Description

Position Summary

The Quality Specialist is responsible for performing physical inspection of card batches on the production floor, supports quality walkthroughs of production areas and changeovers between batches (as applicable), and supports preperation of performance testing facilitated through microbiological laboratories.

Primary Duties

• Utilize AQL sampling guidance to inspect cards, pouches, and cartons for physical anomalies or rejects.
• May support containment of quarentined or rejected materials.
• Supports nonconformance investigations using Root Cause Analysis tools (i.e. 5 WHYS, 5M+E, Is/Is Not, etc.) as required.
• Perform walk-throughs to support technicians in comments, quality decisions, and procedure questions.
• Implements and completes continuous improvement projects as required.
• Collaborate with Final QC lab and multiple department bodies for card inspection results.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Qualifications

Required Education, Training and Experience

• High School Diploma, GED or equivalent
• 3+ years of related experience in an FDA manufacturing environment and/or quality manufacturing

Preferred Education, Training and Experience

• Bachelor's degree 
• Experience working in a GMP environment
• Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR).
• Prior knowledge of MES, SPC, or SAP a plus

Knowledge, Skills, and Abilities (KSAs)

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Written Communications - including the ability to communicate technical data in written form
• Effective verbal communication skills
• Participate in a way that enhances team performance and cohesion.
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
• Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance

Supervisory Responsibilities (Summary)

This position has no direct or indirect supervisory responsibilities. The role operates independently on operational and tactical decisions affecting immediate outcomes and daily team performance, while strategic decisions that influence future direction, sustainability, and alignment with bioMérieux’s mission require supervisory review and approval.

Supplemental Data (Summary)

Makes operational or tactical decisions affecting immediate outcomes and daily team performance with little-to-no supervisory review.

Strategic decisions influencing future direction, sustainability, and alignment with bioMérieux’s mission require supervisory review and approval.

Working Conditions (Summary)

• Ability to remain in stationary position, either sitting or standing, for prolonged periods.
• 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 required: 5% of time.
• International travel required: 0% of time.
• Total travel required: 5% of time.

Reports To: Associate Manager On Floor Support Quality Operations

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