What are the responsibilities and job description for the Immunoassay Associate Scientist position at 5TA US Quintiles Laboratories?
Job Overview Responsible for performing routine analysis and laboratory testing procedures to obtain data for use in drug development and clinical trials research. RESPONSIBILITIES • Responsible for performing and documenting analytical procedures in accordance with SOPs and regulatory guidelines. • Performs routine data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances. • Identifies and documents potential performance errors or otherwise unusual results and escalates to senior lab personnel. • Prepares data analysis results for upload to LIMS system under the guidance of senior level staff. • Assists in quality investigations, deviations, and resolution. • Prepares buffers and solutions for analysis, as required. • Assists in the review and update of laboratory procedures and techniques. • Guides entry level staff on routine procedures and supports on-boarding of new staff. • Performs and document calibration and maintenance of laboratory equipment as assigned. • Performs and documents hands on training for other lab personnel in areas of proven competency as assigned. • Assists in the review and development of laboratory procedures and techniques. • Assists in the implementation of procedural changes as assigned. • Notifies inventory staff of supply shortages. • May represent lab team on cross functional projects. • Responsible for clear, accurate, and timely communications with cross functional stakeholders. • Participates in continuing education through self-study, attending training sessions and lectures and meetings. • Supports safety, quality, and 6S requirements and initiatives. • Complies with company's procedures and applicable regulatory requirements. MINIMUM REQUIRED EDUCATION AND EXPERIENCE • Bachelor's Degree required • Other equivalent combination of education and experience required OR • Bachelor's Degree Some CAP/CLIA lab locations may require a BS in chemistry, biology, or medical laboratory technology degree required REQUIRED KNOWLEDGE,SKILLS,AND ABILITIES • 6 months of experience in a regulated laboratory environment. • Requires basic knowledge of assigned technical area, systems and procedures obtained through prior work experience. • Demonstrates understanding of functional area and responsibilities. • Working knowledge of any applicable regulatory standards within area of responsibility, such as Good Laboratory Practices (GLP). • Proficiency with relevant laboratory techniques. • Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling. • Experience working with automation or specialized laboratory equipment. • Proficiency with routine and some non-routine laboratory calculations regarding batches and specimens including averages, means, standard deviations, and various quality control metrics. • Good computer skills using Microsoft Outlook, Word and Excel. • Capable of handling multiple tasks simultaneously. • Strong attention to detail and accuracy. • Ability to effectively collaborate with internal stakeholders. • Applicable certificaand/or other regulatory bodies by country, state, and/or other regulatory bodies Req Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes. To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
