Overview :

Our bio-pharmaceutical client in the Northeast needs a QA Consultant to support their team for the next 6 months, and there is a strong likelihood of extension based on performance.

Our client needs to fill this role ASAP and we are targeting a start date in late March. Our client will be prioritizing candidates who can be on-site 3-5 days / week, although remote candidates will not be ruled out if they can travel onsite once per month.

This role will have a heavy emphasis on product disposition and process improvement.

• Responsibilities : Ensure on-time disposition of products are in compliance with cGMP and international requirements
• Perform product disposition activities and generate required documentation for product release, as well as provide support for all related product release activities.
• Provide quality expertise for process improvements
• Support internal and external Qualified Person (QP) confirmation and certification activities
• Support management of quality records such as change controls and deviations
• Assist with management of product trackers and maintain product disposition metrics
• Other duties as assigned to support QA projects and objectives
• Qualifications : BS Degree minimum with 8 years of biotechnology or pharmaceutical experience, Gene Therapy experience is preferred
• Strong background in product disposition with an understanding of international requirements
• Must be able to demonstrate understanding of how materials and products are verified prior to being released
• Experience in change controls and deviations
• Must demonstrate strong communication, organization, and interpersonal skills
• Experience with Smartsheet is preferred
10 hours ago