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. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization's clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
The 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 Q2 Solutions' standards.
With close direction from the Director, BioServices, BioServices Project Manager, the BioServices Project Leader 1 will:
- 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 Q2 Solutions SOP.
- Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Understanding of liquid chromatography and combination with mass spectrometry or In vitro and Immunoassay
- 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.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's Degree in a scientific field with 1 year of related experience; or equivalent combination of education, training and experience in GLP laboratory environment.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech .
- Regular sitting for extended periods of time.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
Job ID: R1069124