JENNIFER Bernard
Cary,NC
Summary
Quality-focused life sciences professional with extensive experience supporting GMP laboratory operations, sample lifecycle management, and data integrity in regulated environments. Proven expertise in sample receipt, tracking, storage, chain-of-custody documentation, and LIMS-based workflows. Strong collaborator with laboratory analysts and Quality Assurance to ensure compliant, inspection-ready sample management processes supporting quality control testing.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Lab Operations Scientist / Team Lead
IQVIA Laboratories
Durham, NC
11.2023 - 11.2025
- Received, logged, and tracked clinical and QC samples in LIMS, ensuring accurate documentation and traceability throughout the sample lifecycle.
- Ensured proper labeling, storage conditions, and chain-of-custody documentation for samples used in regulated testing.
- Coordinated sample distribution to laboratory analysts to support timely and compliant testing workflows.
- Performed peer review of sample-related data to ensure data integrity and compliance with GMP requirements.
- Maintained sample inventories, monitored storage conditions, and supported timely disposal of completed or expired materials.
- Served as Deviations and Investigations Champion, supporting investigations related to sample discrepancies and documentation errors.
- Participated in audit readiness activities, providing traceability documentation and supporting inspection responses.
- Collaborated closely with Quality Assurance and laboratory teams to resolve sample issues and improve handling processes.
- Supported SOP adherence and contributed feedback for process improvements related to sample management activities.
CMMS Senior Administrator III
Biogen
Durham, NC
01.2022 - 07.2023
- Ensured data integrity and traceability of GMP assets and materials within controlled systems supporting QC and manufacturing operations.
- Collaborated with QA to ensure system workflows aligned with regulatory and documentation requirements.
- Supported inspection readiness by maintaining compliant records and controlled access to regulated systems.
- Trained cross-functional teams on proper documentation practices within GMP-controlled environments.
Study Coordinator (GMP)
BioAgilytix
Durham, NC
01.2021 - 12.2022
- Maintained compliant documentation supporting QC sample workflows
- Coordinated study materials and timelines to ensure testing readiness
- Supported deviation resolution and protocol adherence
Team Lead/Pipette Services
Pharmaceutical Calibrations and Instrumentation, LLC
Raleigh, NC
01.2011 - 02.2021
- Led daily operations for pipette calibration services within ISO-regulated environments, ensuring strict adherence to documented procedures and quality standards.
- Verified proper identification, tracking, handling, and documentation of customer instruments throughout the service lifecycle to maintain traceability and data integrity.
- Maintained accurate service records and calibration documentation in compliance with quality and regulatory requirements.
- Supervised and trained team members on SOP adherence, documentation practices, and compliance expectations.
- Supported internal and customer audits and inspections by providing complete calibration records and traceability documentation.
- Identified process gaps and implemented improvements to enhance workflow efficiency, compliance, and turnaround time.
- Collaborated with customers and internal teams to resolve discrepancies related to documentation, tracking, or service outcomes.
Cytogenetic Senior Technician
Genzyme Genetics
New York, NY
04.2007 - 06.2009
- Supported cytogenetic testing within a regulated laboratory environment, following established SOPs and quality requirements.
- Managed controlled samples from cell culture preparation through analysis, ensuring proper handling, identification, and documentation.
- Analyzed specimens using computerized imaging systems, maintaining accurate records and traceable data for final reporting.
- Prepared and reviewed analytical documentation to support quality review and report approval processes.
- Ensured compliance with documentation standards and data integrity requirements throughout sample analysis activities.
Senior Cytogenetic Technologist
Bio-Reference Laboratory
Elmwood Park, NJ
06.2005 - 04.2006
- Supported cytogenetic testing in a high-throughput, regulated clinical laboratory, adhering to established SOPs and quality requirements.
- Handled and analyzed controlled biological samples, ensuring proper identification, handling, and documentation throughout testing workflows.
- Generated and reviewed analytical records using computerized imaging systems to maintain accurate, traceable data for final reporting.
- Ensured compliance with documentation standards and data integrity expectations in support of quality review processes.
Cytogenetic Technologist
LabCorp
Durham, NC
04.2003 - 05.2005
- Supported cytogenetic testing in a regulated clinical laboratory environment, following SOPs and quality requirements.
- Handled and processed controlled biological samples, ensuring proper identification, handling, and documentation.
- Generated analytical records using computerized imaging systems, maintaining accurate and traceable documentation for final reporting.
- Maintained compliance with documentation standards and data integrity expectations in support of quality review processes.
Research Associate
University of Southern Maine
Portland, ME
04.2004 - 03.2005
- Supported research activities within a regulated laboratory environment, adhering to established procedures and documentation requirements.
- Coordinated and maintained controlled documentation and records to support regulatory and quality requirements.
- Managed inventory of laboratory materials and equipment, ensuring proper organization, tracking, and availability.
- Compiled, reviewed, and summarized data into reports and spreadsheets, maintaining accurate, traceable records for presentations and reviews.
- Supported equipment setup and laboratory organization in alignment with safety and compliance standards.
Research Assistant II
Yale University School of Medicine
New Haven, CT
04.2003 - 04.2004
- Supported research activities in a regulated laboratory environment, following established procedures and documentation standards.
- Coordinated and maintained controlled documentation and records to support regulatory and quality requirements.
- Compiled, reviewed, and summarized research data into reports and spreadsheets, ensuring accuracy, traceability, and data integrity.
- Assisted with preparation of materials and documentation for regulatory review and internal audits.
- Collaborated with laboratory staff to ensure organized workflows aligned with quality and compliance expectations.
Cytogenetics Technologist
Dianon Systems Inc
Stratford, CT
04.2001 - 04.2003
- Supported cytogenetic testing within a regulated clinical laboratory environment, following established SOPs and quality requirements.
- Handled and processed controlled biological samples, ensuring proper identification, handling, and documentation.
- Generated analytical records using computerized imaging systems, maintaining accurate and traceable documentation for final reporting.
- Maintained compliance with documentation standards and data integrity expectations in support of quality review processes.
Education
Bachelor of Science - Biology
North Carolina Central University
Durham, North Carolina, NC12-1996
Skills
- Sample Receipt, Handling & Chain of Custody
- Sample Inventory & Lifecycle Management
- GMP / GCLP / GLP Compliance
- Deviation & Investigation Support
Certification
- Lean Practitioner Certification , IQVIA Laboratories
- White Belt Certification, IQVIA Laboratories
Timeline
Lab Operations Scientist / Team Lead
IQVIA Laboratories
11.2023 - 11.2025
CMMS Senior Administrator III
Biogen
01.2022 - 07.2023
Study Coordinator (GMP)
BioAgilytix
01.2021 - 12.2022
Team Lead/Pipette Services
Pharmaceutical Calibrations and Instrumentation, LLC
01.2011 - 02.2021
Cytogenetic Senior Technician
Genzyme Genetics
04.2007 - 06.2009
Senior Cytogenetic Technologist
Bio-Reference Laboratory
06.2005 - 04.2006
Research Associate
University of Southern Maine
04.2004 - 03.2005
Cytogenetic Technologist
LabCorp
04.2003 - 05.2005
Research Assistant II
Yale University School of Medicine
04.2003 - 04.2004
Cytogenetics Technologist
Dianon Systems Inc
04.2001 - 04.2003
Bachelor of Science - Biology
North Carolina Central University
Lean Practitioner Certification
Applied Lean principles to improve standardized workflows, reduce process variation, and support right-first-time execution in regulated laboratory environments.