Job Description

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 biology or chemistry Req
• 1 year of experience in a regulated laboratory environment. Pref
• 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.

Q\xc2\xb2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

IQVIA