QA Associate

OMIC USA, Inc., Oregon

Job Description

Position Title: Quality Assurance Associate

Department: Quality Assurance Unit

Position Number: JD-023

Reports To: Quality Assurance Manager

FLSA Status: Non-Exempt

Prepared Date: Position Start or Revision of Current Duties

OMIC USA, Inc. is an international Analytical Laboratory and is committed to global food health and safety through the analytical testing services we offer to our clients.

MISSION OF THE ROLE:

The Quality Assurance Associate position supports the Quality Assurance Manager in the tasks required to verify regulatory compliance of all operations associated with the laboratory (e.g. sample receipt, processing, analytical, reporting, sales and human resources, etc.) with accreditation standards. (e.g. ISO/IEC 17025:2017) and contributes to the on-going development of the laboratory's quality management system. Based on experience, the Associate can take self-directed ownership for some QA tasks and contribute to quality management system continuous improvement.

Serves as QA Manager's backup as directed.

RESPONSIBILITIES:Other duties may be assigned.

Support the Quality Assurance Manager in maintenance and continuous improvement of the quality management system.

This includes but is not limited to:

Perform in-depth Internal Audits

Continuous improvement, and implementation of systems for compliance

Proactive document control to ensure all documents are within the system

Proficiency Testing; scheduling, reporting & follow up

Supplier qualification, and traceability

Perform internal audits of the quality management system to ensure compliance to the appropriate standards and accreditation programs and identify areas of non-conformance and/or areas for improvement.

Perform procedural audits of methods conducted in the laboratory against the appropriate SOPs and LABs to ensure accuracy of procedural documentation and adherence to laboratory procedures in the areas of analytical technique, QC and quality system compliance, including:

• reference material/solution tracking, reagents & solutions tracking, equip verification logs, instrument logbooks, training records, document control, and data package compliance.

Report audit details (observations, findings, non-compliances and non-conformances) to the Quality Assurance Manager and assist with resolution as applicable.

Supports the Quality Assurance Manager and assists in external audit activities as needed, including implementation of corrective action and improvements the Laboratory receives, as they relate to the quality management system.

Promote QAU information and QA training to laboratory staff, in meetings and as needed.

Periodically reconcile database records of Suppliers of externally provided products and services to the laboratory, to ensure qualification records are kept up to date; maintain supporting documentation and traceability in LIMS.

Records new laboratory equipment information in LIMS for unique identification and tracking purposes. Work with laboratory staff to ensure routine maintenance documentation is in place before use.

Coordinate and oversee internal & external calibration and verification of laboratory support equipment (pipette performance, temperature accuracy, etc.) The actual calibration/verification tasks may be performed by this position or other assigned laboratory personnel

• Coordinate external calibration and/or repair of equipment as needed. Communicate non-conformities to Quality Assurance Manager for course of action and/or data impact assessments.
• Maintain documentation of support equipment calibration both internal and external (hard copy, electronic and data base).

Ensure training of new lab personnel on operation and best practices for pipette use and handling, when applicable.

• The actual training tasks may be performed by this position or other assigned laboratory personnel, however this position is responsible for being a back-up trainer.

Assists the Quality Assurance Manager and laboratory staff by reviewing new or revised documentation for overall conformity with our internal policies and procedures as well as regulatory compliance, when applicable, prior to inclusion in the Document Control systems.

Ensure that routine maintenance/consumable replacement for residue water purification systems and on-site technician visits are scheduled as needed. Audit electronic water quality/use logs and records to ensure they are being maintained as needed. Ensure new personnel are trained in operation and best practices; serve as back-up trainer.

Periodically reconcile database records of reference materials and solutions to ensure that records are complete and accurate; maintain documentation of notification for corrections to be made by Chemists and traceability of completion. Ensure disposal of expired solutions (and neat as applicable). Periodically check physical neat standards and stock solutions for compliance (correct labeling, assigned physical locations, etc.) and maintain records of…