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.
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:
- Competitive salaries
- Healthcare benefits
- Tuition assistance
- Paid-time off
- Paid holidays
- Matching 401(k)
- Annual merit increases
- 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.
• 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.).
What Will Help You Be Successful
• Minimum 4 years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required without associates degree. Bachelor’s degree preferred.
• Ability to work in a fast-paced environment with strict deadlines.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.
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