Scientist I, QC Microbiology

Overview:

The Scientist I will test and report cGMP test results for the Quality Control Microbiology Laboratory.

First Shift, Monday - Friday

Responsibilities:

• Follows current GMP requirements and complies with company safety and controlled substance handling policies.

• Participates in repair and maintenance of lab equipment and lab housekeeping (disinfection and cleaning).

• Initiates, documents and performs microbiological analysis on received test samples (including raw materials, bulk, final product, stability, water) as per USP, in-house or customer methods. Evaluates and records data under supervision.

• Performs environmental monitoring, as required; Evaluates and records data.

• Performs quality control testing of media, reagents, and identification materials.

• Maintains adequate inventory of media and materials required for testing.

• Notifies laboratory supervisor when OOS results are obtained; may assist with gathering data and documentation of notifications in TrackWise.

• May assist with special projects as needed.

• Performs data entry for tracking and trending of lab data.

• May assist with revising SOPs, forms and other controlled documents.

• Performs micro identifications using manual testing and automated systems.

• Flexibility in schedule is required.

Qualifications:

Bachelor’s degree in biology, health science or microbiology.

0-2 years’ experience in cGMP micro expertise.

Permanent