Compile and report site Deviation and CAPA metrics to monitor overall QMS health and compliance, including Record Timeliness, Effectiveness Check Rates, Re-Open and Right First Time, Deviation Turn Around Times, and urgent ad-hoc requests.Facilitate and manage the Investigation and CAPA Review Board for end-to-end endorsement of Root Causes, CAPAs, and Effectiveness Checks, ensuring robust investigations and CAPAs that address root causes.Redesigned the Review Board Forum to streamline the proposal and endorsement process for Quality Events, creating and maintaining a Master Spreadsheet to document and track all Review Board Meeting decisions and scheduling.Lead Weekly CAPA Meetings to collaborate with action owners, driving accountability for CAPA Implementation and collecting status updates to identify and address roadblocks.Deliver SME expertise and requested metrics during Internal/Corporate Audits and Health Authority inspections.Provide Deviation, CAPA, Effectiveness Check, and Complaint metrics for site Quality Council. Collaborate cross-functionally with QA Operations and Manufacturing Investigations teams to report in-depth insights for each metric and brainstorm actions to address metrics that do not meet targets.Assist in Quality Council Governance, facilitating meetings, documenting actions and minutes, and coordinating data from all functional areas.Support various Tier Meetings by providing data related to CAPA Timeliness, Overdue/Coming Due CAPAs, Deviation per Lot data, and Manufacturing Failure Rate metrics.Analyze data to identify process improvements, bottlenecks, and trends related to QMS health, proposing new processes to enhance performance and efficiencies.Mentor and support the onboarding of new team members.

Supported Clinical Batch Release initiatives for Contract Manufacturing Organizations (CMOs) to ensure compliance with internal processes and procedures.Communicated effectively with external suppliers to address documentation and compliance issues.Oversaw the release of manufactured products, including bulk, primary, and secondary packaging processes.Reviewed clinical packaging and labeling protocols, packaging specifications and instructions, executed batch records, and supporting documentation for in-process and finished products.Evaluated master batch records and change controls to support batch release

Identified and implemented improvements to current business and system processes; updated corresponding procedures.Reviewed and approved site Change Controls (Veeva QMS) for accuracy and conformance to established guidelines and procedures.Coordinated Change Control Review Board (CCRB) meetings to approve Change Control Proposals and Implementation. Captured meeting minutes and action items and maintained a Master Spreadsheet to document and track all CCRB Meeting decisions.Supported QMS Migration and Implementation activities, including migrating legacy paper-based change controls to eQMS.Conducted User Acceptance Testing (UAT) and PQ UAT testing, including providing business subject matter expertise in reviewing business requirements.Conducted site training as a Qualified Trainer on new QMS to ensure effective implementation and execution.Managed the migration of over 70 change controls into the new QMS, ensuring records were migrated accurately.

Supported QMS activities related to the enhancement release cycle, including Requirements Review, PQ Test Script Development, and User Acceptance Testing for Complaints, CAPAs, Deviations, and Change Management.Reported monthly metrics and KPI data to senior leadership, escalating critical events as necessary.Conducted Super User responsibilities for Change Management, CAPA, and Deviation systems, including reassignments, rerouting, and providing guidance and solutions for process inquiries.Collaborated with IT to support QMS maintenance, including Key Word List Updates, Defect Resolution, and System Access Requests.

Assisted Global Quality Systems in the following ways: - Training and Development: Transitioned Instruction Led Training to new interactive Computer Based Training. I also supported activities related to the restructuring of Curriculum design for systems role-based-training modules. - System Management: Assisted in activities related to System Enhancement and Upgrade Release Cycle (e.g. Requirements Review, User Acceptance Testing, creation of communication materials), etc. I also assisted in activities that streamlined department training documents and GMP documents in Veeva Vault in order to align them with overall system enhancements. In addition, I collaborated with system Business Process Owners to develop processes. - Metrics and Data Analytics: Collaborated cross-functionally to assist in Data Validation efforts for the quarterly Global Management Review. I also participated in Quality Analytics and Decision Support System Activities, including data analysis, User Acceptance Testing, etc. - Supported in Integration Activities - Assisted in Administrative Activities for Global Quality Systems

Supported Global Quality Systems with deployment of Job Descriptions GMP Roles. Worked on master spreadsheet that aided in the deployment of Job Descriptions to GMP Employee's Assisted Global Quality Systems, GMP Training with the following:- Learning Management System Audit and clean-up activities- Coordinated Instructor Led Training Sessions- Updated the department and affiliate websites - Created new instructional content for critical electronic systems that replaced current paper-based job-aides and reference documents

Assist in driving recruitment objectives by supporting key project initiatives to enhance Celgene’s ability to effectively and efficiently hire top talent. - Recruiting vendor management project - Identify gaps in reporting and update records to ensure accurate reporting - Research projects in diversity recruiting, branding, social media, employee referral program, etc. - General recruiting coordination support such as job postings, scheduling, etc. - Data Analysis