Angela Zimmerman
Montgomery Village,MD
Summary
Highly motivated quality professional with extensive experience in Quality roles in GMP manufacturing. Outstanding communication and team collaboration skills with a proven track record in fast paced environments. Deep knowledge of GMP manufacturing in sterile environments. Excels at building trusting relationships with customers and colleagues with the ability to thrive in a matrix environment. Lead auditor for over 35 GMP/ISO audits.
Overview
14
14
years of professional experience
Work History
Senior Stability Specialist/Manager
Novavax
Germantown, MD
11.2020 - Current
- Oversaw external stability program with multiple contract manufacturers and outside testing laboratories. 95% on time completion of testing.
- Responded as subject matter expert for all quality records such as change controls, deviations and out of specifications.
- Authored regulatory sections for EUA and then associated BLA.
Senior Supplier Quality Engineer
DSM Biomedical
Exton, PA
04.2019 - 11.2020
- Identified materials needed for product assembly for all manufactured goods as defined in product specifications.
- Facilitated root cause analysis and corrective actions of supplier quality issues with a 95% on time completion rate.
- Scheduled and conducted audits to identify areas of risk in supplier's production, engineering, quality, supply chain, and overall GMP and ISO processes. Adherence to schedule was 100%.
Stability Manager
Sanofi Pasteur
Swiftwater, PA
07.2016 - 04.2019
- Executed and managed the stability program by maintaining compliance with internal procedures, industry regulations, and regulatory guidance requirements.
- Assigned stability testing work, managed stability inventory, performed trend analysis of the stability data, maintained schedule of stability pulls, testing deadlines, and reporting deadlines.
- Authored, reviewed and approved stability protocols, summaries and reports as well as relevant stability sections of regulatory submissions.
Quality Supplier Manager
AstraZeneca Supply Biologic
Gaithersburg, MD
12.2012 - 06.2016
- Excelled in relationship management for the collaboration of external manufacturers and testing labs to ensure and maintain high quality standards throughout the process.
- Implemented batch record review/ release processes resulted in 95% of batches being released on time. Supervised and coordinated change management for changes implemented by CMOs with 100% regulatory compliance.
- Implemented a supplier scorecard system to track performance metrics and drive continuous improvement efforts.
- QA lead for implementation of new fill/finish line at CMO. No interruption for available marketed product.
Quality Control Planner
MedImmune
Frederick, MD
01.2012 - 12.2012
- Recommended opportunities for improvement of company's QC plan after comprehensive review of strengths & weaknesses.
- Ensured proper resource allocation for QC department by interpretation of metrics and data.
- Reduced the time taken to disseminate pertinent information with effective communication practices with both senior and junior management staff.
Education
Bachelor of Science - Business Administration
Hood College
Frederick, MDMedical Laboratory Technology
Penn State University
Hazelton, PASkills
- Certified quality auditor
- Quality records management lead
- Effective in high-pressure settings
- QA Oversight of CMO and Testing Labs; Relationship Management
- Leadership in quality assurance for new manufacturing line
- Process Mapping, Root Cause Analysis, Statistical Analysis
- LIMS, Document Systems, Veeva, TrackWise, Gazelle
- Project Management
- Supplier Relationship Management
- Teamwork and Collaboration
- Problem-solving, Time management, Attention to Detail
- Working Remotely- Microsoft Teams
Timeline
Senior Stability Specialist/Manager
Novavax
11.2020 - Current
Senior Supplier Quality Engineer
DSM Biomedical
04.2019 - 11.2020
Stability Manager
Sanofi Pasteur
07.2016 - 04.2019
Quality Supplier Manager
AstraZeneca Supply Biologic
12.2012 - 06.2016
Quality Control Planner
MedImmune
01.2012 - 12.2012
Medical Laboratory Technology
Penn State University
Bachelor of Science - Business Administration
Hood College