Immunoassay Associate Scientist

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.

Minimum Education and Experience

• Bachelor's Degree Req or Other equivalent combination of education, training and experience.
• Bachelor's Degree Some CAP/CLIA lab locations may require a BS in chemistry, biology, or medical laboratory technology degree Req
• 6 months of experience in a regulated laboratory environment.

Required Responsibilities
• 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 Req