Lindsay McLamb
Raleigh,NC
Summary
Offering solid foundation in analytical thinking and meticulous attention to detail, ready to learn and develop in quality control environment. Brings understanding of scientific principles and laboratory techniques, with proficiency in data analysis and reporting. Ready to use and develop problem-solving and technical skills in Quality Assurance role.
Overview
20
20
years of professional experience
Work History
QC Analyst I & II (Microbiology & Biochemistry)
Novo Nordisk Pharmaceutical IFP
01.2014 - Current
- Product and component endotoxin recovery using kinetic chromogenic with biotek reader and endoscan software
- Microbiological identification (Vitek and Maldi-TOF, Microseq)
- Phenotypic/Infection control testing
- Membrane filtration
- Biological indicator testing
- Sterility testing using SKAN Isolator
- Growth Promotion with BSL-1 control strains
- Biological indicator testing
- Balance and pH meter use
- Writing Lab investigations and deviations using CAPA
- Change control process adding new and existing methods/materials
- Revise and Review SOP’s and management of methods
- Process improvements in test methods with LIMS
- IT system management (LIMS/PEMS/Quality docs)
- SAP knowledge for equipment management
- Nikon Eclipse and Olympus microscope use
- Projects for validation of new equipment and product transfers
- Created and revised procedures, checklists and job aids to reduce errors.
- Developed training materials, SOPs, and work instructions to supplement new team member onboarding.
- Edited, proofed, and critiqued internal documents to improve clarity.
- Evaluated emerging technologies for potential integration into existing QC processes, aiming at optimization opportunities.
- Streamlined testing processes for increased efficiency and accuracy in results.
- Analyzed quality and performance data to support operational decision-making.
- Recorded and organized test data for report generation and analysis.
- Performed tests and inspections to conform to established standards.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
- Drafted technical documents such as deviation reports, testing protocol and trend analyses.
QC Environmental Monitoring/ Lab Technician I&II
Novo Nordisk Pharmaceutical IFP
05.2005 - 01.2014
- Gown certified and monitoring in class A-100
- Prep agar plates for sampling
- Water collection
- Membrane filtration of water and product
- Process air testing
- Interpretation and data entry of agar plates using LIMS/PEMS
- Use of microscope for crystal identity
- Use of Autoclave and washer
- Media and rinse preparation for testing
- Train production in EM process
- LIMS/PEMS data management
- Shopfloor production experience
- Deviation writing and investigation
- Test method owner and procedure writing/reviewing
- Projects for validation of new equipment and product transfers
- Maintained a high level of accuracy in test results by following strict quality control procedures.
- Operated basic laboratory equipment such as balances, pH meter, microscopy, autoclave and washer.
- Maintained documentation on tests performed in lab.
- Contributed to a safe working environment by consistently following established safety procedures and guidelines within the lab setting.
- Trained new associates in laboratory procedures and standards.
- Collected and performed analytical testing on in-process product.
- Adapted quickly to changes in test protocols or methodologies, maintaining productivity during periods of transition.
- Assisted in the development of new laboratory methods, leading to increased testing capabilities.
- Participated in continuous improvement initiatives, contributing to the ongoing optimization of lab operations.
- Prepared reagents, media and solutions to use for laboratory testing and analysis.
- Maintained safe, tidy and organized laboratory environment for accurate test results.
- Trained new laboratory personnel to apply proper laboratory techniques and best practices.
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
- Recorded and analyzed data to produce reports of results.
- Troubleshot and resolved equipment and process issues.
- Operated and performed preventative maintenance on laboratory equipment and instruments.
- Set and oversaw quality assurance guidelines for laboratory work.
Education
Bachelor of Science - Industrial Technology, Bioprocess Manufacturing
East Carolina University
Greenville, NC12.2024
Associates of Science Transfer - undefined
Johnston Community College
Smithfield, NC12.2016
Associate of Applied Science - Environmental Science
Wake Technical Community College
Raleigh, NC06.2004
Skills
- Writing and reviewing procedures
- NovoGlow experience with Investigation and CR’s
- Projects adding new method/materials
- Clear concept of an environmental monitoring program
- Trained in three generations of SKAN Isolators
- Equipment ownership/troubleshooting (Biotek/Olympus microscope/Isolator)
- LIMS template builder and data integrity knowledge
- Microsoft Word, Excel, and PowerPoint knowledge
- Lab Hazardous waste and Industrial Safety knowledge
- Fact based decision making using cGMP, and GLP
- Good quality leadership, teamwork, and communication skills
- Work well with minimal supervision
- Analytical thinking
- Time management
- Team collaboration and leadership
- Attention to detail
- Documentation and reporting
- Project management
- Critical thinking
- Process improvements
- Data processing
- Continuous improvement
- Information gathering
- Root-cause analysis
- Regulatory compliance
- Trend analysis
- Data integrity assurance
- Analytical problem solving
- Data interpretation
- Database management
- Teamwork and collaboration
- Data analysis
- Problem-solving
- Excellent communication
Timeline
QC Analyst I & II (Microbiology & Biochemistry)
Novo Nordisk Pharmaceutical IFP
01.2014 - Current
QC Environmental Monitoring/ Lab Technician I&II
Novo Nordisk Pharmaceutical IFP
05.2005 - 01.2014
Associates of Science Transfer - undefined
Johnston Community College
Associate of Applied Science - Environmental Science
Wake Technical Community College
Bachelor of Science - Industrial Technology, Bioprocess Manufacturing
East Carolina University
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