The Quality Assurance (QA) Manager has the authority for and responsibility of developing, implementing, and improving the laboratory Quality System that meets the requirements set forth in the Eurofins TestAmerica 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 performingsystems, data, special, and external audits with both clients and regulatory officials. The QA Manager oversees the maintenance of quality control (QC) records; maintains certifications; approves, develops, and maintains Standard Operating Procedures (SOPs); submits monthly QA Reports; and assists in reviewing new work as needed. The QA Manager 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 Manager is available to any employee at the facility to resolve data quality or ethical issues. The QA Manager is independent of laboratory operations.
Essential Duties and Responsibilities: Review Eurofins TestAmerica’s QMP and ensure compliance with the Eurofins TestAmerica QualitySystem Develop and implement the QAM Participate as a member of the laboratory’s senior management team. Act as the QA representative and a representative of senior management in clientmeetings, 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. As directed by the Laboratory Director,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 auditresponses 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 QualitySystem 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 compliancewith 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 equipmentcalibration, 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 causeanalysis investigations in response to audit findings, client complaints, training needsassessments, data recall events, etc. Recommend resolutions for ongoing or recurringnonconformance, and ensures implementation of appropriate corrective action Track revised reports, and assist in identifying systematic improvements to minimizeerrors 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 includebalances, weights, and thermometers Assist other laboratories as needed, including performing systems audits of otherEurofins TestAmerica laboratories
Education:BS/BA in Chemistry/SciencesExperience:Minimum 5 years bench level analytical experience plus formal QA training or 2 years QA experience.
Ability and/or Skills (BMQ):
Environmental methodologies General regulatory requirements Analytical laboratory techniques Laboratory QA requirements Statistical principles Knowledge of computers, spreadsheets, and databases Computer skills and databases Technical writing Organizational skills Time management skills Problem solving skills Strong communication skills Supervisory skills Ability to communicate effectively at all levels of organization, clients and outside agencies Analyze problems and effect solutions Ability to prioritize
EVOLUTION:In a fast growing group, successful leaders are frequently being offered increased areas of responsibility (subject to geographic mobility).Eurofins offers international opportunities to strong performers.