Quality Assurance Officers

Position Title: Global Supplier Quality, External QC - Quality Records

The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL).

Coordinate shipping and testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a CoA/CoT.

This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.

Ability to work in a fast paced environment, meet deadlines, and prioritize work from multiple projects

• Detail oriented with demonstrated application in problem solving
• Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition
• Experience with Clinical and/or Commercial products manufacture, supply and post-approval change management
• Experience with Quality Systems (change control, deviation and investigation)

Education and Experience: • Bachelor's degree required in relevant scientific discipline, prefer 3 years' experience in biotherapeutics/biomanufacturing QC/QA, or an equivalent combination of education and experience.

Initiation, facilitation, and tracking of quality records

• Provide regular communication and metrics for status of quality records
• Effectively communicate issues, risks and proposed solutions within the organization
• Provide communication, support, and guidance to CTLs within the QA vector and upstream material team
• Working closely with other GSQ QC members to submit and track sample material for testing at CTL
• Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)
• Enter data and retrieve information from Sharepoint and Smartsheet testing trackers

May be required to work in office environment.

• Sitting, standing and computer work is required.