QMS Specialist 1

bioMérieux • Lombard, IL

6d • $27 - $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 the completion 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.
• 5+ years of related experience in a manufacturing regulated industry.

Nice To Haves

• Background with implementation of process improvement programs.
• Strong computer skills including Microsoft Office suite.
• Knowledge of ISO 9001 preferred.
• Experience with SAP a plus.
• Experience in Quality, preferably with a GMP.

Responsibilities

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees