Quality Control Analyst

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision.

Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting‑edge solutions to tough problems.

Responsible for supporting Meridian’s Quality Policy and operating procedures through an active role in Incoming Materials and Finished Product Inspection processes, utilizing QC equipment and completing the appropriate paperwork in alignment with Good Documentation Practices. Support the maintenance and improvement of the Quality Management System through participation in the Internal Audit program and the CAPA process. Manage document changes and new document initiations within Magellan’s Document System under the supervision of senior Documentation staff.

A heavy emphasis on documentation and process controls in compliance with current Quality System Regulations and ISO standards is required.

Major Duties and Responsibilities

• Responsible for technical inspection of incoming materials.
• Review qualification testing of materials, components and equipment in support of manufacturing operations.
• Assist in preparing for audits and documenting audit status.
• Perform internal audits to ensure processes comply with company procedures, ISO 13485 and 21 CFR Part 820 requirements.
• Issue audit findings that identify procedural weaknesses or process deficiencies and provide recommendations for improvement.
• Perform root‑cause investigations to determine appropriate closure routes for internal audit findings.
• Maintain CAPA progress charts to ensure CAPAs are addressed according to stated schedules and timelines.
• Support Quality KPI and Management review by tracking progress on QMS activities and ensuring production quality metrics are obtained and reviewed for presentation and documentation.
• Perform administrative review of Engineer Change Orders and input ECO documentation into the Electronic Quality Management System.
• Write and/or revise procedures related to quality assurance processes.
• Other duties as assigned.

• Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, lab coat, etc.).
• Must be able to adhere to applicable biosafety practices when on the manufacturing floor.
• Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
• Must be able to analyze, concentrate, and solve complex issues throughout the workday.

• Minimum Education or Equivalent Experience Required/Preferred:
  Bachelor of Science Degree with 0–2 years of experience or demonstrated success within operational area with 2–4 years of related experience required.

• Understand principles of Quality Management System, including requirements of Current Good Manufacturing Practice (CGMP), Good Documentation Practice (GDP), Good Laboratory Practice (GLP), Quality System Regulation (QSR), United States Department of Agriculture (USDA), and International Organization for Standardization (ISO) 13485.
• Excellent working knowledge of CGMP, QSR, GLP, and ISO regulations.
• Proficient in Microsoft Word and Excel.
• Practical knowledge of gauge management and qualification.
• Ability to conduct product or process quality investigations.
• Extensive experience with inspection and specification procedures is preferred.
• Ability to interact in internal and external audits and act as a role model for the QC department.
• Detail and process oriented.

• Not anticipated. However, must be able to travel by car/air to other MBI locations and/or supplier locations as needed.
• All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status (USA Only).