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Associate Quality Control Scientist
2 months ago
Job Summary:
We are seeking an Associate Qc Scientist to join our team at IQVIA LLC. As a key member of our laboratory team, you will be responsible for performing routine analysis and laboratory testing procedures to obtain data for use in drug development and clinical trials research.
Key Responsibilities:
- Perform and document analytical procedures in accordance with SOPs and regulatory guidelines.
- Conduct routine data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances.
- Identify and document potential performance errors or otherwise unusual results and escalate to senior lab personnel.
- Prepare data analysis results for upload to LIMS system under the guidance of senior level staff.
- Assist in quality investigations, deviations, and resolution.
- Prepare buffers and solutions for analysis, as required.
- Assist in the review and update of laboratory procedures and techniques.
- 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.
- Assist in the review and development of laboratory procedures and techniques.
- Assist in the implementation of procedural changes as assigned.
- Notify inventory staff of supply shortages.
- May represent lab team on cross-functional projects.
- Participate in continuing education through self-study, attending training sessions, lectures, and meetings.
- Support safety, quality, and 6S requirements and initiatives.
- Comply with company's procedures and applicable regulatory requirements.
Requirements:
- Bachelor's Degree or equivalent combination of education and experience.
- Some CAP/CLIA lab locations may require a BS in chemistry, biology, or medical laboratory technology degree.
- 6 months of experience in a regulated laboratory environment.
- Requires basic knowledge of assigned technical area, systems, and procedures obtained through prior work experience.
- 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.
- Applicable certificated or other regulatory bodies by country, state, and/or other regulatory bodies.