Essential Functions
- Responsible for performing and documenting analytical procedures in accordance with company procedures and regulatory guidelines.
- Assists in troubleshooting and process improvements to increase data quality, lower costs, or reduce turnaround times to include, updating standard procedures, assisting with troubleshooting.
- Acts as a technical resource for laboratory staff and support the team in the absence of the line manager.
- 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.
- Contributes to CAPA investigations, deviations, and resolution.
- Responsible for clear, accurate, and timely communications with cross functional stakeholders.
- Assists in maintaining laboratory equipment and may offer suggestions for new equipment.
- Assists in good housekeeping of the lab environment, consistent with 6S standards.
- Assists in maintaining adequate inventory.
- Responsible for preparation of buffers and solutions for analysis, as required.
- Performs and documents 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.
- Participates in continuing education through self-study, attending training sessions and lectures and meetings.
- May lead a laboratory or cross functional projects and assist with implementation of changes.
- May be responsible for contributing to the design and development execution of routine methods/assays under moderate supervision.
- 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 2-3 years of experience in a regulated laboratory environment.
- Sound knowledge of principles, theories, and concepts in job area.
- Working knowledge of any applicable regulatory standards within area of responsibility.
- Proficiency with relevant laboratory techniques (Flow Cytometry).
- Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.
- Strong technical knowledge of complex testing procedures and science supporting the analysis.
- Proficiency with complex laboratory calculations regarding batches and specimens.
- Ability to troubleshoot laboratory equipment and resolve process issues.
- Good computer skills including proficiency with Microsoft Excel, PowerPoint and Word.
- Effective organizational and interpersonal skills.
- Effective communication and presentation skills.
- Capable of handling multiple tasks simultaneously.
- Strong attention to detail and accuracy.
- 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
