Scientist, Lab Operations

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.

Job Overview

Responsible for performing a variety of technical procedures and experimental execution in support of sample analysis and validation.  Responsible for root cause analysis, troubleshooting, and supporting process improvements.

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

• Associate's Degree  Req Or

• Bachelor's Degree in biology or chemistry Req

• 1 year 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.

• 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.