Associate Quality Control Scientist

2 months ago

Livingston, West Lothian, United Kingdom IQVIA LLC Full time
About the Role

We are seeking a highly skilled Associate Quality Control 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
  1. Perform Analytical Procedures: Conduct and document analytical procedures in accordance with Standard Operating Procedures (SOPs) and regulatory guidelines.
  2. Data Analysis: Perform routine data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances.
  3. Error Identification and Escalation: Identify and document potential performance errors or otherwise unusual results and escalate to senior laboratory personnel.
  4. Data Preparation: Prepare data analysis results for upload to Laboratory Information Management System (LIMS) under the guidance of senior level staff.
  5. Quality Investigations: Assist in quality investigations, deviations, and resolution.
  6. Preparation of Buffers and Solutions: Prepare buffers and solutions for analysis, as required.
  7. Training and Development: Assist in the review and update of laboratory procedures and techniques, and perform hands-on training for other lab personnel in areas of proven competency.
  8. Equipment Calibration and Maintenance: Perform and document calibration and maintenance of laboratory equipment as assigned.
  9. Inventory Management: Notify inventory staff of supply shortages.
  10. Representative: May represent lab team on cross-functional projects.
  11. Continuing Education: Participate in continuing education through self-study, attending training sessions, lectures, and meetings.
  12. Compliance: Support safety, quality, and 6S requirements and initiatives, and comply with company's procedures and applicable regulatory requirements.
Requirements
  1. Education: Bachelor's Degree or equivalent combination of education and experience.
  2. Experience: 6 months of experience in a regulated laboratory environment.
  3. Technical Knowledge: Basic knowledge of assigned technical area, systems, and procedures obtained through prior work experience.
  4. Regulatory Knowledge: Working knowledge of any applicable regulatory standards within area of responsibility, such as Good Laboratory Practices (GLP).
  5. Laboratory Techniques: Proficiency with relevant laboratory techniques.
  6. Laboratory Safety: Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.
  7. Automation and Equipment: Experience working with automation or specialized laboratory equipment.
  8. Calculations: Proficiency with routine and some non-routine laboratory calculations regarding batches and specimens including averages, means, standard deviations, and various quality control metrics.
  9. Computer Skills: Good computer skills using Microsoft Outlook, Word, and Excel.
  10. Certifications: Applicable certifications or other regulatory bodies by country, state, and/or other regulatory bodies.

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