Compliance Specialist QC

Job description

Within this role you will support QC compliance by managing deviations, investigations, change controls, and CAPAs. Coordinate cross-functional activities, track and report quality system metrics, and drive continuous improvement to meet cGMP and regulatory expectations. As an Compliance Specialist QC, a typical day might include the following: - Authoring and peer-reviewing QC laboratory investigations and deviations, including NOE, EOE, DNF, and GLIF investigations - Leading and documenting corrective and preventive actions (CAPAs) and change controls - Coordinating cross-functional teams during change control/CAPA events and deviations and align on action plans - Reviewing, editing, and revising controlled documents (e.g., SOPs, logbooks) to ensure cGMP compliance - Creating and maintaining QC quality records and workflows; ensure timely, accurate documentation - Tracking and maintaining status of open QC compliance records (deviations, CAPAs, change controls, workflows) - Compiling and reporting quality system metrics to QC leadership and stakeholders - Conducting cross-functional laboratory investigations across QC; coordinate resources from multiple departments - Representing...