Quest Diagnostics
Senior Quality Assurance Specialist Clinical Trials
At a glance
Location: US-TX-Lewisville Map
Posted: 10/09/2021
Closing: 11/08/2021
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
Quest Diagnostics
Job description

Look for more than answers.

At Quest, we are on a continuous journey of discovery and development. It’s this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast-moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people.

As a Senior Quality Assurance Associate, Clinical Trials, you will work for the world leader in the industry, with a career where you will have the opportunity to collaborate and affect change while expanding your leadership skills and technical knowledge.

This professional will work on-site at Quest Diagnostics in Lewisville, TX, Seattle, WA or Marlborough, MA. 

Senior Quality Assurance Associate, Clinical Trials, the role:

This is the advanced level position in the Quality Assurance track. The Senior Quality Assurance Associate, Clinical Trials should demonstrate knowledge of regulatory requirements and exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria. This professional works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, may determine methods and procedures on new assignments, and may provide guidance to more junior personnel.

Job responsibilities:

  • Engages in planned and systematic activities to provide confidence that SCT is fulfilling its requirements for quality and continuous quality improvement.
  • Performs process-based inspections and conduct audits of laboratory and study records to ensure compliance with regulatory requirements and company standards.
  • Reviews policies and procedures. Recommends revisions to existing policies & procedures, or creation of new procedures.
  • Demonstrates and apply knowledge of QA regulations and best practices and help maintain a state of “continual inspection readiness”.
  • Assists manager and/or senior manager with preparation of department metrics and monitors
  • Conduct audits on a periodic basis according to an established schedule/annual audit plans.
  • Prepare written audit reports of all activities and report findings to Management and/or Study Director as applicable.
  • Reviews laboratory procedures and documentation for compliance with SOPs, protocols and applicable regulations.
  • Applies knowledge of GCP and GCLP on a daily basis, formally and informally.
  • Participate in development of, or develop annual audit and inspection plans frame.
  • Participates in the Quality Management Program.
  • Provides assistance to project and data management teams with NCEs, CAPAs and Complaints.
  • Perform and provide support for internal audits of computer systems, validation documentation, IT infrastructure and operations, and computer system vendors.
  • Advise Operations on system development issues, e.g. validation strategies, preparation and content of validation documentation etc.
  • Performs and provides support for internal audits of equipment qualification documentation including equipment qualification protocols test scripts (IQ, OQ and PQ) and summary reports for equipment qualification.
  • Advises staff on requirements and industry best practices regarding qualification requirements.  May review change control requests for qualified equipment and help staff to determine impact of change to the qualified state.
  • Assists with assessments of the impact of changes on qualified equipment.
  • Reviews clinical and nonclinical documents, protocols, study reports, dossier summary documents etc. for compliance with regulations.

To qualify, the ideal candidate will have the following skills and experience:

  • Bachelor's degree in a related scientific or technical discipline
  • 4+ years of experience in a QA role in a GLP or GCP environment
  • Knowledge of GCP and/or GLP and Quality Systems principles
  • Quality Assurance certification; e.g. RQAP-GCP; CQA preferred
  • Knowledge and experience in 21 CFR Part 11
  • Excellent verbal and written communication skills.
  • Exceptional interpersonal skills.
  • Strong influencing skills desirable
  • Demonstrated ability to manage multiple activities while maintaining a high level of organization.
  • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
  • Travel (10 – 20%). Occasional travel will be required to other Quest sites or to attend conferences.

Apply Today

Join us for competitive benefits and development opportunities in a progressive and supportive environment. Help us improve our service, and the experiences of our patients and colleagues. Work with us and together we can be better.

Your Quest career. Seek it out.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity or Citizenship. 

Senior Quality Assurance Specialist Clinical Trials