Maggie Oberly
Raleigh
Summary
Biopharmaceutical professional with 9 years of experience in cGMP biotech operations across Quality Assurance, Quality Control, and Analytical Development. Proven track record of leading cross-functional initiatives, driving operational excellence, and delivering risk-based solutions that support compliance, quality, and business objectives.
Overview
10
10
years of professional experience
Work History
QA Specialist
FUJIFILM Diosynth Biotechnologies
Holly Springs, NC
08.2024 - Current
- Quality Events: Review and approve 15–25 deviations, CAPAs, and change controls monthly across five laboratory functional areas, ensuring timely resolution, GMP compliance, and uninterrupted laboratory operations.
- Validation & Qualification: Reviewed and approved vendor qualification and validation documentation in Kneat to ensure compliant equipment qualification, support inspection readiness, and maintain project timelines for lab readiness.
- Quality Risk Management: Cross functional collaboration with QC, Manufacturing, Validation, Engineering, and Process Development to evaluate product impact, identify root cause, and implement risk-based solutions.
- Continues Improvement: Developed quality dashboards that track quality records status, streamline workload prioritization, and support on-time completion of quality records.
Scientist I
FUJIFILM Diosynth Biotechnologies
Morrisville, NC
01.2022 - 04.2024
- Method Validation/Tech Transfer: Supported analytical method validation, stability, and technology transfer activities for biologics programs in a cGMP environment.
- Deviation Investigations: Initiated and resolved laboratory investigations while supporting timely corrective actions.
- Cross-Functional Collaboration: Partnered with QA, QC, and Process Development to deliver testing and documentation on schedule.
- Data Integrity: Reviewed analytical data and documentation to support compliant product release.
Associate Scientist
FUJIFILM Diosynth Biotechnologies
Morrisville, NC
10.2020 - 01.2022
- Method Validation: Performed ELISA, qPCR, and potency assays supporting validation and method transfer activities.
- Validation Documentation: Prepared and reviewed GMP documentation for validation studies.
- GMP Compliance: Supported multiple validation projects while maintaining SOP and regulatory compliance.
Analyst II
BioAgilytix
Durham, NC
01.2019 - 08.2020
- FDA Compliance: Performed bioanalytical testing supporting regulated clinical studies under FDA/GCP requirements. Maintained study documentation and ensured inspection readiness.
- Inspection Readiness: Maintained compliant study documentation and supported sponsor audits.
- Project Execution: Coordinated testing activities to consistently meet sponsor timelines.
Medical Laboratory Technician
North Carolina State University College
Raleigh, NC
10.2018 - 01.2019
- Routine Testing: Performed ELISA, qPCR, microbiology, and clinical diagnostic testing.
- Quality Documentation: Maintained QC documentation and supported compliant sample processing.
Technologist
LabCorp
Durham & Burlington, NC
09.2016 - 10.2018
- Routine Testing: Performed analytical testing for high-volume clinical drug screening.
- Quality Documentation: Maintained instrument documentation and electronic records in compliance with GCP standards.
Education
Master of Business Administration -
East Carolina University
Greenville, North Carolina01-2027
Bachelor of Science - Psychology
North Carolina Central University
Durham, NC10-2018
Bachelor of Science - Biology
North Carolina Central University
Durham, NC12-2015
Skills
- Vendor Qualification Oversight
- Quality Management Systems (QMS)
- Risked-Based Quality Decisions
- Deviation Investigations & CAPA Management
- Regulatory Compliance (GMP, GCP, GLP)
- Audit & Inspection Readiness
- Validation Documentation Review
- Equipment Qualification (IQ/OQ/PQ)
- Change Control Management Review
- Cross-Functional Collaboration
- SOP Development & Management
- Continuous Improvement
Technical Skills
Equipment/Instrument Qualification, Method Validation, Technical Documentation Review, Quality Management Systems, Laboratory Systems,
Systems: Trackwise, Veeva, Kneat, SAP, LIMS, Smartsheet, Tableau, Microsoft Suite
Timeline
QA Specialist
FUJIFILM Diosynth Biotechnologies
08.2024 - Current
Scientist I
FUJIFILM Diosynth Biotechnologies
01.2022 - 04.2024
Associate Scientist
FUJIFILM Diosynth Biotechnologies
10.2020 - 01.2022
Analyst II
BioAgilytix
01.2019 - 08.2020
Medical Laboratory Technician
North Carolina State University College
10.2018 - 01.2019
Technologist
LabCorp
09.2016 - 10.2018
Bachelor of Science - Biology
North Carolina Central University
Bachelor of Science - Psychology
North Carolina Central University
Master of Business Administration -
East Carolina University