Microbiology Laboratory Technician

Duration : 7 months

Position will be for Thursday - Sunday 06:00 – 16:30 or 13:30 to 00:00

Objectives:

Conducts and performs a wide range of biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs. Position may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations.

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.