Essential Functions
- 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.
Qualifications
- Bachelor's Degree in healthcare related fields
- At least 3 years of relevant experience in a regulated laboratory environment.
- Requires advance knowledge of assigned technical area, systems and procedures obtained through prior work experience (Flow Cytometry).
- Demonstrates understanding of functional area and responsibilities (gating, troubleshooting)
- Working knowledge of any applicable regulatory standards within area of responsibility, such as Good Laboratory Practices (GLP).
- 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.
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
