Quality Assurance Systems Consultant I

4 weeks ago


CAMBRIDGE MA, United States Planet Pharma Full time

Responsibilities:
The Quality Systems Contractor will work to support the implementation of process improvements and workflow optimizations within Document Control and Quality Systems.   

  
Summary of Key Responsibilities:
?     Support updates to Veeva meta-data, including review of existing configuration and making necessary changes required for system integrations.

?     Provide document processing support, including review of controlled GxP documentation for compliance with GDocP standards and internal processes.

?     Provide customer support with Veeva Quality Systems issues.

?     Support other process improvement initiatives as required.

?     Manage Global Quality Systems SOP revisions.

  
Requirements
?     Bachelor’s Degree (BA/BS) and 3-4 years’ experience in an FDA regulated environment or similar experience preferred.

?     Prior system administration experience required, with administration of Veeva Quality Suite preferred.

?     Strong understanding of GxP Regulatory Requirements around Document Control and Training.

?     Understanding of GxP Regulatory Requirements around Quality Management Systems.

?     Self-directed and ability to independently complete projects with an eye for detail.

?     Strong interpersonal and organization skills

?     Excellent computer skills including MS Word, Excel and Powerpoint. 

?     Project management skills 


Pay ranges between $35-40/hr based on experience 



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