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.

The Quality Assurance (QA) Associate will support QA processes, programs, and conduct QA activities. This position will uphold standards, methods, and procedures for all stages of production. This position will identify continuous process improvement areas, in compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GLP) processes and documentation for quality control activities. This requires excellent technical skills and abilities, analytical and mathematical skills, organizational and time-management skills, verbal, and written communication skills, plus ability to apply attention to detail.

• Implements company and quality standards for product manufacturing.
• Knowledgeable of industry and governmental quality regulations.
• Audits and reviews quality data according to existing procedures.
• Perform technical review of finished products and COA and label creation.
• Work with suppliers through technical inquiries and Supplier Corrective Action Reports.
• Assist in the maintenance of supplier performance monitoring.
• Perform / coordinate product inspection when applicable.
• Documents results in required format.
• Participate in risk management activities for processes and product.
• Files records of all quality processes.
• Assist in the process for implementing new and revised documents.
• Record Retention and Retrieval Activities, as required.
• Scanning of documents to be placed in archived folders, as required.
• Participate in company sponsored training
• Works on projects / matters of limited complexity in a supporting role.
• Work is closely managed.
• Performs other duties as assigned
• Ability to communicate orally in a clear manner.
• Able to view and operate a personal computer monitor or laptop screen, sit, stand or walk for long periods of time.
• Able to exert up to ten (10) pounds of force occasionally, and/or a minimal amount of force frequently to lift, carry, push, pull, or otherwise move objects.
• Able to work in fast-paced environment with a high-volume workload and frequent, short deadlines that may require more than a 40-hour work week to meet established deadlines.

• Bachelor’s degree from accredited institution in life science, chemistry, pharmaceutical science, statistics, or health/human services related field.
• Equivalent to 0-5 years of related professional experience
• A solid foundation of knowledge in Quality Assurance and Quality Management principles
• Knowledge of laboratory equipment, product use, and terminology
• Proficient with Microsoft Office Suite programs (Excel, Project, Word, etc.)
• Must be a team player and able to work collaboratively with and through others.
• Able to demonstrate commitment to compliance with applicable laws and regulations, the Company’s Ethics and Compliance Code of Conduct, and other Company policies and procedures and do so consistently.
• Demonstrate strong interpersonal skills and exceptional communication skills, both written and verbal, to clearly articulate messages to a variety of audiences
• Problem solving and root cause identification skills
• A strong understanding and demonstrated proficiency in Quality Management Systems (e.g., ISO and Quality System Regulations 21 CFR 820 and/or ISO 13485).
• An understanding of Risk Management principles and process (e.g., ISO 14971:2019)
• Able to work successfully in a team-based environment and build consensus for ideas. To support cross-functional task teams, committees and/or industry projects, either as leader or participant.
• Able to solve problems and make informed decisions, using knowledge, logic, and good judgment.
• Ability to read, write, and understand English.
• Travel Required 10%