Erin Bennecke
Spring Grove,IL
Summary
Results-driven management professional with proven ability to lead teams to success. Strong focus on team collaboration, operational efficiency, and achieving measurable outcomes. Adept in cGMPs, Quality Management Systems, inspection readiness and site compliance. Known for adaptability and consistently meeting changing organizational needs.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Manager, Incoming Quality Assurance, Cell Therapy
Bristol-Myer Squibb
08.2023 - 07.2025
- Established Incoming Quality and Raw Material Retention sample program for start up manufacturing facility.
- Managed the Quality release of raw materials and consumables
- Performed the review and approval of global material specifications and methods
- Performs review and approval of global material change controls and supplier defect deviations
- Supported Global Supplier Quality in Material and Vendor Qualifications
- Supported PPQ readiness prior to FDA approval of gene therapy product
- Quality Owner of 2 ERP system implementations through development of test criteria, User Acceptance Testing, and development of system use SOPs.
Supervisor, Quality Assurance and Compliance
Novartis Gene Therapies (formerly AveXis, Inc)
07.2022 - 07.2023
- Oversee daily tasks, schedules, and accomplishments of 4 direct reports
- Team Lead for Incoming Quality Assurance actions related to new market launches
- Lead SME for Incoming Quality Assurance process during inspections
- Supported APQR by providing measurable data as related to Incoming Quality Assurance
- Managed multiple tasks for Quality Assurance as related to decommissioning of facility due to site closure.
- Trained associated from different sites in Visual Inspection and Secondary Packaging Release
Quality Assurance Associate
Novartis Gene Therapies (formerly AveXis, Inc)
09.2019 - 07.2022
- Created and maintained approximately 100 Raw Material Specifications.
- Performed quality release of approximately raw materials for production use.
- Owner and approver of Supplier Corrective Action Reports (SCARs)
- Maintained raw material retention sample inventory and annual inspection
- Performed visual inspection and release of printed commodities for multiple commercial markets
- Supported site inspection team.
- Chairperson for Monthly Quality Management Review
Sr. Process Specialist
AveXis, Inc
11.2017 - 09.2019
- Provided manufacturing floor support by Compiling up to 15 deviation investigations at a time and performing root cause analysis to determine appropriate CAPAs.
- Worked with CAPA owners on Continuous improvement opportunities during site Commercial launch.
Quality Assurance Compliance Specialist III
Shire Pharmaceuticals
08.2016 - 11.2017
- Provided Quarterly metrics for Quality Management Review as well as production metrics for Senior leadership.
- Member of site inspection team.
- Completed batch record review as needed to support document control group while integrating to new quality management system.
Quality Documentation Coordinator
Astellas US
04.2016 - 08.2016
- Provided documentation review and authorship of SOPs in a clinical setting, being integrated to GMP formatting.
Manufacturing and Quality Assurance
Catalent Pharma Solutions
07.2007 - 04.2016
- Production Data Analyst
- Completed shop floor material reconciliation, scrap counts and production yields
- Participated in Annual inventory of hundreds of warehouse materials
- Project Manager
- Developed project scope, timelines and training program for completed project
- Performed evaluation of multiple vendors against industry best practices to implement process improvements
- Managed timelines, updated documents to support improved program and reported on key milestones to Senior Leadership
- Managed the deliverables and input of project team members and escalated delays to management
- Provided training on improved process across multiple shifts to implement new program
- Drove project to completion by the target completion date
- Quality Assurance Technical Writer
- Author of deviation reports and SOP/FORM updates
- Owner of document related CAPAs and Corrections
- Quality Assurance Technical Specialist
- Managed input and responses to Customer Complaints for multiple product lines
- Worked with Compliance Manager to update Supplier Audit schedule
- Participated in on-site supplier audits with lead auditor
- Participated in on-site inspections by Health Authorities and CMO Clients
- Quality Assurance Product Specialist
- Quality Interface lead for multiple customers concerning quality records (deviations and complaints), change controls and CAPAs
- Quality Approver for deviations, change controls, customer complaints and various reports/protocols
- Provided quality metrics to third party clients for on-site Quarterly Business Reviews
- Compiled customer quality metrics for Quality Management Review
Education
Bachelor of Arts - English Composition
Southern Illinois University-Carbondale
Carbondale, IL06-2007
Skills
- Background in Blow/Fill/Seal, Seal/Fill/Seal manufacturing & Gene Therapies
- Well versed in cGMPs, 21 CFR 210, 211 and 820, ISO 9001 and 13485, FDA, EU and JP regulations
- Facility Audit Support – Self Inspection, Supplier Audits and Agency Audit
- Quality liaison for third party clients at CMO facility
- Deviation/CAPA/ Change Control ownership and management
- Complaint and Supplier Corrective Action Report (SCAR) Management
- Quality Release of Incoming Raw Materials
- Supported Gene Therapy site start up and Commercial and market Launches
- Commercial Label and printed commodity issuance
- Supported site decommissioning for 2 site closures
- Time management
- Decision-making
- Verbal and written communication
- Documentation and reporting
- Relationship building
- Cross-functional teamwork
Certification
- CQA Certified Quality Auditor- 2017 (Will re-certify)
- ISO 13485 and 9001 Internal Audit Training, McHenry County College- November 2012
- Project Management Tricks of the Trade: RMC Project Management, Inc. July 2009
Timeline
Manager, Incoming Quality Assurance, Cell Therapy
Bristol-Myer Squibb
08.2023 - 07.2025
Supervisor, Quality Assurance and Compliance
Novartis Gene Therapies (formerly AveXis, Inc)
07.2022 - 07.2023
Quality Assurance Associate
Novartis Gene Therapies (formerly AveXis, Inc)
09.2019 - 07.2022
Sr. Process Specialist
AveXis, Inc
11.2017 - 09.2019
Quality Assurance Compliance Specialist III
Shire Pharmaceuticals
08.2016 - 11.2017
Quality Documentation Coordinator
Astellas US
04.2016 - 08.2016
Manufacturing and Quality Assurance
Catalent Pharma Solutions
07.2007 - 04.2016
Bachelor of Arts - English Composition
Southern Illinois University-Carbondale
Similar Profiles
DENISTOR CARDONA MERCADODENISTOR CARDONA MERCADO
Sr. Manager, Process Shift Leader, Inspection & Packaging at Bristol Myer Squibb Holdings Pharma Ltd.Sr. Manager, Process Shift Leader, Inspection & Packaging at Bristol Myer Squibb Holdings Pharma Ltd.
Shishir ThakurShishir Thakur
Consultant at Bristol-myer SquibbConsultant at Bristol-myer Squibb
Luis Lugo CrespoLuis Lugo Crespo
Manufacturing Tecnichian Parenteral at Bristol Myer Squibb BiotechnologyManufacturing Tecnichian Parenteral at Bristol Myer Squibb Biotechnology
Haley HimmelspachHaley Himmelspach
Project Manager/Quality Assurance Specialist at Bio Fab TechnologiesProject Manager/Quality Assurance Specialist at Bio Fab Technologies
Jordyn NeumanJordyn Neuman
Urgent Care Registered Nurse - Travel Contract at Community Healthcare AllianceUrgent Care Registered Nurse - Travel Contract at Community Healthcare Alliance