EVELYN M. GUEVARA

• Reviews, in a timely manner, all batch and test documentation associated with investigational medicinal products (IMPs), APIs, raw materials and packaging components and releases those found in compliance into SAP and Quality management system as applicable
• Responsibilities include the scheduling and planning of work against timelines
• Supports in the investigation of non-conformances and quality incidents
• Conducts appropriate follow-up, as required Tracks and trends deviation investigations and CAPAs
• Rejects APIs, raw materials, packaging components, and bulk products, filled and packaged IMPs that fail compliance to GMP regulations and BMS specifications and requirements
• Ensures records relating to the manufacturing, packaging,testing of IMPs are submitted to the documentation center to be maintained in compliance with the record retention schedule as required
• Reviews and approves documents related to Quality Systems such as master batch records, validation protocols/reports, change control, or SOP/WI/OIs to support the release function
• May conduct GMP Training for functional areas supported and provides on-the-job training to new Quality Operations employees, as requested
• Supports management in monitoring document tracking and manpower resource allocations
• Coordinates scheduling/review of records as requested
• Participates in the monitoring program for product quality checks, media fills and visual inspection program as applicable
• Support internal and/or external audits as required

• Serves as the Quality single point of contact for the assigned CMOs with responsibility for Quality and Compliance performance
• Reviews all batch and test documentation associated with investigational medicinal products (IMPs) and perform batch releases
• Reviews and approves all CMO investigations and change controls
• Lead Product Quality Complaints, Deviations, and CAPAs
• Oversees CMO change control process and ensures that BMS products are manufactured in full compliance with all applicable regulations
• Works with Technical Operations to identify Quality and Compliance risks and develop/implement plans to mitigate via a risk management approach
• Developed Quality metrics via Excel and created graphs to assess ongoing monthly performance
• Quality approvers for all GMP documentation associated with Batch Records, Investigation Protocols
• Final Batch Disposition decisions

• Ensures the safe disposition release of Clinical & Commercial products in accordance with company requirements as primary review for Liso-cel/Ide-cel
• Certified Trainer for both Liso-cel/Ide-cel products
• Keep track of all lots and assigned them to all primary/second reviewers
• In managements absence, step in for leadership meetings, lot release, and daily manager meetings
• Act as QA Disposition SME to delegate lot release status for Tier 2 Meetings
• Assist in Kaizen Project for EBR from 40 Abecma and 15 Liso-cel Patient Ramp-up
• Completed Six Sigma White belt certified
• Elected Quality Assurance Representative for BMS People Council.

• Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements
• Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
• Author and review relevant SOPs, validation, and other documents
• Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports
• Responsible for the completion of all client requirements related to cellular product and/or material releases
• Master Batch Record Control, distribution, and label verification
• Perform line clearance activities as required
• Assignment and maintenance of product Lot numbers as applicable
• Perform internal documentation audits as assigned
• Materials management nonconformance disposition and release activity as applicable
• Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures
• Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions
• Track and trend relevant quality metrics including environmental monitoring data
• Provide Quality Assurance related support to various departments
• Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies

• Maintaining list of SOPs due for review as well as tracking the review process, signatures, issuance appropriate department books, memos to staff of changes, as well as issuing new numbers for new SOPs
• Creating Good Laboratory Practice (GLP) folders and reviewing protocols pertaining to project and sending copies to be signed by client/sponsor
• Updating and maintaining GLP Master Schedule, archiving GLP folders as well as conducting GLP audits
• Reviewing daily GLP Microbiology reports for GMP compliance
• Preparation of letters to sponsors/clients about revisions to reports or raw data sheets,
• Being responsible for topics pertaining to ISO 17025
• Maintaining SOPs for review
• Audit and maintenance of GLP studies
• Responsible for ISO 17025 matters
• Maintenance of GBL audit book
• Addressing Quality Events and OOS

• Microbiological testing of products, sterility testing, water testing, bioburden testing, maintenance of laboratory cultures and microbial identifications
• Provided training for aseptic clean rooms during manufacturing of sterile products
• Reported Data in GIS and Excel spreadsheets
• Perform Sterility testing by USP method and AAMI Method
• Proficient in membrane filtration, Steritest, bioburden, biological indicator test and direct emersion
• Experienced working in sterility room under class 100 hood