Senior QC Laboratory Specialist

STERIS•Saint Louis, MO

7d•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.

Requirements

Bachelor’s Degree
4 years of relevant lab testing experience in a regulated industry (IE: FDA/ISO13485)
Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis and statistics.
Ability to: work in aseptic environment and meet gowning requirements.
wear necessary Protective Equipment (PPE).
operate independently and resolve problems of low to moderate complexity, including moderate impact decisions.
initiate action to achieve project goals.

Nice To Haves

Bachelor’s degree in biology, microbiology, or other related degrees.
Expereince working in aseptic manufacturing (food, chemical, pharmaceutical etc.) environment.
Gowning and/or clean room experience.
Experience administering gowning assessments for other employees.
Strong verbal and written communication across departments, especially operations.

Responsibilities

Perform product and raw material testing of samples.
Preparation of reagents, standard solutions, equipment for use, etc.
Recognize and communicate unexpected results in a timely manner and complete 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.
Assists in writing validation protocols and reports.
Support and/or develop chemical testing procedures.
Support and/or develop 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.
Make recommendations on improvements to test methods and procedures.
Maintain and order lab supplies as needed.
Assist and trains Lab Techs and Specialists.