Senior QC Lab Specialist (3rd Shift)

STERIS•Saint Louis, MO

1d•$58,000 - $75,920•Onsite

About The Position

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)

Requirements

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

Nice To Haves

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.

Responsibilities

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.