Manufacturing Document Reviewer primary responsibility is the review of assigned manufacturing documentation and driving the subsequent corrections needed, prior to Quality review of each document. Documentation includes executed manufacturing batch records and ancillary documentation such as cell counts and equipment readouts, as well as logbooks, and GMP forms used in the production of Viral Vector (VV) Batches at the Lonza Houston Facility.
Additional duties include updating and maintaining the document review tracker for VV Manufacturing. Manufacturing Document Reviewer are responsible for escalations to senior members and Supervisors of the team for complex issues that arise during review.
A Manufacturing Document Reviewer demonstrates an understanding of Quality Systems, Manufacturing practices, Good Documentation Practices, as well as additional professional skills of effective communication and listening. Training of junior staff may be requested for certain tasks.