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Job Title:  QC Laboratory Specialist (Aseptic Lab)

Req ID:  33138
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

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.

 

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.

Duties

  1. Decontaminates, cleans, and sterilizes glassware and other containers.
  2. Monitors and maintains laboratory equipment including calibration.
  3. Prepares media and reagents.
  4. Performs routine product and raw material testing of samples.
  5. Performs product and raw material testing of samples.
  6. Prepares reagents, standard solutions, equipment for use, etc.
  7. 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.
  8. Writes and revises standard operating procedures (SOPs) under supervisor’s direction, using Quality software to change, submit and review documents.

Participates in Investigations (complaints, failure, calibrations, equipment, etc.)

Education Degree

Bachelor's Degree

Required Experience

Number of years’ experience and type accepted in lieu of the above:

4 years experience required with Associate’s degree in a regulated industry (i.e. FDA / ISO13485)

Minimum 6 years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required without associates degree

Required Skills or Competencies

1. Ability to work in a fast-paced environment with strict deadlines

2. Empowerment:  Make recommendations on improvements to test methods and procedures

3. Decision Making:  Make decisions on experimental steps and data analysis within defined parameters and guidelines.

4. Problem Solving Authority: Recognize and communicates unexpected experimental results, Interpret data with direction.

 

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:  33138
Job Category:  Quality

St. Louis, MO, US, 63133


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