Zoe Bevelle
Raleigh
Summary
Quality Assurance professional with strong background in ensuring product integrity and compliance. Skilled in identifying system inefficiencies, implementing effective quality control measures, and enhancing operational processes. Known for fostering team collaboration and adapting to evolving project demands while consistently achieving high-quality results. Equipped with analytical skills, attention to detail, and commitment to continuous improvement.
Overview
6
6
years of professional experience
Work History
Expert Associate-QA Floor Support
Eli Lilly Pharmaceuticals
07.2024 - Current
- Troubleshoot and provide QA systems support to reconcile issues in multiple systems (i.e., SAP, EWM, Darwin and other systems as required)
- Lead, mentor, and coach 60 Operations, and support personnel on quality matters, while driving the site Quality culture.
- Assist in root cause analysis investigations for deviations using TrackWise.
- Participate in self-led inspections and provide support during internal / external regulatory inspections.
- Review and approve GMP documentation in support of operations such as: Electronic Logs, SOPs, Sampling plans and other documents in VeevaVault, and PMX.
- Enhance customer satisfaction by conducting inspections on retain samples in support of customer complaint investigations.
- Serve as a subject matter expert within the QA team, providing guidance to junior team members.
- Responsible for adhering to safety rules and maintaining a safe work environment by supporting HSE corporate and site goals.
Manufacturing Quality Assurance Specialist
Actalent (Contracted at Pfizer)
02.2024 - 07.2024
- Identified quality events, investigated and determined root cause, escalated findings to senior management and assisted with CAPA process as applicable.
- Spearheaded documentation management through weekly reconciliation of control printed forms.
- Parallel reviewed and approved GMP documentation including Master Batch Records, Job-Aids and SOPs.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Optimized workflow efficiency by introducing automation tools into the QA process where appropriate.
Lead Manufacturing Document Associate II
Regeneron
11.2021 - 02.2024
- Reviewed Master Batch Records, Protocols and Logbooks for accuracy and data integrity.
- Monitored and coordinated utilization of controlled documents from issuance through archival.
- Created, ordered and scheduled lots for Cell Banking, Upstream, Mid-stream and Down-stream processing functions.
- Created LIMS Login Templates for specific molecules.
- Analyzed and created redlines on 100+ technical documents such as SPECS, Sampling Plans, SOPs and Work Instructions.
- Owned tasks for various change controls and monitored progress from initiation through execution.
- Ensured accurate system inventory was maintained through performance of inventory reconciliations and facilitation of material delivery review.
- Supported deviation review, investigations, CAPA initiation and CAPA closure by providing various metrics.
- Resolved on the floor manufacturing issues, such as consumption restraints for MES relevant and Non-MES relevant lots.
- Identified opportunities for improvement including CIs and JDIs.
- Managed 3 Associates and 2 Contractors.
Compliance Coordinator
Alaant (Contracted at Regeneron)
01.2021 - 11.2021
- Served as liaison to 6 stakeholders regarding change control initiation and approval.
- Reviewed 200+ Partner Notification Forms for compliance with (GDP) and routed them across departments for final signatures and authorization.
- Stayed current on emerging regulatory changes, ensuring timely updates to internal policies and procedures.
- Streamlined processes for increased efficiency in monitoring and reporting compliance activities.
- Facilitated and recorded minutes for meetings with domestic and international partners on weekly basis.
Partnership Specialist
United States Census Bureau
06.2019 - 09.2020
- Established and maintained partnership agreements to develop strategies to support the Decennial Census.
- Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Developed presentations, briefings and conducted meetings weekly with 70+ partners and stakeholders to discuss program milestones
- Hosted trainings, seminars and events with community leaders and general public in support of program goals.
Education
Bachelor of Arts - Health Administration
University At Buffalo
Amherst, NYSkills
- Regulatory compliance
- Quality assurance
- Document management
- Process improvement
- SAP
- Organization and time management
- VeevaVault
- TrackWise
- PMX
- Darwin
- GMARS
- Excellent communication
Timeline
Expert Associate-QA Floor Support
Eli Lilly Pharmaceuticals
07.2024 - Current
Manufacturing Quality Assurance Specialist
Actalent (Contracted at Pfizer)
02.2024 - 07.2024
Lead Manufacturing Document Associate II
Regeneron
11.2021 - 02.2024
Compliance Coordinator
Alaant (Contracted at Regeneron)
01.2021 - 11.2021
Partnership Specialist
United States Census Bureau
06.2019 - 09.2020
Bachelor of Arts - Health Administration
University At Buffalo
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