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Quality Assurance Opportunities at Parexel

By being hired into one of our Quality Assurance jobs at Parexel International, you’ll be a key member of the Parexel International team. Professionals in Quality careers come from a variety of backgrounds, bringing an assortment of knowledge and skills to every area of our business. A job in Quality at Parexel International may be waiting for you!

Audit Coordinator

Job ID 51427BR Billerica, Massachusetts
The Audit Coordinator provides guidance and helps to facilitate the effective preparation, management and follow up of Sponsor Audits and Regulatory Inspections.

Key Accountabilities:
  • Work with Global team members to coordinate Sponsor audits; including: preparation meetings, audit agendas, etc.
  • Collaborate with Sponsors (as assigned) to coordinate audits
  • Arrange with other departments to gather necessary information on Sponsor confidentiality agreement documentation.
  • Assist in follow up and consultancy with clients, PAREXEL management, and staff.
  • Build, develop, and maintain good working relationships with internal and external customer groups
  • Travel on assignment if needed

Support the management of sponsor audits and regulatory inspections:
  • Act as a contact with members of Regulatory Authorities and help support inspections in agreement with QA management
  • Support the data entry of audit and inspection information into the SAIG database, i.e. collection, QC and coordination of documents to be entered

Education:
  • BA/BS degree preferred or relevant experience

Qualifications

Skills:
  • Ability to develop relationships with a culturally diverse group of key stakeholders within PAREXEL and the client’s business
  • Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions
  • Experience with Microsoft based applications and ability to learn internal computer systems
  • Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
  • Ability to work flexibly and adjust to changing priorities and unforeseen events
  • Diplomatically address sensitive issues confidentially and professionally
  • Excellent knowledge of, and working experience with, relevant national / international regulations
  • Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups
  • Work professionally with highly confidential information
Knowledge and Experience:
  • Significant experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area
Education:
  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience

EEO Disclaimer

PAREXEL is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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