Job Details
Performs various test procedures to determine the quality and uniformity of raw materials, in-process materials, and finished products in compliance with company specifications, quality standards and government regulations in support of the hard capsule business.
Performs, analyzes, and interprets microbial testing according to USP and regulatory requirements for raw materials, finished products, in-process samples, and stability.
Prepares and calculates stock cultures.
Performs investigations and completes CAPA in response.
Performs identification of microbial isolates.
Performs growth promotion.
Calibrates and verifies equipment.
Generates information for Core CoA for Imports and RGA(s).
Performs special projects.
Updates SOI(s) and WI(s).
Housekeeping of laboratory.
Media preparation, pH testing, sample collection, logging samples, and inventory supplies.
Environmental Monitoring (EM) which includes air, surface, personnel, and water.
Must be able to work 40 hours a week, which may include weekends, holidays, etc.
Must be able to work additional hours/days as business needs dictate.
Attendance in the plant site is considered an essential function.
The Microbiologist provides backup for other Microbiologists, as well as backup for Microbiology Analyst.
Perform other duties as assigned.