Quality Assurance Associate

Meridian Bioscience • Memphis, TN

349d

About The Position

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.

Requirements

• 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.
• Able to solve problems and make informed decisions, using knowledge, logic, and good judgment.
• Ability to read, write, and understand English.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees