QMS Specialist 1

Quality Management Systems Specialist

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 an administrator for batch record review, document control, training, and audits. The 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

• 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. 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
• 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 in compliance with company quality procedures and standards
• Performs other duties as assigned

Minimum Qualifications :

Knowledge, Skills and Abilities :

Physical Requirements :

Domestic travel - 10%

The estimated hourly wage range for this role based in Illinois is between $26.00 $36.50. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.

In addition, bioMrieux offers a competitive Total Rewards package that may include :

BioMrieux Inc. and its affiliates are Equal Opportunity / Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMrieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).