MICHELLE OSIEMI
Silver Spring,MD
Summary
Results-oriented Quality Assurance Specialist with over 10 years of experience in supporting and managing internal audits, supplier evaluations, and quality system enhancements within regulated pharmaceutical environments. Proven expertise in championing process audits, enforcing compliance, and leading CAPA investigations to ensure adherence to stringent regulatory standards. CQA-certified with a strong ability to develop effective training tools, analyze quality metrics, and drive cross-functional improvements that enhance operational integrity and efficiency. Committed to fostering a culture of continuous improvement and excellence in quality assurance practices.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist II
UNITED STATES PHARMACOPEIA
Rockville, MD, US
01.2018 - Current
- Manage and implements the Internal Audit Program including facility inspections, method audits, target audits, and process audits.
- Manages and implements the Supplier Evaluation Program including performing external on-site audits
- Manages Laboratory Project Review Program, ensuring alignment with SOPs, ISO 9001 and ISO 17025 standards.
- Oversee quality documentation and event tracking using MasterControl, supporting effective CAPA management, audit readiness, and alignment with regulatory and procedural expectations across internal and supplier operations.
- Develop and deliver comprehensive trend analysis reports on customer complaints and inquiries, providing insights that influence leadership decisions, identify recurring quality issues, and support continuous improvement initiatives.
- Lead and mentor a cross-functional team responsible for executing audits, conducting laboratory documentation reviews, and ensuring alignment with regulatory consistency, accuracy, and operational expectations.
- Design and develop training materials and instructional materials pertaining to Quality concepts and tools and provide training.
Quality Assurance Specialist I
UNITED STATES PHARMACOPEIA
Rockville, MD, US
07.2015 - 01.2018
- Supported quality investigations and scientific project reviews by compiling documentation and facilitating communication among teams to meet tight project deadlines and regulatory requirements.
- Validated batch and label records to ensure compliance and accuracy, authorizing release of compliant product inventory with minimal errors and delays, supporting timely product distribution.
- Conducted facility, process, and method audits, tracking findings and resolutions through MetricStream to maintain regulatory standards while supporting audit preparedness efforts and continuous quality improvement.
- Isolated nonconforming materials and coordinated resolution efforts, safeguarding inventory integrity per SOPs and regulatory compliance requirements, reducing risk of product recalls or compliance violations.
Re-labeling Quality Assurance Associate
UNITED STATES PHARMACOPEIA
Rockville, MD, US
09.2014 - 07.2015
- Entered and verified quality-related data in internal tracking systems, maintaining documentation accuracy for re-label operations and supporting traceability, audit readiness, and compliance.
- Inspected batch documentation for re-labeling accuracy and authorized inventory release, ensuring product integrity and compliance with FDA regulations, internal SOPs, and company quality policies.
- Coordinated with distribution teams to confirm batch readiness for shipment, ensuring timely product availability and supporting smooth supply chain processes across multiple distribution centers.
- Segregated defective materials and escalated nonconformance issues to management, contributing to risk mitigation efforts and minimizing disruptions while upholding quality standards and regulatory expectations.
Education
Bachelors of Science - Biochemistry
Canisius College
05.2014
High School Diploma - undefined
Georgetown Visitation Preparatory School
06.2009
Skills
- Audit Planning & Tracking
- Supplier Evaluation
- RCA/CAPA Investigation/Deviation Management
- Quality Management Systems (QMS)
- ISO 9001, ISO 17025, ISO 17020, ISO 17065 implementation
- Process Improvement Initiatives
- Training Development & Delivery
- Laboratory Documentation Review
- Data Integrity Assurance
- Quality Metric Reporting
- Cross-Functional Team Leadership
- MasterControl Document Management
- Problem-solving skills
- Analytical thinking
- Detail-oriented
Certification
Certified Quality Auditor (CQA)
Timeline
Quality Assurance Specialist II
UNITED STATES PHARMACOPEIA
01.2018 - Current
Quality Assurance Specialist I
UNITED STATES PHARMACOPEIA
07.2015 - 01.2018
Re-labeling Quality Assurance Associate
UNITED STATES PHARMACOPEIA
09.2014 - 07.2015
High School Diploma - undefined
Georgetown Visitation Preparatory School
Bachelors of Science - Biochemistry
Canisius College