QC Lab Supervisor

Position Summary:

The QC Laboratory Supervisor 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 all aspects of quality control within the organization including receiving, in-process, finished goods testing, scheduling resources, defining solutions to improve compliance, and provide key input to senior management on compliance in accordance with the requirements for ISO, FDA QSR, and STERIS policies.

Schedule: Onsite 6am - 3:30pm Monday through Friday (on-call for 3rd shift 10pm - 6:30am)

Location: 7405 Page Ave St. Louis, MO

Pay: $79,687 - $103,125 annually + annual bonus

What You'll Do:

• Supervises laboratory activities to ensure all products are tested in accordance with company policy and Good Laboratory Practices.
• Supports NPD projects and completes all tasks related to the laboratory.
• Serves as a contact point for outside vendors, consultants and auditors.
• 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.

Skills, Abilities, and Experience:

Required:

• Bachelor’s degree.
• 8 years’ experience in a regulated industry (i.e. FDA/ISO 13485).
• 2 years of supervisory / leadership experience.
• 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.

Preferred:

• Bachelors in Chemistry or Biochemistry.
• Previous experience working in a regulated chemical manufacturing environment.
• Analytical laboratory expereince including using GC/HPLC/UPLC instruments/technology.
• Prior experience leading laboratory teams, including training, scheduling, and employee development.
• Experience supporting FDA, ISO, MDSAP, and customer audits within a regulated manufacturing environment.
• Demonstrated success leading investigations, CAPAs, nonconformance resolution, and root cause analysis activities.
• Experience supporting new product development, method validation, and continuous improvement initiatives.
• Knowledge of laboratory equipment qualification, calibration, and test method lifecycle management.
• Proven ability to manage multiple priorities while partnering cross-functionally with Quality, Regulatory, Manufacturing, Engineering, and R&D teams.

Other:

• Lifting, Pushing, Pulling 10-25lbs.
• Safety sensitive position.
• Working in a laboratory environment with exposure to chemicals.

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
• Excellent opportunities for advancement and stable long-term caree

Pay range for this opportunity is $79,687.50 - $103,125.00. [ACTION REQUIRED - REMOVE IF NOT APPLICABLE:] This position is eligible for bonus participation.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio.

Open until position is filled.

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 and life sciences products and services around the globe. For more information, visit www.steris.com.

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 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.