The candidate is responsible for hands on, day-to-day cGMP activities as trained and required per schedule.
They interact directly with site staff, who are performing the daily operational functions (e.g. manufacturing, QC, etc.), in support of their effort to produce quality products.
This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the PU, QC labs, and other support area.
Ensure timely review of batch record for materials as instructed (e.g. media, apheresis, etc.).
Interface closely with PU and QC to assist with batch record/QC data review, release, and compliance issue resolution.
Review and audit production batch records, and/or QC related documentation, to ensure adherence to the Client policies, SOPs, and cGMP requirements.
Participates in activities associated with event resolution and CAPAs.
Implements and ensures adherence of appropriate regulations and the Client's quality standards.
Additional activities may be assigned for training and completion as required.
Demonstrates and role models the Client's values and behavior.