Senior Scientist LCMS

Job OverviewAct as a technical specialist for laboratory operations including identifying and driving continuous process improvement initiatives and oversee the technology transfer process. Performs work in accordance with ICH E6 Guideline for Good Clinical Practice.

Responsibilities • Perform and document all specimen test procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines.• Complete and prepare documentation in compliance with regulatory and corporate guidelines.• Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that results are within acceptable tolerances.• Perform and document hands on training for other Laboratory Associates in areas of proven competency as assigned.• Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to Team Lead or Laboratory Management immediately.• Act as a back up in any area of daily laboratory operations, as needed,  and meet expectations of the  laboratory associate job responsibilities in that area.• Oversee the technology transfer of methods and SOPs from other groups within IQVIA such as Research and Development departments. This includes working with those departments to fill gaps that are identified to ensure the technology will be sustainable and scalable in laboratory operations.• Demonstrate advanced domain knowledge to provide input on technical inquiries and provide leadership in troubleshooting projects. Including application of root cause analysis and advanced problem solving techniques.• Produce technical documentation for laboratory assays and associated pipelines across all service areas in the business (i.e. Laboratory Ops, Quality Systems, Information Technology, and Finance).• Identify and lead continuous process improvement initiatives for laboratory operations, including but not limited to the following responsibilities:    ◦     Review of laboratory metrics to identify initiatives as well as establish additional metrics such as cost savings that are associated with process improvement initiatives.    ◦     Work with stakeholders on process improvement initiatives to present projects and ensure that goals are met.    ◦     Independently identify and evaluate vendor platforms to that may help meet goals of the initiatives.    ◦     Documentation of all project aspects including formal validations of laboratory methods.    ◦     Present findings to a wide variety of audiences internal and external to IQVIA.

Minimum Education and Experience

• Bachelor's Degree  Required• 4 years’ experience manipulating RNA and/or DNA in a clinical, research, academic or commercial/production environment Required Or• Equivalent combination of specialized experience and training in biology or chemistry laboratory environment required

Required Knowledge Skills and Abilities• Working knowledge of Good Laboratory Practices, Clinical Laboratory Improvement Amendments (CLIA) and any other governing regulatory requirements.• Expertise with pipetting and other general molecular biology laboratory techniques.• Proficiency with laboratory calculations regarding batches and specimens including but not limited to averages, means, standard deviations, and various quality control metrics.• Excellent oral and written communication skills.• Strong organizational skills, and close attention to detail are essential.• Capable of handling multiple tasks simultaneously and independently.• Demonstrated “everyday leadership” skills.

Q² Solutions,IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. q2-solutions-eoe

Q² Solutions’ ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding COVID-19 vaccination status.q2-solutions-covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $75,400.00 - $113,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.