Job Description

The Quality Assurance (QA) Specialist is responsible for performing internal audits, assisting with external audits, overseeing the maintenance of QC records, certifications, review and revision of Standard Operating Procedures (SOPs), training records, Demonstrations of Capability (DOCs), arranging and managing proficiency testing (PT) samples. Additional responsibilities may include investigating systematic problems within the laboratory, assisting in writing client-facing CARs, and other functions in support of the QA Manager's responsibilities as assigned.

Essential Duties and Responsibilities

As assigned by the QA Manager, the duties and responsibilities may include all or some of the following items:

Conduct group meetings

Perform data audits

Perform audits for client inquiries, etc.

Assist in conducting and responding to external audits conducted by clients and regulatory agencies

Review Quality Assurance Project Plans, and technical and QC specifications in contracts and proposals

Assist in maintaining laboratory certifications

Assist in arranging and manage scheduling, ordering, login, and reporting of PT samples

Monitor new regulations and communicate them to the laboratory

Review and write SOPs

Maintain historical indices of technical records including SOPs, QC records, laboratory data, 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 laboratory and recommend resolutions for ongoing or recurring nonconformance

Track customer complaints and assist in identifying improvements

Oversee and review MDL studies

Generate control charts, control limits, and update LIMS

Perform or arrange for calibration of laboratory support equipment