Assoc, Quality Sr - Clinical Trials

Quest Diagnostics•Seattle, WA

9d•$95,000 - $130,000

About The Position

This is the advanced level position in the Clinical Trials Quality Assurance track. Demonstrates knowledge of regulatory requirements and exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May determine methods and procedures for new assignments and provide guidance to more junior personnel. Performs duties and responsibilities with minimal supervision. Engage in planned and systematic activities to provide confidence that Pharma Services Biopharma team is fulfilling its requirements for quality and continuous quality improvement. May perform audits of laboratory and study records to ensure compliance with regulatory requirements, company standards, and study plans/protocols. Reviews policies and procedures. Demonstrate and apply knowledge of applicable regulations and industry guidance/standards (e.g., GCP and GCLP) and best practices and help maintain a state of “continual inspection readiness”. Apply knowledge of GCP and GCLP and quality management system principles on a regular basis, formally and informally.

Requirements

Demonstrates knowledge of regulatory requirements
Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria.
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
May determine methods and procedures for new assignments and provide guidance to more junior personnel.
Performs duties and responsibilities with minimal supervision.
Knowledge of applicable regulations and industry guidance/standards (e.g., GCP and GCLP) and best practices

Responsibilities

Engage in planned and systematic activities to provide confidence that Pharma Services Biopharma team is fulfilling its requirements for quality and continuous quality improvement.
May perform audits of laboratory and study records to ensure compliance with regulatory requirements, company standards, and study plans/protocols.
Reviews policies and procedures.
Demonstrate and apply knowledge of applicable regulations and industry guidance/standards (e.g., GCP and GCLP) and best practices and help maintain a state of “continual inspection readiness”.
Apply knowledge of GCP and GCLP and quality management system principles on a regular basis, formally and informally.