Senior 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 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.   

 

Location: 7501 Page Ave St. Louis, MO

Hours: Monday - Friday 8hr shifts that start between 4am - 9am central. Rotating Saturdays (full days) as needed. 

Hire Tpye: Direct. Full time. 

Pay: $29 - 33hr

What You'll Do:

• Perform product and raw material testing of samples.
• Prepare reagents, standard solutions, equipment for use, etc. 
• Recognize 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.
• Write and revise standard operating procedures (SOPs) under supervisor’s direction, using Quality software to change, submit and review documents.
• Assist in writing validation protocols and reports.
• Support and/or develops chemical testing procedures.
• Support and/or develops 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.
• Troubleshoot & calibrate Lab equipment.
• Maintain and order lab supplies as needed.
• Assist and train Lab Techs and Specialists as needed.

Skills, Abilities, and Experience Needed:

Required:

• Bachelors degree in related field
• 4yrs of relevant lab testing expereince in a regulated industry
• Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics. 

 

Preferred:

• Bachelors in Chemistry 
• Experience working in a Chemical Manufacturing environment 
• GCLC expereince
• Experience and ability to work both in a lab and manufacturing floor
• Ability and drive to meet tight deadlines and work quickly and accurately 

 

Other: 

• Ability to lift, push, and pull 10-25lbs as needed
• Hand & foot manipulation
• Visual acuity 

Competenecies

• Ability to work in a fast-paced environment with strict deadlines
• Empowerment:  Make recommendations on improvements to test methods and procedures
• Decision Making:  Make decisions on experimental steps and data analysis within defined parameters and guidelines.
• Problem Solving Authority: Recognize and communicates unexpected experimental results to the supervisor, interpret data with minimal direction, participate in defining next step with supervisor, and retrieve information from scientific literature

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 just a brief overview of what we offer:

 

⦁    Market Competitive Pay
⦁    Extensive Paid Time Off and (9) added holidays
⦁    Excellent Healthcare, Dental and Vision Benefits
⦁    Long/Short Term disability coverage
⦁    401(k) with company match
⦁    Maternity & Paternal Leave
⦁    Additional add-on benefits/discounts for programs such as Pet Insurance
⦁    Tuition Reimbursement and continued educations programs