Descripción del trabajo
- 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 execution of routine bioanalytical methods/assays under moderate supervision.
- May contribute to technical discussions, experimental design, data review, sponsor inquiries related to LC/MS/MS analysis.
- 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 bioanalytical procedures and execution of LC/MS/MS methods.
- May support the team in the absence of the line manager.
- Exercise good judgment in assessing whether an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances through routine analysis.
- Identify abnormal progress of test procedure, potential quality failures, or otherwise unusual results and escalate to senior lab personnel immediately.
- Prepare data outputs for analysis by wet lab scientists.
- 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.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
- Bachelor's Degree in Biology, Chemistry, or similar field OR
- Master’s degree or equivalent combination of education, training, and experience.
- 3-5 years of related experience in method development or specific methodology area.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
- Basic knowledge of method development and analytical techniques for small molecule drug development 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.
- 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.
- 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.
- Ability to maintain a degree of independence to complete assigned tasks and projects.
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. 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
As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status
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