Essential Functions
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.
Qualifications
Bachelor's Degree in healthcare related fields.
At least 2 years of relevant experience in a regulated laboratory environment.
Requires basic knowledge of assigned technical area, systems and procedures obtained through prior work experience (Biochemistry - Siemens ADVIA CENTAUR, Roche COBAS).
Demonstrates understanding of functional area and responsibilities (gating / troubleshooting.
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.
Q Solutions, IQVIA's laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers
