QC Laboratory Specialist

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 in our Mentor, OH location 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 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, FTIR and/or UV Spectrophotometers) and with supervision to perform failure investigation.

This position requires working onsite in our Mentor, OH location. The hours for this role are  Monday through Thursday 6:00 am to 3:30pm and Fridays 6:00 am to 10:00 am.

What Youll do as a QC Laboratory Specialist

• 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 supervisors direction, using Quality software to change, submit and review documents.
• Participates in Investigations (complaints, failure, calibrations, equipment, etc.).

The Experience, Skills and Abilities Needed

Required:

• Bachelors degree in biology, chemistry or related technical field. 
• In lieu of a Bachelors degree, an Associates degree in biology, chemistry or related technical field, and a minimum of four years experience in a laboratory environment is required, preferably in a regulated industry (i.e. FDA / ISO13485).

Other:

• 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.

What STERIS Offers

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

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and 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 continuing education programs
• Excellent opportunities for advancement in a stable long-term career

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Pay range for this opportunity is $43,000 to $55,000. This position is eligible for bonus participation. 

Minimum pay rates offered will comply with county/city minimums, if higher than range listed.  Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio.  Click here for a complete list of benefits: STERIS Benefits

Open until position is filled.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity 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.