Quality Assurance Manager

Eurofins USA Environment Testing
Charlestown, RI Full Time
POSTED ON 3/26/2024 CLOSED ON 4/24/2024

What are the responsibilities and job description for the Quality Assurance Manager position at Eurofins USA Environment Testing?

Job Description

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 Environment Testing 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 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.

Quality Assurance Manager responsibilities include, but are not limited to, the following:

Lead team, schedule, and train employees

Ensure adherence to highest quality and efficiency standards in laboratory operations

Ensure coverage and performance

Foster morale and teamwork

Supervises QA Staff

Review Eurofins Environment Testing’s QMP and ensure compliance with the Eurofins Environment Testing Quality System

Develop and implement the QAM

Participate as a member of the laboratory’s senior management team.

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 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

Assist other laboratories as needed, including performing systems audits of other Eurofins Environment Testing laboratories

Act as the QA representative and a representative of senior management in client meetings, regulatory meetings, open forums for discussing regulation changes, etc.

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