Niesha Vines
Wendell,NC
Summary
Results-oriented professional with a passion for continuous learning and innovation. Skilled in analytical thinking and creativity to solve problems and deliver high-impact solutions in fast-paced environments. Proficient in data analysis, regulatory compliance, and process improvement, ensuring product reliability and consistency. Excel in critical thinking, problem-solving, and communication to achieve quality objectives through successful team coordination.
Overview
10
10
years of professional experience
1
1
Certification
Work History
<ul> <li>Analyzed results for accuracy, completeness, and compliance for batch releases.</li> <li>Contributed to laboratory investigations of events and OOS results</li> <li>Executed comprehensive testing for a variety of product types</li> <li>Updated various project-related documents including SOPs and technical reports</li> <li>Managed activity prioritization and ensured timely completion of continuous improvement projects.</li> <li>Led daily staff meetings focusing on performance metrics and goals</li> <li>Engaged in various technical training sessions to enhance the skillset.</li> <li>Trained team members on laboratory techniques and assays</li> <li>Organized work responsibilities through coordinated efforts in team meetings</li> </ul>
Pfizer Pharmaceutical
Sandford, NC
03.2023 - 10.2024
- Analyzed results for accuracy, completeness, and compliance for batch releases.
- Contributed to laboratory investigations of events and OOS results
- Executed comprehensive testing for a variety of product types
- Updated various project-related documents including SOPs and technical reports
- Managed activity prioritization and ensured timely completion of continuous improvement projects.
- Led daily staff meetings focusing on performance metrics and goals
- Engaged in various technical training sessions to enhance the skillset.
- Trained team members on laboratory techniques and assays
- Organized work responsibilities through coordinated efforts in team meetings
<ul> <li>Executed clean steam and water sampling for key sites</li> <li>Conducted raw material sampling and inspections</li> <li>Conducted serial dilutions using various types of pipettes effectively</li> <li>Facilitated investigative and QC operations adhering to business schedules</li> <li>Conducted thorough technical evaluations of data and documents for quality control units.</li> </ul>
Biogen Pharmaceutical
Morrisville, NC
01.2021 - 03.2023
- Executed clean steam and water sampling for key sites
- Conducted raw material sampling and inspections
- Conducted serial dilutions using various types of pipettes effectively
- Facilitated investigative and QC operations adhering to business schedules
- Conducted thorough technical evaluations of data and documents for quality control units.
<ul> <li>Executed thorough sampling for environmental assessment via active air and surfaces</li> <li>Executed tests to evaluate microbial presence in the environment</li> <li>Performed plate readings to detect bacteria and mold spore counts after incubation.</li> <li>Supported analytical assessment through testing</li> <li>Executed established sampling plans for environmental monitoring and gases</li> <li>Executed environmental PPQ efforts for clean steam systems and filling lines.</li> </ul>
CSL Seqirus (Artech)
Holly Springs, NC
03.2020 - 01.2021
- Executed thorough sampling for environmental assessment via active air and surfaces
- Executed tests to evaluate microbial presence in the environment
- Performed plate readings to detect bacteria and mold spore counts after incubation.
- Supported analytical assessment through testing
- Executed established sampling plans for environmental monitoring and gases
- Executed environmental PPQ efforts for clean steam systems and filling lines.
<ul> <li>Handled tracking and trending procedures within TrackWise effectively</li> <li>Ensured accuracy in documentation of Deviation, Corrective Action, and Preventive Action</li> <li>Regularly orchestrated comprehensive report writing on deviations</li> <li>Executed initial impact assessment for identified defects</li> <li>Collaborated with various cross-functional teams to align on quality targets</li> </ul>
Fresenius Kabi (Kelly Services)
Wilson, NC
06.2019 - 12.2019
- Handled tracking and trending procedures within TrackWise effectively
- Ensured accuracy in documentation of Deviation, Corrective Action, and Preventive Action
- Regularly orchestrated comprehensive report writing on deviations
- Executed initial impact assessment for identified defects
- Collaborated with various cross-functional teams to align on quality targets
<ul> <li>Performed regular audits on lab equipment</li> <li>Facilitated environmental data collection through diverse sampling methods</li> <li>Performed microbiological tests</li> <li>Monitored microbial counts through plate analysis after completion of incubation</li> <li>Performed release testing for product support, ensuring quality control</li> <li>Performed audits internally to confirm alignment with regulatory requirements</li> <li>Monitored technician compliance with aseptic standards in manufacturing</li> </ul>
Merck pharmaceutical (On Board Services)
Durham, NC
10.2018 - 05.2019
- Performed regular audits on lab equipment
- Facilitated environmental data collection through diverse sampling methods
- Performed microbiological tests
- Monitored microbial counts through plate analysis after completion of incubation
- Performed release testing for product support, ensuring quality control
- Performed audits internally to confirm alignment with regulatory requirements
- Monitored technician compliance with aseptic standards in manufacturing
<ul> <li>Supported startup initiatives for scientists and engineers</li> <li>Prepared operational components while adhering to gowning protocols</li> <li>Executed disassembly, assembly, and cleaning of manufacturing equipment</li> <li>Ensured optimal performance of industry-specific devices through technical proficiency</li> <li>Assisted with initial and ongoing equipment validation</li> <li>Contributed to initial stages of facility suite for scaling tabletop manufacturing project</li> </ul>
Thermo Fisher Scientific
Greenville, NC
01.2018 - 10.2018
- Supported startup initiatives for scientists and engineers
- Prepared operational components while adhering to gowning protocols
- Executed disassembly, assembly, and cleaning of manufacturing equipment
- Ensured optimal performance of industry-specific devices through technical proficiency
- Assisted with initial and ongoing equipment validation
- Contributed to initial stages of facility suite for scaling tabletop manufacturing project
<ul> <li>Performed complex laboratory tests on plasma and related items within GMP guidelines</li> <li>Facilitated necessary bioassay-related functions within GMP divisions</li> <li>Supervised timely issuance of bioassay test results</li> <li>Conducted serial dilutions using precise pipetting techniques</li> <li>Coordinated implementation of preventive measures</li> <li>Ensured accurate trend analysis of essential Quality Indicators</li> <li>Conducted technical training sessions for colleagues and new recruits</li> <li>Ensured precise analysis and documentation of field information</li> <li>Resolved technical challenges concerning laboratory machinery and operations.</li> <li>Ensured precision in test outcomes through continuous quality control assessments</li> </ul>
Grifols Pharmaceutical-
Clayton, NC
03.2015 - 01.2018
- Performed complex laboratory tests on plasma and related items within GMP guidelines
- Facilitated necessary bioassay-related functions within GMP divisions
- Supervised timely issuance of bioassay test results
- Conducted serial dilutions using precise pipetting techniques
- Coordinated implementation of preventive measures
- Ensured accurate trend analysis of essential Quality Indicators
- Conducted technical training sessions for colleagues and new recruits
- Ensured precise analysis and documentation of field information
- Resolved technical challenges concerning laboratory machinery and operations.
- Ensured precision in test outcomes through continuous quality control assessments
Education
Bio Works -
05/2016
05.2016
Bachelor of Science - Biology
08/2014
08.2014
Skills
- Proficient Technical Skills
- Quality Control Strategies
- Aseptic Testing/Sampling
- Data Trend Analysis
- Detail-Oriented
- Quality Management Systems
Certification
- OSHA 10
- Lean Sigma White Belt
References
References available upon request.
Timeline
<ul> <li>Analyzed results for accuracy, completeness, and compliance for batch releases.</li> <li>Contributed to laboratory investigations of events and OOS results</li> <li>Executed comprehensive testing for a variety of product types</li> <li>Updated various project-related documents including SOPs and technical reports</li> <li>Managed activity prioritization and ensured timely completion of continuous improvement projects.</li> <li>Led daily staff meetings focusing on performance metrics and goals</li> <li>Engaged in various technical training sessions to enhance the skillset.</li> <li>Trained team members on laboratory techniques and assays</li> <li>Organized work responsibilities through coordinated efforts in team meetings</li> </ul>
Pfizer Pharmaceutical
03.2023 - 10.2024
<ul> <li>Executed clean steam and water sampling for key sites</li> <li>Conducted raw material sampling and inspections</li> <li>Conducted serial dilutions using various types of pipettes effectively</li> <li>Facilitated investigative and QC operations adhering to business schedules</li> <li>Conducted thorough technical evaluations of data and documents for quality control units.</li> </ul>
Biogen Pharmaceutical
01.2021 - 03.2023
<ul> <li>Executed thorough sampling for environmental assessment via active air and surfaces</li> <li>Executed tests to evaluate microbial presence in the environment</li> <li>Performed plate readings to detect bacteria and mold spore counts after incubation.</li> <li>Supported analytical assessment through testing</li> <li>Executed established sampling plans for environmental monitoring and gases</li> <li>Executed environmental PPQ efforts for clean steam systems and filling lines.</li> </ul>
CSL Seqirus (Artech)
03.2020 - 01.2021
<ul> <li>Handled tracking and trending procedures within TrackWise effectively</li> <li>Ensured accuracy in documentation of Deviation, Corrective Action, and Preventive Action</li> <li>Regularly orchestrated comprehensive report writing on deviations</li> <li>Executed initial impact assessment for identified defects</li> <li>Collaborated with various cross-functional teams to align on quality targets</li> </ul>
Fresenius Kabi (Kelly Services)
06.2019 - 12.2019
<ul> <li>Performed regular audits on lab equipment</li> <li>Facilitated environmental data collection through diverse sampling methods</li> <li>Performed microbiological tests</li> <li>Monitored microbial counts through plate analysis after completion of incubation</li> <li>Performed release testing for product support, ensuring quality control</li> <li>Performed audits internally to confirm alignment with regulatory requirements</li> <li>Monitored technician compliance with aseptic standards in manufacturing</li> </ul>
Merck pharmaceutical (On Board Services)
10.2018 - 05.2019
<ul> <li>Supported startup initiatives for scientists and engineers</li> <li>Prepared operational components while adhering to gowning protocols</li> <li>Executed disassembly, assembly, and cleaning of manufacturing equipment</li> <li>Ensured optimal performance of industry-specific devices through technical proficiency</li> <li>Assisted with initial and ongoing equipment validation</li> <li>Contributed to initial stages of facility suite for scaling tabletop manufacturing project</li> </ul>
Thermo Fisher Scientific
01.2018 - 10.2018
<ul> <li>Performed complex laboratory tests on plasma and related items within GMP guidelines</li> <li>Facilitated necessary bioassay-related functions within GMP divisions</li> <li>Supervised timely issuance of bioassay test results</li> <li>Conducted serial dilutions using precise pipetting techniques</li> <li>Coordinated implementation of preventive measures</li> <li>Ensured accurate trend analysis of essential Quality Indicators</li> <li>Conducted technical training sessions for colleagues and new recruits</li> <li>Ensured precise analysis and documentation of field information</li> <li>Resolved technical challenges concerning laboratory machinery and operations.</li> <li>Ensured precision in test outcomes through continuous quality control assessments</li> </ul>
Grifols Pharmaceutical-
03.2015 - 01.2018
- OSHA 10
- Lean Sigma White Belt
Bio Works -
05/2016
Bachelor of Science - Biology
08/2014
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