Home Based, US

As a Quality Specialist I you will provide quality oversight support to project team management throughout assigned projects. Specifically responsible for the conduct of remote quality evaluations to proactively identify and address potential quality risks or issues, quality consultation, CAPA support, audit and inspection support. Communicate results to the project team (PM, PL, FLs). As assigned collecting, reviewing and reporting of project quality metrics.

• Perform, report, and coordinate the quality evaluations for assigned projects.
• Verify compliance with GxP guidelines/regulations, Parexel procedures and requirements, and sponsor requirements.
• Review key project documentation and provide feedback to the project team.
• Actively participate in key internal project team meetings and facilitate quality discussions during these meetings.
• Schedule project related Quality meetings as needed.
• Provide quality consultation support to project teams.
• Provide support with investigation of Quality Issues (QIs) and support of QI management including classification, root cause analysis, consultation on appropriateness of corrective and preventive actions, as assigned.
• Identification of process gaps and/or improvement opportunities.
• Work closely with Operational management and with Line Manager to ensure continuous process improvement, as assigned.
• Establish and maintain good and efficient communication lines within Project Quality & Risk Management (PQRM), Operations staff and other Quality and functional departments, as appropriate.
• Adhere to adequate communication and/or escalation processes within Project Quality & Risk Management (PQRM) and other Quality/Operational/Functional departments, as applicable
• Perform, report, and coordinate the quality evaluations for assigned projects.
• Verify compliance with GxP guidelines/regulations, Parexel procedures and requirements, and sponsor requirements.
• Review key project documentation and provide feedback to the project team.
• Actively participate in key internal project team meetings and facilitate quality discussions during these meetings
• Provide quality consultation support to project teams.
• Provide support with investigation of Quality Issues (QIs) and support of QI management including classification, root cause analysis, consultation on appropriateness of corrective and preventive actions, as assigned.
• Participate in relevant project team training.
• Identification of process gaps and/or improvement opportunities.
• Report process gaps and participate in implementation of process improvement.
• Work closely with Operational management and with Line Manager to ensure continuous process improvement, as assigned.
• Maintain an understanding of Parexel standard operating procedures that are relevant to the assigned project(s) and of relevant regulations and guidelines.
• Establish and maintain good and efficient communication lines within
• Project Quality & Risk Management (PQRM), Operations staff and other Quality and functional departments, as appropriate.
• Adhere to adequate communication and/or escalation processes within Project Quality & Risk Management (PQRM) and other Quality/Operational/Functional departments, as applicable.
• Maintain a familiarity with Parexel project-related systems and related processes.
• Remain informed about developments in relevant regulations and guidelines.
• Excellent interpersonal, verbal and written communication skills with Client focused approach
• Assist in the maintenance of the relevant website, Parexel Connect page and PMED filing areas, as needed.
• Support developing training materials and/or deliver training related to Project Quality & Risk Management (PQRM) activities

Skills

• Excellent interpersonal, verbal & written communication skills
• Client focused approach
• Ability to work independently, take initiative and have flexible approach with respect to work assignments.
• Detail oriented
• Ability to manage multiple and varied tasks
• IT literate and proficiency with Microsoft applications
• Able to travel less than 5%

Education

• Educated to degree level (technology, life sciences, biological sciences, pharmacy or other health related discipline preferred) or equivalent qualifications or clinical research experience