Deborah M. Harris
Rocky Mount,NC
Summary
Hands-on pharmaceutical operations and quality professional with deep experience in batch record auditing, records retention, and SOP-driven documentation control. Known for verifying calculations, maintaining secure filing systems, and coordinating record transfers across facilities while supporting trained, compliant handling of quality documents.
Overview
32
32
years of professional experience
Work History
Batch Record Release Specialist
Pfizer Inc.
Rocky Mount, NC
07.2009 - 07.2025
- Audited batch records for compliance with SOPs, GMP requirements, and company standards, ensuring adherence to quality standards.
- Independently evaluated and resolved quality documentation issues.
- Reviewed and prioritized daily production lists to facilitate timely product release and streamline operations.
- Organized and maintained batch records in accordance with company requirements, supporting efficient documentation retrieval.
- Coordinate secure transfer of completed documentation between facilities for final release.
Batch Record Specialist II
Hospira Inc.
Rocky Mount, NC
04.2005 - 11.2009
- Audited manufacturing documentation, sterilization packages, subassemblies, and production records for accuracy and compliance.
- Verified calculations and documentation prior to approval and release.
- Maintained quality records and filing systems for manufacturing quality assurance documentation.
- Retrieved, tracked, and archived batch records and related documentation.
- Trained new employees within the department.
- Assisted employees, supervisors, and managers with document retrieval and quality documentation requests.
- Supported records retention and document storage activities for multiple manufacturing facilities.
Labeling Operator
Abbott Laboratories
Rocky Mount, NC
09.1993 - 04.2005
- Operated and monitored labeling and packaging equipment according to standard operating procedures.
- Performed quality checks to ensure product labeling accuracy.
- Monitored equipment performance and assisted with routine production activities.
- Maintained production records and adhered to GMP requirements.
Education
Business Administration coursework -
Winston-Salem State University
High School Diploma -
Northern Nash Senior High School
Skills
- Batch Record Review & Release
- GMP Compliance
- Quality Assurance Documentation
- Document Control & Records Management
- SOP Compliance
- Audit Readiness & Support
- Data Verification & Accuracy Review
- Cross-Functional Team Collaboration
- Microsoft Office 365,
- Excel
Timeline
Batch Record Release Specialist
Pfizer Inc.
07.2009 - 07.2025
Batch Record Specialist II
Hospira Inc.
04.2005 - 11.2009
Labeling Operator
Abbott Laboratories
09.1993 - 04.2005
Business Administration coursework -
Winston-Salem State University
High School Diploma -
Northern Nash Senior High School