QC Scientist- Plymouth, MN
6 months ago
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.
The Role
The Quality Control QC Scientist in our Plymouth, MN location is responsible for generating leading quality control initiatives with minimal supervision including second sourcing, developing test methods, and troubleshooting lab and product issues in accordance with the requirements for ISO, FDA QSR, and STERIS policies. Activities include laboratory testing, including incoming material and product verification, clean area monitoring, Environmental Monitoring (EM) Excursion and out of specification (OOS) reporting, developing test methodologies and validation methods, and audits.
What You Will Do
Assist with developing test methodologies and procedures Assists / trains Lab Techs and Specialist Works with QS on internal and external audits and audit training Assists with developing and validating methods Support and / or develop chemical testing procedures Support and /or develop technical requirements for raw material specifications based on input from potential vendors, product development staff, and process engineering Coordinate Failure Investigations by designing and performing lab scale simulation of products made in the plant Troubleshoots & calibrates Lab equipment Maintain and order lab supplies Lead: Assists with directing work of lab employees Lead: In supervisor’s absence will manage day to day operations including, scheduling, submit requisition to obtain lab supplies, and reviewing documentation
What You Will Need to Be Successful
Bachelor’s degree in relevant technical degree program (Chemistry, Biology or other relevant technical degree program). Minimum 6 years relevant lab testing in a regulated industry (. FDA/ISO13485) required. Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics. Ability to work in a fast-paced environment with strict deadlines. Ability to make recommendations on improvements to test methods and procedures. Must be able to make decisions on experimental steps and data analysis within defined parameters and guidelines. Ability to recognize and communicate unexpected experimental results to the supervisor, interpret data with minimal direction, participate in defining next step with supervisor, and retrieve information from scientific literature.
Working Conditions: Safety Sensitive Position
What STERIS Will 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, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter.
#LI-MO1
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.
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.
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