QMS Specialist 1

Biofire Diagnostics•Lombard, IL

80d•$26 - $37

About The Position

The Quality Management Systems Specialist will work with site employees to ensure bioMerieux's standards and requirements are met for various Quality systems. The position will act as administrator for batch record review, document control, training, and audits. Specialist will also support in thepletion of higher criticality Quality tasks such as Quality Events, CAPAs, and metrics in association with bioMerieux's policies.

Requirements

High School Diploma, GED or equivalent required
4 years of experience in quality management
Background with implementation of process improvement programs
puter skills including Microsoft Office Suite
Detail orientation toplete tasks without errors and produce high-quality
Critical thinking, using logic and reason to analyze information and make decisions in the workplace
Problem solving to find solutions toplex business challenges
Strong interpersonal skills and great attention to detail are necessary
Ability to manage indirect relationships and project successfully
Elevate issues to management, when appropriate
Must be able to handle multiple projects concurrently
Ability to remain in stationary position, often standing, for prolonged periods
Ability to ascend/descend stairs, ladders, ramps, and the like
Ability to wear PPE correctly most of the day.
Ability to operate heavy machinery
Ability to adjust or move objects up to 50 pounds in all directions

Nice To Haves

Knowledge of ISO 9001 preferred.

Responsibilities

Perform Quality review of lot batch records for good documentation requirements and paperwork meets process specifications for product release
Coordinate Change Request workflows and publish controlled documents within Document Control system, LLDC.
Performs initial review of all Corporate driven procedure changes and manages Corporate Document Change Impact process
Oversee the learning management system. Logpleted training, generate reports and optimize training requirements for management
Supports site continuous improvement activities
Supports activities related to Quality Events and CAPA activities
Coordinates internal and external audit schedule with stakeholders
Provides input for improvement in the Quality Management System
Support Quality Engineers with determination of Key Performance Indicators
Perform all work inpliance withpany quality procedures and standards
Performs other duties as assigned

Benefits

A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves