Jessica Turgeon
Dracut,MA
Summary
Master’s student in Pharmaceutical Sciences with a B.S. in Applied Biomedical Sciences – Clinical Science and over three years of experience in FDA-regulated clinical operations at BioLife Plasma Services (Takeda Pharmaceuticals). Skilled in biospecimen management, phlebotomy, GCP/GMP compliance, and EMR-adjacent data systems. Proven ability to ensure protocol adherence, data accuracy, and regulatory readiness—driven to apply scientific and operational expertise to clinical research and patient-focused studies.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Center Supervisor
BioLife Plasma Services (Takeda Pharmaceuticals)
02.2023 - Current
- Lead daily clinical operations for an FDA-regulated plasma collection center, ensuring adherence to federal, state, and company-specific quality, safety, and donor-care standards.
- Supervise and train multidisciplinary teams on Good Manufacturing Practices (GMP), SOP compliance, and quality control protocols aligned with Takeda’s global quality systems.
- Monitor donor health screening, phlebotomy, and sample-processing procedures to ensure data accuracy and regulatory compliance in support of biologic product development.
- Collaborate cross-functionally with management, quality assurance, and medical staff to resolve non-conformances and implement CAPA (Corrective and Preventive Actions).
- Oversee documentation of donor eligibility, product traceability, and adverse event reporting within electronic systems to maintain audit readiness.
- Drive continuous improvement projects focused on workflow efficiency, donor conversion, and reduced wait times—achieving measurable gains in throughput and satisfaction metrics.
- Mentor and evaluate staff performance through coaching, feedback, and competency assessments to maintain operational excellence and compliance consistency.
- Participate in internal audits and safety reviews, ensuring compliance with FDA, EMA, and cGMP standards relevant to biologic sample collection and storage.
Senior Sample Processing Technician
BioLife Plasma Services (Takeda Pharmaceuticals)
08.2022 - 02.2023
- Executed all aspects of sample processing for human-derived plasma units in a regulated cGMP environment, ensuring traceability, temperature control, and documentation accuracy for downstream biologic testing.
- Verified labeling, storage, and shipment of clinical plasma samples according to FDA, EMA, and internal Takeda quality standards.
- Monitored freezer and refrigerator logs, maintained controlled-temperature storage (−20 °C to −40 °C), and prepared quality shipments for laboratory analysis.
- Performed venipuncture and donor eligibility assessments; collected and processed biological samples for screening and testing in compliance with SOPs and GCP-aligned documentation standards.
- Recorded donor vitals and lab results (hematocrit, protein, etc.) within electronic Donor Information System (DIS), ensuring data integrity for clinical and regulatory review.
- Supported deviation management and CAPA documentation by reporting non-conformances and assisting with root-cause investigation and process improvement.
- Maintained aseptic technique and biosafety practices while working with blood-borne pathogens (BSL-1 level).
- Partnered with quality and medical personnel to ensure safety compliance and readiness for regulatory inspections and internal audits.
Sample Processing Technician
BioLife Plasma Services (Takeda Pharmaceuticals)
06.2022 - 08.2022
- Processed, labeled, and prepared plasma samples for storage, testing, and shipment in compliance with FDA and cGMP regulations.
- Maintained chain of custody and temperature integrity of biospecimens through detailed freezer monitoring and documentation.
- Followed SOPs for plasma unit preparation, labeling accuracy, and traceability across all processing steps.
- Collaborated with quality and medical staff to ensure donor eligibility and accurate sample data entry in the Donor Information System (DIS).
- Monitored equipment performance and assisted in preventive maintenance to support continuous operation in a regulated biological environment.
- Applied aseptic and biosafety techniques while handling potentially infectious material in compliance with OSHA and Takeda safety standards.
- Supported process improvement initiatives to enhance accuracy, reduce sample errors, and streamline workflow in sample management operations.
Education
Master of Science - Pharmaceutical Sciences
University of Massachusetts Lowell
Lowell, MA12-2026
Bachelor of Science - Applied Biomedical Sciences – Clinical Sciences
University of Massachusetts Lowell
Lowell, MA08-2024
Skills
- Good Clinical Practice (GCP) FDA & ICH Regulatory Compliance SOP Adherence CAPA Documentation
- Clinical Operations Patient/Donor Screening Informed Consent Support Data Accuracy & Integrity
- Biospecimen Processing Phlebotomy & Venipuncture Aseptic Technique Sample Labeling, Storage & Shipment
- Molecular & Analytical Methods: PCR, CRISPR, ELISA, HPLC, IR Spectroscopy
- Clinical Documentation EMR/EHR & Donor Information Systems Deviation & Audit Reporting
- Biostatistics Data Analysis Experimental Design Quality Assurance & Control
Certification
- Good Clinical Practice (GCP) Training
- CPR Certified
- CLIA Certified Technical Consultant
Core Competencies
- Regulatory Submissions (IRB/FDA/Amendments)
- Protocol Deviation & Adverse Event Documentation
- Informed Consent & Participant Screening
- Audit Preparation & Regulatory Binder Maintenance
- GCP/ICH Compliance & Clinical Documentation Systems
- Staff Training & Workflow Oversight
Timeline
Center Supervisor
BioLife Plasma Services (Takeda Pharmaceuticals)
02.2023 - Current
Senior Sample Processing Technician
BioLife Plasma Services (Takeda Pharmaceuticals)
08.2022 - 02.2023
Sample Processing Technician
BioLife Plasma Services (Takeda Pharmaceuticals)
06.2022 - 08.2022
Master of Science - Pharmaceutical Sciences
University of Massachusetts Lowell
Bachelor of Science - Applied Biomedical Sciences – Clinical Sciences
University of Massachusetts Lowell