Example of a case study:
Client is attempting to get their medical device approved by FDA for market and clinical use. This requires chemical characterization by ISO 10993-18, a service offered by EAG Laboratories. Client sends the devices to EAG. The analytical team extracts the devices in various solvents, analyzes the extracts by LCMS and GCMS (and other techniques), and identifies all peaks (extractables) above a specified reporting limit. The extractables are ultimately assessed by a toxicologist for safety/risk. An individual in this role would be conducting the interpretation (identification) of the LCMS and/or GCMS extractable data. This would be high-throughput, moderate-paced, location-flexible work (primarily on-site, but able to be done remotely, as needed).
Example of equipment used:
Software relevant to LCMS and GCMS data interpretation:
Employees are expected to comply with ISO 27001 standard and company requirements for Information security.