Senior Auditor, Quality Assurance IN OFFICE- AUSTIN

2 months ago

Texas, United States Worldwide Clinical Trials - USA Full time
Who we are

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us

What the Senior Auditor, Quality Assurance does

To have in-depth experience and working knowledge in appropriate GxP compliance and other applicable regulations in order to conduct various types of audits to assess Worldwide Clinical Trials Worldwide Clinical Trials processes and procedures, applicable regulations and Sponsor SOPs, when necessary. Provides guidance on regulatory compliance to internal clients. Provides direction and coordination of project activities related to assigned areas in liaison with QA management. Mentors other QA auditors. The Senior (Sr.) Quality Assurance Auditor works under the general supervision and guidance of the Manager, QA, Sr. Manager, QA, Director, QA or Sr. Director, QA.

What you will do
  • Works with the QA Management to plan, conduct and complete written reports for each audit assigned.
  • Monitors the projects and audit status in assigned areas and provides QA Management with current status upon request.
  • Assists with the management of the Vendor Audit program.
  • Facilitates sponsor audits/regulatory inspections, as assigned.
  • Assists QA Management with review of audit reports to identify improvements that enhance the quality and clarity of the reports.
  • Fosters a good working relationship with internal clients and QA team.
  • Identifies areas for process improvement and provides this information to management.
  • Assists with corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits.
  • Provides advice and guidance on regulatory requirements and SOPs.
  • Assists with training and mentoring of less experienced auditors.
  • Assists with creating and presenting GCP/GLP and other related training sessions.
  • Assists QA Management with review of policies and procedures.
  • Oversees the maintenance of records for each audit.
    What you will bring to the role
    • Sound knowledge of applicable GxP regulations and requirements as well as policies and procedures.
    • Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events.
    • Ability to use logical inferences to understand the "big picture" and long term implications of these issues.
    • Ability to interact professionally and to work independently or in teams.
    • Excellent oral and written skills.
    • Ability to prioritize work and define steps needed to achieve assigned project goals.
    • Ability so speak, read and write English fluently.
    • Experience with Microsoft Word applications and to learn internal computer systems as necessary

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