Quality Assurance Assistant

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

• 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 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, vendor qualification audits, and 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 audits tracking log, contracted audits tracking log, vendor qualification audits tracking log, external audits tracking log, and CAPA tracking log
• Maintenance of PSI Quality File and PSI organizational charts, including on the Group and country levels
• Assembling of internal systems/locations/study audits documentation, contracted audits documentation, vendor qualification audits documentation, and external audits of PSI documentation
• 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

Qualifications

• College or university degree
• Minimum 2 years' professional experience in a quality-oriented role
• Clinical research industry experience is a plus
• Advanced proficiency in MS Office (Word, Excel, Power Point, Outlook)
• Strong oral and written communication skills
• Ability to handle basic office equipment
• Strong formatting and proofreading skills

Additional Information

All your information will be kept confidential according to EEO guidelines.