- Manage the laboratory change controls, events, and CAPAs, ensuring on time completion and timely extension requests. Part of CC committee assessing all site change control for QC and QA compliance impact (approved vendor list). Review and approval of CCs, events and CAPAs for completeness and compliance. Also review and approval of laboratory SOPs.
- Writing and issuing laboratory change controls and SOPs. Processing change control actions items (as owner or verifier). Overseeing the training completion for the QC support team, ensuring on time completion. Compiling and assessing the QC metrics, which are presented to above site management and site quality review board. Attend monthly QRB representing the QC laboratory.
- Overseeing the LTS team and assessing projects and timeline to ensure deadline are met for method verification/validation. Routinely attend multiple site project meetings for new product launches, scaleup activities, etc. Attend the site compendial monthly meetings to ensure compliance with compendia
- Overseeing the metrology project lead activities and assisting as needed with equipment assessments, SOP updating and qualification activities.
- Overseeing the lab supply ordering team, reference standard and controlled substances coordinating. Assist with any issues or questions that may arise for these activities.
- Perform walkarounds of QC lab for assessment of cleanliness and orderliness, compliance assessment