Quality Assurance Assistant

Summary

Join our dynamic team as we bring together more than 2,700 driven individuals to change lives and bring new medicines to those who need them. As a key member of our organization, you will be responsible for interacting with project teams, company divisions, and offices to ensure quality assurance and maintenance of internal and external systems.

Requirements

• College or university degree
• Clinical research industry experience is a plus
• Experience working in a GxP setting a plus
• Advanced proficiency in MS Office (Word, Excel, Power Point, Outlook)
• Strong oral and written communication skills
• Ability to handle basic office equipment
• Good formatting and proofreading skills

Responsibilities

• Interaction with project teams with regard to quality assurance (QA) study audits scheduling and preparation
• Interaction with company divisions with regard to internal systems audits scheduling and preparation
• Interaction with company offices with regard to internal locations audits scheduling and preparation
• Liaising with project teams with regard to maintenance of external systems/study audits tracking log
• Liaising with CAPA Investigation teams with regard to corrective/preventive actions implementation, tracking, and follow up
• Interaction with country Heads with regard to development/update of country level organizational charts
• Interaction with PSI Systems Development personnel with regard to maintenance and management of the Release of PSI QSDs to external parties PRIMA application
• Administrative support to PSI Quality Management (QM) staff
• Assistance to PSI QA auditors with quality assurance study audits scheduling and preparation
• Assistance to PSI QA auditors with vendor qualification audits scheduling and preparation
• Assistance to PSI QA auditors with internal systems and location audits scheduling and preparation
• Assistance to external Audit Host with the client/third party audits of PSI scheduling, planning, and hosting
• Maintenance of PSI internal and external audits tracking log, contracted audits tracking log, vendor qualification audits tracking log and of the CAPA tracking log
• Maintenance of PSI Quality File
• Maintenance of the PSI organizational charts, including on the Group and country levels
• Assembling of internal systems/locations/study audits documentation
• Assembling of contracted audits documentation, vendor qualification audits documentation, and external audits of PSI documentation
• Maintenance of PSI QSDs Intranet
• Development and processing of Quality Management Records documenting QSD lifecycle
• Assistance to project teams, divisions, and offices with regard to the management of client/third party requests for QSD release through the PRIMA application
• Management of the Quality Management Records related to release of PSI QSDs to external parties