Job Code: 10136061
Mandatory / Primary Skills:
Quality & Regulatory Documentation Expert 1
This position is responsible for supporting client-facing projects as a member of the Life Cycle Management team within Technical Operations. The successful candidate will work cross-functionally with the Manufacturing, Process Development, and Quality teams to implement changes to bioprocesses in cGMP production.
Responsible for activities including:
Collaborate cross-functionally with both internal and external stakeholders to implement changes which enable continuous improvement, scale-up, and sustaining of existing cGMP manufacturing processes.
Coordinate and drive change orders and related efforts to update manufacturing documentation including batch records, item specifications, forms, SOPs, and bills of material for existing processes.
Assist with internal projects to develop and optimize process and product Life Cycle Management and ensure robustness, repeatability, and scalability of cGMP operations.
Support the execution of process risk assessments, qualification protocols and reports, and other operational activities that increase safety, reduce operation costs, and maintain cGMP compliance.
Interact with multi-disciplinary groups and ensure effective communication.
Work both independently and collaboratively as part of a team.
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