Quality Assurance Auditor

Requisition Number: 1604

Position Title: Quality Assurance Auditor

External Description:

SUMMARY: The QA Auditor is responsible for supporting QA Audits; inclusive of planning, executing, reporting, and following up. This individual would also support project management of audits and Regulatory Inspections as assigned.  

RESPONSIBILITIES:

• Champions and adheres to Worldwide’s Quality Management System (QMS)
• Serves as a positive ambassador of the QA organization with internal and external customers
• Develops and executes to personal and QA goals and objectives
• Adheres to Worldwide travel policy and QA budgets
• Performs QA audits for Vendors, Internal Process, Clinical Investigator, Document (Clinical Study reports, Trial Master File, Database) and other audits, as assigned
• Ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes, as assigned
• Participates in the driving continuous process improvements
• Participates in the development and review of the QA Audit and Inspection Program Quality Management Documents, as assigned
• Assists with tracking and reporting of Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program
• Provides support to Sponsors Audits and Inspections concerning Worldwide provided services, as assigned
• Ensures data and record management following the QMS
• Communicates relevant regulatory intelligence that has impact on the QMS to the QA team, if identified
• Participates in their performance appraisal as per Worldwide processes
• Performs other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

OTHER SKILLS AND ABILITIES:

• Ability to work remotely with minimal supervision and guidance
• Demonstrates good organizational skills and critical decision-making
• Strong project management skills
• Effective communicator that is concise, clear, and consistent to external and internal customers both verbally and in writing
• Demonstrated initiative and resourcefulness while working with a sense of urgency
• Demonstrated ability to prioritize work with some supervision

REQUIREMENTS:

• Good understanding of the principles for a GCP Quality Management System

• Working knowledge of the drug development lifecycle and Good Clinical Practice

• > 2 years QA or project management experience or combination of both
• Ability to speak, read and write English fluently
• M.S. in a scientific or allied health filed

OR

Completed university/college curriculum, or equivalent, with a concentration in nursing, biological, physical, health, pharmacy, or other related science.

• Experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint is an asset

• Domestic and international travel required (approximately up to 50%)

#LI-MS1

#IND-MS1

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Quality Assurance Auditor

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong:

CountryEEOText_Description: