Quality Assurance Coordinator
2 weeks ago
The Quality Assurance Coordinator plays a critical role in ensuring the quality of our environmental testing services. Reporting directly to a QA Manager, this position assumes the QA Manager role when the manager is absent or unavailable. The Quality Assurance Coordinator is responsible for implementing and improving the facility's Quality System, which meets the requirements set forth in the Eurofins Environment Testing America Quality Management Plan (QMP).
Key Responsibilities:
- Provide Quality Systems training to new personnel
- Maintain a laboratory Quality Assurance Manual (QAM)
- Arrange and manage proficiency testing (PT) samples
- Perform systems, data, special, and external audits with clients and regulatory officials
- Oversee the maintenance of quality control (QC) records
- Maintain certifications
- Approve, develop, and maintain Standard Operating Procedures (SOPs)
- Submit QA Reports
- Assist in reviewing new work as needed
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
- Act as the QA representative and a representative of senior management in client meetings, regulatory meetings, open forums for discussing regulation changes, etc.
- Act as a technical resource and final authority in all matters of data quality
- Act as the focal point for ethics and data integrity issues
- Conduct and/or oversee QA training courses
- 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 action
- Track revised reports, and assist in identifying systematic improvements to minimize errors
- Track customer complaints and assists in identifying improvements
- Oversee and approve method detection limit (MDL) studies and verifications
- Generate and submit monthly QA reports
- Participates on QA conference calls
- Oversee generation of control charts and control limits, update of reference tables
- Perform or arrange for calibration of laboratory support equipment which may include balances, weights, and thermometers
- As directed by the QA Manager, assist other laboratories as needed, including performing systems audits of other Eurofins Environment Testing America laboratories.
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