Descripción del trabajo
Responsible for performing routine analysis and laboratory testing procedures to obtain data for use in drug development and clinical trials research.
- Responsible for performing and documenting analytical procedures in accordance with SOPs and regulatory guidelines.
- 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.
- Assists in quality investigations, deviations, and resolution.
- Prepares buffers and solutions for analysis, as required.
- Assists in the review and update of laboratory procedures and techniques.
- Guides entry level staff on routine procedures and supports on-boarding of new staff.
- Performs and document 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.
- Assists in the review and development of laboratory procedures and techniques.
- Assists in the implementation of procedural changes as assigned.
- Notifies inventory staff of supply shortages.
- May represent lab team on cross functional projects.
- Responsible for clear, accurate, and timely communications with cross functional stakeholders.
- Participates in continuing education through self-study, attending training sessions and lectures and meetings.
- Supports safety, quality, and 6S requirements and initiatives.
- Complies with company's procedures and applicable regulatory requirements.
MINIMUM EDUCATION REQUIRED AND EXPERIENCE
- Bachelor's Degree Required Or
- Other equivalent combination of education and experience Required Or
- Bachelor's Degree Some CAP/CLIA lab locations may require a BS in chemistry, biology, or medical laboratory technology degree Required
- 6 months of experience in a regulated laboratory environment.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- Requires basic knowledge of assigned technical area, systems and procedures obtained through prior work experience.
- Demonstrates understanding of functional area and responsibilities.
- Working knowledge of any applicable regulatory standards within area of responsibility, such as Good Laboratory Practices (GLP).
- Proficiency with relevant laboratory techniques.
- Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.
- Experience working with automation or specialized laboratory equipment.
- Proficiency with routine and some non-routine laboratory calculations regarding batches and specimens including averages, means, standard deviations, and various quality control metrics.
- Good computer skills using Microsoft Outlook, Word, and Excel.
- Capable of handling multiple tasks simultaneously.
- Strong attention to detail and accuracy.
- Ability to effectively collaborate with internal stakeholders.
- Applicable certificate and/or other regulatory bodies by country, state, and/or other regulatory bodies Required
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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