Marion Amoah
Alexandria
Summary
GMP-trained laboratory professional with experience supporting quality assurance, batch record documentation, and compliance-driven operations in regulated environments. Skilled in reviewing controlled documentation, supporting deviation investigations (CAPA), and ensuring data integrity. Strong background in instrument calibration, audit readiness, and cross-functional QA support, with proven ability to train staff and maintain compliance in high-throughput laboratory settings.
Overview
4
4
years of professional experience
Work History
Lab Generalist
Antech Diagnostics
06.2025 - Current
- Perform high-throughput clinical chemistry, cytology, and serology testing while adhering to strict quality control standards
- Review QC data and investigate abnormal results, ensuring accuracy and reliability of reported results
- Perform instrument calibration, maintenance, and troubleshooting to maintain compliance and minimize downtime
- Maintain accurate LIMS documentation and data integrity, ensuring traceability and audit readiness
- Train and onboard new personnel on laboratory procedures, instrumentation, and quality practices
Associate Scientist II (Lab Lead – Quality & Compliance)
MilliporeSigma
Rockville, MD
04.2023 - 03.2025
- Led laboratory operations in a GMP-regulated environment, ensuring adherence to SOPs and quality standards
- Authored, reviewed, and edited batch production records, ensuring completeness, accuracy, and compliance prior to release
- Conducted documentation review (batch records, logs, controlled documents) to support QA release activities
- Performed internal audits (6S/Six Sigma) and supported inspection readiness for regulatory compliance
- Led deviation investigations, including root cause analysis and CAPA implementation
- Partnered with QA/QC to ensure data integrity and compliance across laboratory processes
- Oversaw equipment calibration and maintenance programs, ensuring systems met operational and regulatory requirements
- Managed inventory and procurement of GMP materials, maintaining traceability and compliance
- Trained and mentored staff on GMP documentation and compliance practices
- Reviewed data for accuracy, completeness, and release readiness
Toxicology Lab Intern
James Madison University
01.2022 - 05.2022
- Performed qPCR, ELISA, SDS-PAGE, and cell culture techniques
- Conducted toxicity studies and documented results in structured lab reports
Education
M.S. - Cell & Molecular Biology
B.S. - Biology
James Madison University
Skills
- Quality Assurance: GMP, Batch Record Review, CAPA, Deviations, Audits (6S), Data Integrity
- Laboratory: Chemistry, Cytology, Serology, ELISA, qPCR, Cell Culture
- Operations: Calibration, Troubleshooting, LIMS, Environmental Monitoring
- Technical: Python, SQL, SPSS
- Leadership: Training, Cross-functional Collaboration
Timeline
Lab Generalist
Antech Diagnostics
06.2025 - Current
Associate Scientist II (Lab Lead – Quality & Compliance)
MilliporeSigma
04.2023 - 03.2025
Toxicology Lab Intern
James Madison University
01.2022 - 05.2022
B.S. - Biology
James Madison University