Job Description
Job Description
Job Description
Job Function and Description
Identified responsibilities include:
• Collect samples from manufacturing areas to evaluate environmental classification or critical utility integrity.
• Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at the company manufacturing facilities, etc.
• Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system). Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Complete all testing, including special project/protocol testing in a timely and appropriate manner.
• Initiate and obtain applicable approval for test requests.
• May maintain inventory/supplies necessary to conduct routine testing.
• Follow continuous improvement practices (QLP, 5S, LEAN, etc.)
• Performs equipment maintenance and calibrations as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
• May perform other duties as assigned.
· Education and Experience Requirements
• Typically requires bachelor's degree in chemistry, biological science, or other related technical field. Some related work experience preferred.
Microbiology:
- Environment monitoring, critical utility sampling, endotoxin testing, bioburden for raw materials and in process, process samples, microbial identification and final product sterility testing.