Responsible for contributing to the design of and development execution under moderate supervision.
Executes assigned tasks and activities to support assay/method development.
Contributes to technical discussions, experimental design, data review, and sponsor inquiries.
Assists in troubleshooting and process improvements to increase data quality, lower costs, or reduce turnaround times.
Presents assay development results in support of data review and transfer to Validation or Production lab.
Works collaboratively with cross functional stakeholders to facilitate the assay development process.
Assists in the preparation of technical reports, summaries, protocols, and quantitative analyses.
Maintains laboratory notebooks under applicable regulatory standards and good documentation practices.
Follows all appropriate lab and company SOP\'s.
Participates in continuing education through self-study, attending training sessions and lectures and meetings.
Responsible for the 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 relevant scientific discipline required
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Required knowledge, skills and abilities
Basic knowledge of assay/method development and/or assigned methodology principles, theories, concepts, and instrumentation, typically obtained through advanced education. Understanding of sample handling and preparation.
Proficiency with relevant laboratory techniques.
Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling. General awareness of the broader drug development process and the interaction of method development in that process.
Ability to troubleshoot laboratory equipment and resolve process issues. Basic understanding of requirements under relevant regulatory standards for assigned work area.
Good computer skills including proficiency with Microsoft Excel, PowerPoint and Word. Capable of handling multiple tasks simultaneously.
Strong attention to detail and accuracy. Effective organizational and interpersonal skills.
Effective communication and presentation skills.
Ability to work closely with other members of the laboratory.
Ability to maintain a minor degree of independence to complete assigned tasks and projects.
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.
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.
As the COVID-19 virus continues to evolve, Q\xc2\xb2 Solutions\' ability to operate and provide certain services to customers and partners necessitates Q\xc2\xb2 Solutions and its employees meet specific requirements regarding vaccination status.