-Support project's various documentation implementation (SOPs, Calibration Records, PMs, Batch Records)-Support authors in the writing process with language usage, doc control process, and ensure documents are clear and reader-friendly-Execute the local change process for documents-Ensure adherence to the project's Quality Strategy and Regulatory Compliance-Collaborate cross-functionally and maintain stakeholder relationships

-SOP Development and Revision-Deviation/Customer Complaint Investigation and Documentation-CAPA Creation and Management-Quality ReportingSystems Used: Microsoft Suite, Qualio

Lead quality investigations for minor deviations with a focus on performance improvement and risk reduction.Identify root and contributing causes and recommend corrective and preventative actionsCollaborate cross-funtionally with QA and MFG teams Contribute to metrics related to deviation investigation process and CAPA effectivenessSystems Used: TrackWise, Kneat, CMMS, LabWare

Member of the batch record review team responsible for review of executed batch records, executed support records, and master records in accordance with GDP and internal/external client standards.Manage specific projects to ensure records are reviewed, client comments are resolved, and communicate with other departments to ensure support records and test sampling plans are complete prior to disposition of product activities.Selected to participate in an operation excellence initiative as a quality assurance representative with the goal to reduce batch record review turnaround times and improve right-first-time KPIs.Collect and report departmental metrics on a weekly, monthly, quarterly, and ad-hoc project-based basis to senior leadership. Qualified trainer with experience training new hires on job responsibilities and creating job aides and hosting in-person and virtual training sessions as needed for changes and improvements.Systems used: Microsoft (SharePoint, Excel, Ppt) , ASCTrac, BlueMountain, ETQ, ComplianceWire

Hired as a contractor to eliminate backlog of terminated and aborted batch records. Worked cross-functionally with individuals from departments including manufacturing, analytical teams, and sample coordination teams to process overdue records and streamline processes. Following successful elimination of terminated record backlog, was quickly brought on as a full-time employee for the company.

Hands-on experience working in downstream processes in GMP environment. Part of the cap/inspect team responsible for utilizing machinery to cap vials of product in A/B space, utilize machinery to perform inspection of vials in C space, and perform manual quality inspection of sampled product in accordance with SOPs and GMP standards. Additionally performed ad-hoc responsibilities including: environmental air and surface monitoring/testing, material transfers, GDP documentation, and training.Systems used: SAP, PAS-X, GLIMS