-regulated environment, including stability study support, sample handling, documentation, and regulatory compliance for late-stage pharmaceutical development programs. Responsibilities: Candidates must routinely lift, carry, and place filled sample bins, shipping containers, and cold-chain coolers (e.g., bins loaded with sample bottles) Coordinate set up of new stability studies Perform routine sample pulls from stability chambers according to established procedures Prepare and label samples for stability studies Prepare samples for shipments to multiple testing laboratories, and process samples for destruction Perform second scientist review of analytical data and GMP documents Notify management of non-conforming events related to the tasks Ensure completion of applicable GMP training prior to performing tasks Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures Maintain accurate records (e.g., sample chain of custody) Maintain up-to-date training in cGMPs Maintain up-to-date knowledge of USP, Ph.Eur, and ICH Guidances Required Skills and Experience Hands-on experience in a pharmaceutical cGMP environment supporting stability sample management and stability chamber operations Experience in a fast-paced, dynamic GMP-regulated environment Experience with LIMS and electronic laboratory notebook Strong customer service orientation with the ability to effectively support multiple cross-functional stakeholders Ability to troubleshoot application issues and identify timely resolutions Strong written and verbal communication skills Excellent attention to detail Proficiency with MS Office applications, including Word, Excel, and PowerPoint Self-motivated with demonstrated efficiency, adaptability, and a positive attitude About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.