QC Laboratory Specialist

STERIS•Plymouth, MN

7d•Onsite

About The Position

This position is responsible for performing microbiological quality testing and inspections in accordance with ISO standards, FDA Quality System Regulations (QSR), and STERIS policies and procedures. Responsibilities include the analysis of raw materials, in-process samples, and finished products using microbiological methods such as bioburden, environmental monitoring, microbial identification, and sterility testing, while assisting with contamination investigations and root cause analysis under supervision.

Requirements

Bachelor's Degree OR Associates Degree + 4 years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required without associates degree.
Ability to work in a fast-paced environment with strict deadlines
Ability to make recommendations on improvements to test methods and procedures
Ability to make decisions on experimental steps and data analysis within defined parameters and guidelines.
Ability to recognize and communicate unexpected experimental results, interpret data with direction.

Nice To Haves

Bachelor's Degree in Biology, Microbiology, or similar.
Experience with plating, filtration, endotoxin testing, and aseptic technique.
Previous lab experience.
Experience collecting samples on manufacturing floor.

Responsibilities

Decontamination, cleaning, and sterilization of glassware and other containers
Monitoring and maintenance of laboratory equipment including calibration
Preparation of media and reagents
Perform routine product and raw material testing of samples
Perform product and raw material testing of samples
Preparation of reagents, standard solutions, equipment for use, etc.
Recognize and communicate unexpected results in a timely manner and completed Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials
Write and revise standard operating procedures (SOPs) under supervisor’s direction, using Quality software to change, submit and review documents
Participate in Investigations (complaints, failure, calibrations, equipment, etc.)