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
• Abilityto wear PPE correctly most of the day.
• Ability tooperate heavy machinery
• Ability to adjust or move objects up to 50 pounds in all directions

Domestic travel - 10%

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [emailprotected].

BioMerieux 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 BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).