• Quality Control Laboratory Specialist

    Steris Corporation (Mentor, OH)


    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

    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.

     

    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.

     

    What You'll do as a QC Laboratory Specialist

     

    + Decontaminate, clean, and sterilize glassware and other containers.

    + Monitor and maintain laboratory equipment including calibration.

    + Prepare media and reagents.

    + Perform routine product and raw material testing of samples.

    + Perform product and raw material testing samples.

    + Prepare reagents, standard solutions, equipment for use, etc.

    + Recognize and communicate 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.

    + 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.).

     

    The Experience, Skills and Abilities Needed

    Required:

    + Associate degree with scientific focus.

    + Minimum one (1) year experience relevant lab testing in a regulated environment (i.e. FDA/ISO 13485).

    + Minimum four (4) years' experience relevant lab testing in regulated environment accepted in lieu of degree.

     

    What STERIS Offers

     

    We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.

    Here is a brief overview of what we offer:

    • Market Competitive Pay

    • Extensive Paid Time Off and (9) added Holidays

    • Excellent Healthcare, Dental and Vision Benefits

    • Long/Short Term Disability Coverage

    • 401(k) with a company match

    • Maternity and Paternity Leave

    • Additional add-on benefits/discounts for programs such as Pet Insurance

    • Tuition Reimbursement and continued education programs

    • Excellent opportunities for advancement in a stable long-term career

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    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.

     

    If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

     

    STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

     

    The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location's HR Office during normal business hours.

     

    Req ID: 48964

     

    Job Category: Quality

    Location: