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Senior Quality Specialist, GCP Quality Assurance (QA)

Tempus

Tempus

Quality Assurance
Chicago, IL, USA
Posted on Saturday, March 16, 2024

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

Summary:

The Senior Quality Specialist is responsible for assisting in the coordination and implementation of Good Clinical Practice (GCP) related quality assurance activities. These responsibilities include supporting the execution and maintenance of the audit program focused on internal and external GCP audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, and Tempus Compass policies and procedures. The Senior Quality Specialist manages the tracking of audit findings, Corrective and Preventive Actions (CAPAs) and Non-conformances and assists with sponsor audits, as needed. The Senior Quality Specialist works with the QA Management and Department Heads to manage, assign and track training via the Learning Management System (LMS).

Job Responsibilities:

  • Collaborate with QA Management to implement the quality management system (QMS).
  • Coordinate and manage Tempus Compass policies, procedures and associated controlled documents throughout the development, review, revision and archiving process.
  • Ensure processes and procedures are updated to reflect regulatory trends, technological changes and best practices.
  • Track and perform follow up activities for audit findings, CAPAs and Non-conformances.
  • Compile trend analyses of GCP quality system metrics such as audit findings, CAPAs and Non-conformances and report to QA Management.
  • Assist in the preparation and conduct of internal and external audits as needed and ensure compliance with associated processes.
  • Support concurrent clinical efforts by consulting on projects and representing QA in interactions with internal and external customers.
  • Interface with clients, internal and external stakeholders, and vendors, as needed.
  • Support company regulatory GCP inspections, as needed.
  • Manage, assign and track corporate, regulatory, controlled document and project-specific training via the LMS.
  • Maintain the master training matrix and update upon release of new, revised or retired controlled documents.
  • Work closely with management to evaluate and identify trends and training needs.
  • Report metrics for corporate, regulatory, controlled document and project-specific training compliance trends to QA Management, Department Heads and Project Managers.
  • Support external controlled requests from sponsors or third party vendors.
  • Work effectively with cross-functional teams to address and resolve quality issues.
  • Performs other duties as assigned.

Demonstration of Tempus Compass Values:

Consistently strives to demonstrate the following Tempus Compass values:

  • Recognizes that the team is always stronger than the individual.
  • Seeks to inspire others by demonstrating consistently strong performance.
  • Treats people with respect regardless of role or point of view.
  • Listens well and seeks to understand before reacting.
  • Provides candid, helpful and timely feedback to colleagues.
  • Demonstrates curiosity about and contributes effectively to areas outside of their specialty.
  • Keeps the bigger picture in mind when making decisions.
  • Never stops learning.
  • Questions assumptions and offers suggestions for improvement.
  • Focuses on results rather than process and seeks to minimize complexity when process is required.
  • Identifies and addresses root causes, not symptoms.
  • Demonstrates poise in stressful situations.
  • Strives to always do the right thing.
  • Questions actions that are incongruent with Tempus Compass values.

Minimum Qualifications:

  • Bachelor’s degree required.
  • 5+ years of working and managing controlled documents and training in a regulated environment.
  • Experience working with QMS elements (e.g., document management, training and compliance, CAPA and non-conformance management, performing root cause analysis (RCA), and quality systems management).
  • Knowledge of ICH-GCP guidelines, and other applicable regulatory guidelines
  • Detail oriented with excellent communication and interpersonal skills, as well as the ability to interact at multiple levels of the organization, manage multiple priorities, and deliver high quality results.
  • Highly motivated individual with excellent problem-solving skills and the ability to make difficult decisions and provide sound Quality/Compliance direction to personnel as applicable.
  • Strong background in delivering quality results through effective planning and time management.
  • Ability to perform multiple tasks and manage changing priorities.
  • Proficient in Microsoft Office Suite (MS Word, Excel and PowerPoint).

Preferred Qualifications:

  • 8+ years of supporting a QMS in a Contract Research Organization (CRO) or Pharmaceutical company.
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We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.