Project Leader 1 , BioServices

Job OverviewThe BioServices Project Leader 1 will focus on the internal execution of day to day project work.  The BioServices Project Leader 1 will work closely with the BioServices Project Manager and BioServices Project Leader 2 to learn the procedures and practices necessary to ensure that all project work stays on schedule and is done according to IQVIA standards.

RESPONSIBILITIES • Plan day to day activities for assigned projects.

• Create work lists for laboratory staff.

• Request samples from Laboratory Operations for analysis.

• Provide daily direction and feedback to laboratory staff.

• Import and process run data in Watson.

• Accept or reject run results.

• Work with Project Manager to investigate failed runs and runs with analytical issues.

• Write up analytical results and assemble run binders.

• Submit accurate weekly assessment of resource requirements  for scheduling purposes.

• Attend weekly scheduling and revenue update meetings and provide updates on project progress.

• Maintain run trackers for assigned projects.

• Provide timely MS timesheets for study tracking.

• Review data (run binders, data tables, etc) for regulatory compliance and scientific quality.

• Track supply and expiration of project related materials (LC columns, reference compounds, stock solutions, etc).

• Assemble data tables for client submission.

• Design validation experiments to direct wet lab staff.

• Archive all studies in a timely manner in accordance with Quintiles SOP.

• Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE• Bachelor's Degree Scientific field required• 1 year of related experience. Equivalent combination of education, training and experience in GLP laboratory environment.

REQUIRED KNOWLEDGE,SKILLS,AND ABILITIES• Understanding of liquid chromatography and combination with mass spectrometry or In vitro and Immunoassay techniques.

• Understanding of sample extraction and routine laboratory procedures.. Understanding of method development and validation of assays.

• Ability to interact with internal clients, and work to objectives/timelines.

• Excellent attention to detail and communication skills.

• Ability to follow verbally communicated or draft procedures.

• Ability to describe clearly experimental objectives and data conclusions.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

• Understanding of liquid chromatography and combination with mass spectrometry or In vitro and Immunoassay techniques.

• Understanding of sample extraction and routine laboratory procedures.. Understanding of method development and validation of assays.

• Ability to interact with internal clients, and work to objectives/timelines.

• Excellent attention to detail and communication skills.

• Ability to follow verbally communicated or draft procedures.

• Ability to describe clearly experimental objectives and data conclusions.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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 $59,400.00 - $89,100.00. 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.