The Bioanalytical Specialist I will be involved in the analysis of bioanalytical specimens obtained from pre-clinical animal studies and clinical studies conducted at contract research organizations and work closely with the Principal Investigator/Lab Supervisor to ensure that these projects are completed in a timely fashion. The individual will be required to follow all Standard Operating Procedures (SOPs) and Test Methods (TSMs); Good Laboratory Practices (GLP) and internal processes.
Essential Duties and Responsibilities
Assist in development and validation of ICP-MS assays in a regulated environment and analyzing non-clinical and clinical study samples. Ensure the scientific quality of data in order to meet GLP/GCP regulatory expectation Participate in the analysis of bioanalytical specimens (e.g., blood, urine, tissues) Perform equipment qualifications and performance qualifications of temperature-controlled chambers Edit test methods and create other quality documents Follow cGMP and cGLP standards, TSMs and SOPs Calibrate analytical instrumentation Maintain supply inventory and SDS sheets, including requesting purchase orders Attend as necessary and successfully complete training on analytical instrumentation and procedures as well as other directed areas of interest Reports to Lab Supervisor any issues that may affect the identity, strength, quality, and purity of the product or that may improve the lab performance Troubleshooting of equipment Assist in research and development experiments when necessary Crosstrain with Quality Control to perform analytical characterization Performs other duties as assigned . Requirements:
Required Education and/or Experience
A Bachelor’s degree in the sciences is preferred. This position prefers one or more years of experience in a laboratory environment with experience with ICP-MS. Certification is not required. The employee shall be computer literate with excellent communication skills.
Must be able to work shifts in the following range:
6am-11pm