Quality Control Laboratory Specialist -2nd Shift (Mentor, OH, US, 44060)

Steris Corporation•Mentor, OH

36d•Onsite

About The Position

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The QC Laboratory Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This position is responsible for performing quality inspection in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to testing raw material, in-process, and finished goods using the various analytical instrumentation (i.e. HPLC, GC) and with supervision perform failure investigation. This is a second shift position. Will train Monday - Friday 2:00pm-10:30pm. Will move to Monday - Friday 4:00pm-12:30am when training is complete.

Requirements

Associate degree
Minimum four (4) years experience relevant lab testing in a regulated environment (i.e. FDA/ISO 13485). Will accept less years of experience and lab testing in an academic setting with Bachelor degree.

Responsibilities

Decontaminates, cleans, and sterilizes glassware and other containers.
Monitors and maintains laboratory equipment including calibration.
Prepares media and reagents.
Performs routine product and raw material testing of samples.
Performs product and raw material testing of samples.
Prepares reagents, standard solutions, equipment for use, etc.
Recognizes and communicates unexpected results in a timely manner and completes Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials.