QC Laboratory Specialist

1 week ago

St Louis, United States STERIS Full time
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

At STERIS, 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. The QC Laboratory Specialist 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. This position is eligible for a $2,500 signing bonus.

What We Offer You

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing the following:

• Competitive salaries
• Healthcare benefits
• Tuition assistance
• Paid time off
• Paid holidays
• Matching 401(k)
• Annual merit
• Annual bonus

What You Will Do

• 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.)

Education Degree
High School Diploma or GED
What Will Help You Be Successful
Minimum four (4) years' experience required with Associate degree in a regulated industry (i.e. FDA / ISO13485)
Minimum six (6) years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required without Associate degree.
Experience working an aseptic lab is strongly preferred.
Ability to work in a fast-paced environment with strict deadlines.

#LI-KL1

STERIS strives to be an Equal Opportunity Employer.

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