Project Manager/Senior Quality Engineer
Deborah has diversified experience in the pharmaceutical, medical diagnostics and device manufacturing industry. Background blends a strong technical orientation with results-oriented business skills in manufacturing operations, quality assurance and regulatory compliance. Strong focus on quality and efficiency with proven track record in product development, process improvement, GMP compliance, validation, and quality control.
- Served as lead consultant, Design Change team, for major medical device diagnostics manufacturer under Consent Decree. Led cross-functional team through gap analysis of change control process and procedures to identify design change, design validation and design verification requirements. Identified procedural errors and gaps. Developed new processes, procedures, and training compliant with all applicable CFRs for Design Control and Change Control. Oversaw implementation and integration of new processes, procedures, and training at site as well as division.
- Project Manager for CAPA files assessment team for a leading Class III implantable stent device manufacturer in preparation for FDA inspection. Led team charged with identifying compliance gaps and identifying remediation recommendations.
- Provided direction and support to Operations, Technical, Quality Assurance/Control and Regulatory Departments in various pharmaceutical companies in the review and optimization of organizations and systems, development of policies and procedures such as Validation, Change Control, Annual Product Review, Failure Investigations, Batch Record Review, Stability, Complaint Review and Analysis among others.
- Evaluated and created Standard Operating Procedures (SOPs), Master Batch Records, Master Packaging and Labeling Records and Validation Reports for the pharmaceutical and medical device industry
- Reviewed and prepared product approval submissions, such as 510Ks, NDAs, IDEs and PMAs
- Maintain and improve the quality of specialized control products through continuing process improvements. Train department personnel and other closely related employees on new techniques in the industry and on pertinent standard operating procedures and technology and software.
- Led process improvement team that halved production times and tripled yields for recombinant human TF.
- Extensive research, development and production scale up experience for clinical diagnostic products.
- Project Manager/Senior Quality Engineer – BioTeknica, Inc.
- Regulatory Associate – AccuReg, Inc.
- Regulatory Affairs Specialist – Dade-Behring
- Technical Quality Operations Scientist – Dade-Behring
- Senior Research Scientist – Baxter Diagnostics
- Manager of Research and Development – Baxter Diagnostics
- M.S., Biomedical Industrial Sciences – Barry University
- B.A., Chemistry – St. Thomas