QC Laboratory Specialist

STERIS•Saint Louis, MO

7d•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. Position Summary: 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.

Requirements

Bachelor's degree
4 years experience required with an Associate’s degree in a regulated industry (i.e. FDA / ISO13485) in lieu of bachelor's degree.
Ability to work in a fast-paced environment with strict deadlines
Make recommendations on improvements to test methods and procedures
Make decisions on experimental steps and data analysis within defined parameters and guidelines.
Recognize and communicates unexpected experimental results, Interpret data with direction.

Nice To Haves

Advanced degree in Biology, Chemistry, or Biochemistry.
Experience working in retain room or similar environment.
Working experience of ERP systems like Oracle or AS400.
Previous experience using LIMS laboratory system.
Data review experience preferred.
Ability to cross train between chemistry, microbiology, and aseptic labs.

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.
Writes and revises standard operating procedures (SOPs) under supervisor’s direction, using Quality software to change, submit and review documents.
Participates in Investigations (complaints, failure, calibrations, equipment, etc.).