Marrissa Spence
Summary
Results-driven analyst adept at helping companies improve operational efficiency, team productivity and employee motivation. Hands-on process improvement specialist with exceptional organizational, critical thinking and prioritization skills. Possessing 4 years of related experience and passion for contributing to business success.
Overview
5
5
years of professional experience
Work History
Quality Assurance Analyst
Pharmaron
Germantown, MD
06.2021 - Current
- Process mapping: streamlined Vendor Qualification Program and site 5S/Lean Program after leading end-to-end mapping of process and training 20+ end-users on new system.
- Developed and implemented training documentation and audit review program for over 100 employees resulting in 80% reduction in organizational response time to regulatory agency requests for information.
- Audits 5 different regulated bioanalytical laboratory processes supporting over 300 clients, ensuring data meets regulatory requirements for FDA drug approval.
- Assisted in quality management system software implementation (salesforce) and large data migration project, Liaised between quality assurance and other stakeholders, providing project updates.
- As Knowledge Manager, updated project manuals and technical documentation used by quality assurance team. Maintained SOP database with 100+ documents.
- As Inventory Asset Manager, maintained over 100 various instrumentation devices within excel database, tracking maintenance schedule.
- Maintained quality department metrics dashboard to track project statuses and present to global leadership.
Automation Scientist
Pharmaceutical Product Development LLC, PPD
Richmond, VA
08.2020 - 06.2021
- Led 5S/Lean quality control improvement initiative which identified bottlenecks and reduced downtime by 30%.
- Reviewed sample results, tables, and analytical reports for completeness and accurate representation of data and report findings. Prepared statements noting deficiencies with analytical data sets, recommended corrective measures to project leader in collaborative environment.
- Analyzed testing results based on established indicators, submitting findings to central lab database to support laboratory deliverables.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Consistently monitored gaps in lab business processes to reduce spending. Contributed to team discussions and new project initiatives to advance progress and optimize profitability.
Analytical Technician II
Eurofins PSS Insourcing Solutions
Richmond, VA
05.2018 - 07.2020
- Accurately quantified and analyzed raw data; diagnosed instrument issues, and scheduled vendor maintenance as needed
- Prepared documentation for audits Performed SOP revisions as needed to ensure compliance with regulatory standards.
- Performed secondary review of processed data/documentation; Maintained supply inventory for laboratory testing; Ensured laboratory space was maintained according to cGMP standards
- Trained 10+ direct reports on department procedures and policies to maximize department productivity. Participated in new process development and process optimization programs to enhance overall system capabilities
- Generated technical reports and other documentation to record analytical test results and report trending using dashboards
Chemistry Laboratory Technician
Techead
Richmond, VA
08.2017 - 05.2018
- Analyzed over 1000 smokeless tobacco samples using IC, LC-MS, GC-MS, and UPLC for method development and validation.
- Successfully executed validated methods for smokeless tobacco and e-vapor products to test for potency, impurities, and identity.
- Processed data which included reviewing chromatography and batch reports in detail to ensure project requirements were met. Reported any atypical data and executed action plans based on findings
- Maintained detailed notebook and electronic documentation for production and method development. Developed working instructions for new methods and training new technicians.
Education
Bachelor of Science - Science, Conc. Health And Professional Science
Virginia Commonwealth University
Richmond, VA05.2017
Skills
- 5S/Lean
- Microsoft Office 365
- Technical Liaising
- Quantitative, Analytical and Organizational skills
- Internal Stakeholder Management
- Requirement gathering
- Agile environment experience
- Program Management
Timeline
Quality Assurance Analyst
Pharmaron
06.2021 - Current
Automation Scientist
Pharmaceutical Product Development LLC, PPD
08.2020 - 06.2021
Analytical Technician II
Eurofins PSS Insourcing Solutions
05.2018 - 07.2020
Chemistry Laboratory Technician
Techead
08.2017 - 05.2018
Bachelor of Science - Science, Conc. Health And Professional Science
Virginia Commonwealth University