Quality Assurance Coordinator, Eurofins Environment Testing - Eurofins Environment Testing South Central, LLC

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.

Job Description

The Quality Assurance (QA) Coordinator reports directly to a QA Manager that has been assigned overall responsibility for Quality Systems at a facility. The QA Coordinator assumes the QA Manager role when the quality assurance manager is absent or unavailable at that facility. The Quality Assurance (QA) Coordinator has the authority for and responsibility of, implementing, and improving the facility's Quality System that meets the requirements set forth in the Eurofins Environment Testing America Quality Management Plan (QMP). Responsibilities include providing Quality Systems training to all new personnel; maintaining a laboratory Quality Assurance Manual (QAM); arranging and managing proficiency testing (PT) samples; and performing systems, data, special, and external audits with both clients and regulatory officials. The QA Coordinator oversees the maintenance of quality control (QC) records; maintains certifications; approves, develops, and maintains Standard Operating Procedures (SOPs); submits QA Reports; and assists in reviewing new work as needed. The QA Coordinator has the final authority to accept or reject data, and to stop work in progress in the event that procedures or practices compromise the validity and integrity of analytical data. The QA Coordinator is available to any employee at the facility to resolve data quality or ethical issues. As directed by the QA Manager, coordinates the activities of the QA staff.

Essential Duties and Responsibilities:

• Review Eurofins Environment Testing America's QMP and ensure compliance with the Eurofins
• Environment Testing America Quality System
• Work with the QA Manager to develop and implement the QAM.
• In the absence of or as directed by the QA manager, act as the QA representative and a representative of senior management in client meetings, regulatory meetings, open forums for discussing regulation changes, etc.
• In the absence of or as directed by the QA manager, act as a technical resource and final authority in all matters of data quality
• In the absence of or as directed by the QA manager, act as the focal point for ethics and data integrity issues.
• Conduct and/or oversee QA training courses. As directed by the QA Manger, may conduct ethics training minimally every quarter in which new employees are hired
• Evaluate the thoroughness and effectiveness of the laboratory's training program
• Perform system audits of each department, write audit reports, and approve audit responses
• Perform data audits
• Perform special audits as deemed necessary by data audits, client inquiries, etc.
• Conduct and respond to external audits conducted by clients and regulatory agencies
• Work with management in performing annual Management Review of the Quality System
• Assist in reviewing and/or writing of Quality Assurance Project Plans, and technical and QC specifications in contracts and proposals.
• Maintain all necessary laboratory certifications
• Manage scheduling, ordering, login, and reporting of PT samples
• Monitor new regulations, communicate them to the laboratory, and ensure compliance with the current version of regulations
• Review and approve laboratory SOPs. Write SOPs as needed
• Maintain historical indices of all technical records (e.g. SOPs, audits, ancillary equipment calibration, logbook distribution, etc.)
• Assist in and monitor laboratory's compliance with the reference methods, SOPs, and agency specific requirements
• Maintain training records, including Demonstrations of Capability (DOCs) for all analysts
• Assist in identification of systematic problems within the laboratory. Perform root cause analysis investigations in response to audit findings, client complaints, training needs assessments, data recall events, etc. Recommend resolutions for ongoing or recurring nonconformance, and ensures implementation of appropriate corrective