Coordinates and performs routine microbial testing of finished product, bulk in process, raw material, and stability, PET samples on second shift in accordance with compendial and in-house methods. And as needed, may perform some analytical testing.
Prepares stock cultures, media, plates, standards and solutions needed for microbiological testing.
Develops and performs environmental monitoring functions.
Ensures effective utilization of equipment over multiple shifts to allow for flexibility and adding capacity.
Orders (in conjunction with Purchasing) and maintains the chemical and consumable material inventory necessary to perform microbial testing
Performs routine maintenance, cleaning and calibration of equipment used in the micro lab.
Performs general housekeeping and organization of microbial working spaces according to GLP standards.
Performs routine physical and chemical testing of finished product, bulk in process, raw material, and stability samples in accordance with compendial and in-house methods.
Recommends and initiates testing protocols for special microbiological projects (R & D).
Performs peer review of analytical and/or microbiological notebooks, logbooks and other documents, as needed.
Initiates, revises and updates Analytical Methods and/or Standard Operating Procedures related to microbial testing.
Performs special projects, as assigned by the Manager, Quality Control, which enhance and contribute to the growth of the Quality Department
Performs and assumes other duties and responsibilities, as may be required by the Manager, Quality Control.
A 4-year degree in biology, microbiology or related discipline; or equivalent in training and experience.
The knowledge and skills required for this position are typically acquired in 3 to 5 years of work in a similar laboratory environment.
Experience working FDA regulated and/or GMP manufacturing environment.