Job Type: Contract
Length: 6 months (renewable)
Job ID: 8184
The primary responsibility of this position is the performance of Environmental Monitoring (EM) tasks along with associated bio-analytical testing and reporting for the clinical production of cell therapy products.
Responsibilities will include, but are not limited to, the following:
Environmental Monitoring of cellular therapy production areas:
• Coordinate with Clinical Production staff for daily EM test schedule and activities.
• Collection of EM samples (air, surface and personnel) from controlled laboratory areas.
Aseptic gowning required for entry into controlled areas.
• Processing, incubation and evaluation of environmental test samples and incubation chambers.
• Organization and completion of EM documentation and entering of data into the EM database.
• Perform trend analysis and lot release reporting of EM data.
Analytical testing of cellular therapy products:
• Perform in-process and final product analysis of clinical release which includes cell counts, viability analysis, and subculture.
• Assist in analytical trouble shooting and investigations as needed.
• Update and maintain analytical data in DQC database.
Other essential DQC tasks include:
• Perform raw materials inspection and approval, including placental raw material.
• Perform routine control and calibration of DQC instruments and equipment.
• Participate in investigations as needed.
• Monitor DQC inventory of reagents and supplies. Re-order as needed.
• Other tasks as needed.
• B.S. degree (or equivalent) in Biochemistry, Biology or related discipline
• 0-1 year in a Quality Control laboratory or EM/Microbiology experience (manager is open to recent college grads)
• 1+ years in a Quality Control laboratory
• Cell culture experience
• Experience with environmental monitoring and aseptic processing Beneficial
• Proficient in Microsoft Word/Excel/Access