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Job Title:  Senior QC Laboratory Specialist

Req ID:  27838
Job Category:  Quality

St. Louis, MO, US, 63133

Description: 

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 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.   

Duties

  • Perform product and raw material testing of samples
  • Preparation of reagents, standard solutions, equipment for use, etc.
  • Recognize and communicate 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
  • Write and revise standard operating procedures (SOPs) under supervisor’s direction, using Quality software to change, submit and review documents
  • Assists in writing validation protocols and reports
  • 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
  • Assists / trains Lab Techs and Specialists

Required Experience

 

Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics.

4 years’ experience in a regulated industry (i.e. FDA/ISO 13485).

 

Education Degree

Bachelor's Degree in Science

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 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:  27838
Job Category:  Quality

St. Louis, MO, US, 63133


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