Assoc Scientist , LCMS

JOB OVERVIEW

Responsible for performing routine analysis and laboratory testing procedures to obtain data for use in drug development and clinical trials research.

RESPONSIBILITIES

• 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.

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

MINIMUM REQUIRED EDUCATION 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 preferred.

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