Perform aspects of laboratory instrumentation including maintenance, calibrations and performance verification's in compliance with cGMP and regulatory requirements.
Essential Duties and Responsibilities
• Perform routine maintenance and qualification of instrumentation.
• Accountable for documenting all activities and maintaining records according to good documentation practices.
• Accountable for proper use, care, troubleshooting and maintenance of instrumentation.
• Perform installation qualification on typical instrumentation (HPLC, GC).
• Provide detailed accounts of testing performed to investigators. Under the direct supervision of an investigator, may perform investigational testing.
• Participates in required monthly safety trainings and annual HAZ-COM, RCRA and API handling trainings. Hazardous waste involvement may include but is not limited to making waste determinations, generation, transportation, satellite accumulation, storage and disposal of multiple types of waste streams, and container management and inspections.
- Experience in a government regulated laboratory environment, preferably for drugs or medical devices including cGMP, GLP and ICH and their application to laboratory testing and review processes and procedures.
- Bachelor’s degree in scientific discipline, preferably in Chemistry or Biochemistry.
- Two or more years of experience in an analytical laboratory position.
- Interest and availability for working 2nd shift, 2:00 - 11:00 PM, Monday - Friday.
- Ability to use and maintain analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers.