Quality Systems Specialist

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United States
San Mateo, California
Posting date: 31 May 2019

ProClinical is advertising a vacancy for a Quality Systems Specialist position with a leading pharmaceutical research company. The organization prides itself on its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. Based in the company's California office, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.

Job Responsibilities:

  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Participates in developing Standard Operating Procedures to ensure quality.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
  • Independently conduct, complete, and document critical, major, and minor investigations related to GxP operations.
  • Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.
  • Supports management and tracking of quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets.
  • Responsible for maintaining tracking tools/databases.
  • Responsible for sending periodic reminder notifications to leads/coordinators.
  • Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required.
  • Supports the maintenance and improvement to quality systems processes, as needed.

Skills and Requirements:

  • Bachelor's degree and 3 - 5 years of experience.
  • Knowledge of Root Cause Analysis, Deviations, and Corrective and Preventative Actions (CAPAs) is required.
  • Experience with investigation related to GxP operations is strongly preferred.
  • Experience writing and revising Standard Operating Procedures (SOPs) is strongly preferred.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Sherron Howard at +1 1 267 435 8600 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.