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
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