Job Description
Senior QC Laboratory Specialist - 2nd Shift
Req ID:
51565
Job Category:
Quality
Location:
Mentor, OH, US, 44060
Workplace Type:
Onsite
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 Senior 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 role is responsible for generating test methods, reports, and specifications for raw material, in-process, and finished goods in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to: investigating failures, executing validation protocols, and troubleshooting calibrated equipment.
What You'll Do as a Senior QC Laboratory Specialist
Assists and trains Lab Techs and Specialists.
Performs product and raw material testing of samples.
Prepares of reagents, standard solutions, equipment for use, etc.
Recognizes and communicates unexpected results in a timely manner and completed 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.
Assists in writing validation protocols and reports.
Supports and/or develops chemical testing procedures.
Supports and/or develops technical requirements for raw material specifications based on input from potential vendors, product development staff, and process engineering.
Coordinates Failure Investigations by designing and performing lab scale simulation of products made in the plant.
Troubleshoots & calibrates Lab equipment.
Maintains and orders lab supplies.
The Experience, Skills and Abilities Needed
Required:
Bachelor degree
Minimum 4 years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required.
Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics.
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 with shift differential
* 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
#LI-KL1
Pay range for this opportunity is$56,737.50- $70,087.50.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.
Req ID:
51565
Job Category:
Quality
Location:
Mentor, OH, US, 44060
Workplace Type:
Onsite
STERIS Sustainability
Life at STERIS
Nearest Major Market: Cleveland
Nearest Secondary Market: Akron
Job Segment:
Chemical Research, Testing, Laboratory, QC, Process Engineer, Engineering, Technology, Science, Quality
STERIS Corporation is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, sex, color, religion, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status.
