Scientist II or III - Bioanalytical Sample Management - FSP

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 Bioanalytical 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 position does not offer any sponsorship. Responsibilities Maintain and manage inventory of GLP and Clinical bioanalytical samples and critical reagents Utilize one or more Laboratory Information Management Systems (LIMS) to track sample chain of custody from receipt through disposal/shipping Coordinate domestic and international sample or reagent shipments off-site. Participate in CTU maintenance and alarm handling Retrieve and provide materials to bioanalytical staff on site Communicate with clinical sites, central lab, or on-site collection areas for receipt of materials and discrepancy resolution. Qualifications Scientist 2: Bachelors degree with 1-2 yrs of experience in a biological science discipline Scientist 3: Bachelors degree with 3-5 yrs of experience or Master’s degree with 1 yrs of experience in a biological science discipline Required Skills and Experience Strong knowledge in GxP and compliance guidelines, preferably in a bioanalytical laboratory environment Experience managing sample chain of custody within a GLP/GMP lab Utilize electronic laboratory notebooks for laboratory documentation Operate within the confines of departmental SOPs and regulatory guidance’s Capable of working independently under moderate supervision Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators Good people skills to effectively manage and interact with partners/customers in a high-pressure environment Ability to work efficiently and to adapt to changes in assignments consistent with new or changing project priorities Desired Skills and Experience Computer literacy knowledge (e.g. MS Office) and experience using a laboratory LIMS system (e.g. Watson LIMS, Labware LIMS, Benchling, etc) May Author SOPs associated with sample or reagent management processes. 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. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40 years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™