JOB OVERVIEW

Responsible for LCMS operation, method development, sample analysis, critical review of data, data interpretation, reporting of results including report preparation and critical review.

Responsible for performing a variety of technical procedures and experimental execution in support of sample analysis, method development, and qualification in a bioanalytical laboratory. 

RESPONSIBILITIES

• Responsible for performing and documenting analytical procedures in accordance with company procedures and regulatory guidelines.
• Complete and prepare documentation in compliance with regulatory and corporate guidelines.
• May be responsible for contributing to the design and development execution of routine methods/assays under moderate supervision.
• May contribute to technical discussions, experimental design, data review, sponsor inquiries.
• Assist in troubleshooting and process improvements to increase data quality, lower costs, or reduce turnaround times.
•  May lead a laboratory or cross functional project and assist with implementation.
• Act as a technical resource for laboratory staff in area of expertise.
•  May support the team in the absence of the line manager.
• Exercise good judgment in assessing whether analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances through routine data analysis.;
• Identify abnormal progress of test procedure, potential quality failures, or otherwise unusual results and escalate to senior lab personnel immediately.
• Prepare data analysis results for upload to LIMS system under the guidance of senior level staff.
• Preparation of buffers and solutions for analysis, as required.
• Perform and document calibration and maintenance of laboratory equipment as assigned.
• Perform and document hands on training for other lab personnel in areas of proven competency as assigned.
• Participate in continuing education through self-study, attending training sessions and lectures and meetings.
• Production of quality data and documentation in adherence to timelines in accordance with regulatory requirements.
•  Support safety and 6S requirements and initiatives.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Basic knowledge of method development and analytical techniques for assigned technical area including principles, theories, concepts, and instrumentation, typically obtained through advanced education.
•  Understanding of sample handling and preparation.
•  General awareness of the drug development process and the interaction of method development in that process. 
• LC-MS/MS experience is required; preferably including method development experience.
• Working knowledge of regulatory agency standards within the area of responsibility. 
•  Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling
•  Strong technical knowledge of complex analytical techniques and science supporting the analysis.
•  Proficiency with data analysis techniques and calculations.
•  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 co-workers, managers, and clients.
•  Ability to maintain a degree of independence to complete assigned tasks and projects.

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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

Q² Solutions’ ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding COVID-19 vaccination status.https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $59,400.00 - $89,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.