Specialist, QA/Compliance/Safety- Seattle, Washington

Basic Purpose:

Our goal is to provide every patient and every customer with services and products of superior

quality.

We do that through commitment, leadership, and establishing rigorous processes which

we measure and continually improve upon.

The lab is moving in Feb 2022 to this new address: 1737 Airport Way S Suite 200, Seattle, WA 98134.

Duties and Responsibilities:

The QA Specialist position is intended to provide oversight and support for the Quality Program-Quality Management Planning, inspection preparedness and responses associated with laboratory accreditation, non-conformance management and Document Control management, and training and competency monitoring.

I.

Work with the Laboratory Director and Department Supervisors to facilitate the Quality Management Planning process.

a.

Identify and monitor quality indicators.

b.

Schedule and conduct Quality Meetings and distribute the minutes.

II.

Ensure inspection preparedness by conducting internal audits of laboratory processes to identify non-conformances and areas of needed improvement.

a.

Appropriate Authorization, Delegations, and associated Performance Assessments

b.

Training and Competency documented via MediaLab.

c.

Testing Exceptions

III.

Effectively create and complete Corrective and Preventive Actions (CAPAs) for areas where non-conformances are identified.

a.

Immediate Corrective Actions

b.

Preventative Actions with Patient Remediation

c.

Continuous monitoring and Effectiveness Checks

IV.

License Coordinator for accreditation licensure.

V.

QA Record organization and adherence to record retention requirements.

VI.

Responsible for management of the CAP website as applicable for the organizational profile as well as testing and supervisory personnel.

VII.

SmartSolve Software Administration for Document Control.

a.

Manage SOP Life Cycle (Implementations, Recurring Reviews, Administrator monitoring reports).

VIII.

Quality metrics data collection and analysis to identify trends and needed interventions.

IX.

Other duties as assigned.

Supervision Exercised:

None

Qualifications:

• Bachelor’s Degree (Medical Technology or Chemical, Biological, or Clinical Laboratory Science)

• At least three years’ experience and associated knowledge of Laboratory regulations (CMS/CAP/NYS) and accreditation processes in a Medical Laboratory-Clinical or Anatomic Pathology.

• At least 1 year of Good Clinical Research Practice (GCP) experience is preferred.

• Lean Six Sigma (Continuous Improvement) experience preferred

• PC application skills in Microsoft Office including Excel and Access.