QMS Specialist 1

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.

Primary Duties

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

Minimum Qualifications: 

• High School Diploma, GED or equivalent required
• 4 years of experience in quality management
  • Background with implementation of process improvement programs
  • Ccomputer skills including Microsoft Office Suite
•  Knowledge of ISO 9001 preferred.

Knowledge, Skills and Abilities: 

• Detail orientation to complete 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 to complex 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

Physical requirements:

• 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

Domestic travel - 10%