Jamara Amerson
Durham,NC
Summary
HIGHLY DRIVEN, ANALYTICAL & CLINICALLY EXPERIENCED pursuing opportunities in the biotech, pharmaceutical, or clinical industry. Strong ability to quickly become a Subject Matter Expert on new topics and concepts. Will create value through relationship building, effective leadership and strategic approaches to addressing business needs.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Clinical laboratory scientist 2
Almac Group
02.2023 - Current
- Perform PQ tasks as needed including but not limited to, Instrument Comparability, Positive Control Qualifications and Alternative Assessments
- Author and revise change controls, SOP’s, Validation Evaluations and Proformas
- Compile analytical data to be used for process monitoring
- Facilitate process improvement initiatives that streamline workflow across teams (Quality and Manufacturing)
- Analyze patient samples through qPCR
- Ensure lab cleanliness and safety standards are maintained according to regulatory bodies (e.g., ISO, CLIA, CAP)
- Perform QC measures using Spectrophotometry
- Record quality events and complete necessary corrective actions (QE/CAPA) including root cause analysis/impact assessments
- Perform QC testing on assay reagents and controls prior to batch release for clinical use
- Train other testing personnel to perform laboratory procedures/assays and act as a point of contact for troubleshooting
- Maintain good documentation practices
- Compile and analyze quantitative data to flag adverse trends
- Update stock inventory for assay controls and reagents to identity when ordering needs to occur
- Identify scheduling conflicts and propose alternative options to aide business needs.
Molecular Scientist
Mako Medical
08.2022 - 02.2023
- The test performed by the scientist involves DNA extraction, qPCR, and data analysis
- They will also utilize the LIMS system to process patient data and results
- This position will focus on SARS-CoV-2 (COVID19) patient testing
- The scientist must be comfortable working with infectious materials and have experience handling biohazardous materials
- Proficiency with wet lab activities, computers, robotics, and sample tracking are critical to success
- Conduct molecular biology experiments following established SOP and/or guidance of laboratory management
- Receive test samples according to SOPs
- Perform DNA/RNA extraction, quantifications, and gel QC per SOPs
- Perform PCR, PCR clean up, and DNA sequencing per SOPs
- Report experimental results to project managers in a timely manner
- Follow established quality management policies and GLP and GMP practices
- Perform other duties as assigned
- Perform verification on COVID-19.
Clinical project associate
ICON
11.2021 - 08.2022
- Integral part of the study team by providing administrative and project tracking support to PM and CTM with emphasis on supporting inspection readiness
- Knowledgeable of ICH GCP, appropriate regulation, and Client SOPs/Client systems
- Assist the project teams with the set-up, organization, and maintenance of clinical study documentation (e.g., Study Files, CRFs,etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival
- Share responsibility in the QC audits of clinical study documentation to ensure study files are always inspection ready
- Maintaining TMF by filing IRB, EC, and other study related documentation in a timely manner
- To assist project teams with trail progress tracking by updating the Clinical Trail Management systems
- Run, review, and analyze study reports for accuracy and work with the project teams to ensure updates are completed correctly and in a timely manner
- Assist with the coordination of various tracking reports, including but not limited to, team member and training
- Work in cross-collaboration with internal and external colleagues to meet project objectives and timelines
- To maintain client and patient confidentiality
- Create and distribute metric reports to identify gaps in documentation accuracy, completeness, and quality to initiate appropriate resolutions.
Laboratory Technologist
LabCorp
08.2020 - 11.2021
- Performs complex technical and non- technical high complexity testing and results analysis to established standard operations procedures and protocols
- Performs procedure for specimen handling and processing, test, analyses, reporting and maintaining records of patients evaluate results
- Verifies proper and consistent identification of specimens prior to and during all accessioning and processing steps
- Performs pending lists on specimens to ensure specimens are here on site also, to see if missing from the department
- Test specimens completely, accurately and within an established time frame
- Maintain proper Chain of Custody protocols to ensure tracking and identification of patient samples for processing, analysis, and documentation
- Demonstrate GLP and GCP compliance to promote the quality and validity of testing data
- Troubleshoot technical problems to resolve issues that can adversely impact test performance or reporting of results.
Quality Inspector
Uchiyama America Inc
05.2013 - 08.2014
- Inspect incoming materials and products to ensure they meet quality standards
- Monitor production processes to ensure they are in compliance with quality standards
- Test products and materials to ensure they meet specifications
- Document inspection and test results
- Investigate customer complaints and take corrective action
- Identify and report quality issues to management
- Develop and implement quality control procedures
- Train and supervise other quality control staff
- Monitor and maintain quality control records
- Analyze data to identify areas for improvement
- Participate in internal and external audits
- Ensure compliance with applicable laws and regulations.
Education
BACHELOR of Science - Forensic science
Fayetteville State University
Fayetteville, NC05.2019
Skills
- MS Office
- Data Reconciliation
- Reports and Metrics
- QC/QA Audits
- ETMF Management
- EDC: Firecrest
- Veeva Vault
- LIMS (LabVantage)
- Q-Track (QMS)
- TrackWise (QMS)
- Troubleshooting & Problem solving
- Detail Oriented
- Cross- Team Collaboration
- Multitasking & Organization
- Effective Time & Financial Management
- Verbal Communcation
Certification
Advanced ICH GCP Certification
Timeline
Clinical laboratory scientist 2
Almac Group
02.2023 - Current
Molecular Scientist
Mako Medical
08.2022 - 02.2023
Clinical project associate
ICON
11.2021 - 08.2022
Laboratory Technologist
LabCorp
08.2020 - 11.2021
Quality Inspector
Uchiyama America Inc
05.2013 - 08.2014
BACHELOR of Science - Forensic science
Fayetteville State University
Advanced ICH GCP Certification
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