Senior QC Lab Specialist (3rd Shift)

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.   

 

HOURS: 11pm - 7:30am Monday to Friday *overtime as business needs

LOCATION: 7405 Page Ave St. Louis, MO

PAY: $27.88 ($58,000) - $36.50 ($75,920) + $0.75 shift differential & bonus 

HIRE TYPE: Direct hire, Salaried-Nonexempt (eligible for overtime) 

What You'll Do:

• Perform product and raw material testing of samples.
• Preperation 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.
• 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 necessary.
• Assist and train Lab Techs and Specialists.

Skills, Abilities, and Experience:

Required:

• Bachelor's Degree and four (4) years relevant lab testing in a regulated industry 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.
  • Make recommendations on improvements to test methods and procedures.
  • Make decisions on experimental steps and data analysis within defined parameters and guidelines.
  • 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.
  • Operate independently and resolve problems of low to moderate complexity including moderate impact decisions. Initiate action to achieve project goals.

 

Preferred:

• Previous work in FDA and/or ISO13485 regulated industry.
• Experience woeking with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable standards.
• Bachelor's degree in Chemistry, Biochemistry, or scientific field with a strong chemistry emphasis or minor.
• Previous quality work experience in a manufacturing or chemical manufacturing environment. 
• GCLC experience in previous roles.
• Strong ability and experience problem solving and working independently.

 

Other:

• Ability to work in a laboratory setting with exposure to chemicals.
• Physical Requirements:
  • Lift, Push, Pull between 10 - 25lbs at a time
  • Bending, Walking, Standing, Sitting, Typing, Hand Manipulation, Visual Acuity.

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:

 

• Extensive Paid Time Off and (9) added holidays
• Excellent Healthcare, Dental and Vision Benefits after
• Long/Short Term disability coverage
• 401(k) with company match
• Maternity & Paternal Leave after 1yr
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Tuition Reimbursement and continued educations programs
• Excellent opportunities for advancement and stable long-term career

Pay range for