Lanet Grantham
St Louis,MO
Summary
Principal Consultant utilizing quantitative analysis tools to investigate problems thoroughly before developing comprehensive solutions, tailored specifically to each individual business need. Excels at presenting complex information in easy-to-digest format, allowing clients to make informed decisions quickly.
Overview
22
22
years of professional experience
Work History
Principal Consultant
CAI-MSD
01.2024 - 02.2024
- Generated strategy to facilitate gap closure before inspections
- Quality Inspection and Visual Inspection support during manufacturING canine vaccine in aseptic manufacturing facility
- Execute deviation, root cause analysis, and other associated documentation reviews and approvals
- Reviewed and pre-approved and/or approved documents and resolved compliance-related conflicts
- Manual Visual Inspection Support
- Support Root Cause Analysis investigation for Operator Diluent Product Qualification failures, including training and defect criteria determinations
- Support Root Cause Analysis investigation for Operator Diluent Product Qualification failures, including training and defect criteria determinations
- Development
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems
- Identify deviations from established product or process standards and provide recommendations for resolving deviations.
- Directed onsite training for business users to maximize productivity.
- Liaised with customers, management, and sales team to better understand customer needs and recommend appropriate solutions.
- Compiled research data and gave professional presentations highlighting finds and recommended optimizations
- Provided detailed advice to customers regarding deviation management system..
Validation Engineer
CAI-ThermoFisher
01.2022 - 11.2023
- Responsible for managing and coordinating multiple technical documentation and implementation for Sterilization of pharma-medical products
- Thirteen years managing and leading risk assessment, gap analysis, process mapping, and process validation in clinical and blood manufacturing
- Eight years leading qualification and validation for new and existing manufacturing processes, including developing validation plans and developing and executing qualification and validation protocols
- 15 years managing manufacturing and laboratory investigations
- Generating Change Controls and CAPA (Corrective and Preventive Action) Plans
- Project Manager of Viral Marker Testing Platform
- Managed ZIKA IVD Testing Implementation
- First Instructor of Haemonetics Testing at one of the leading blood manufacturing organizations in the country
- Create a curriculum for the Haemonetics program
- Project lead of Babesia Pool Testing
- Project Lead of Tecan Pooling Software Validation
- Participated in Pre-Approval Inspection (PAI)readiness activities by managing quality system metrics of Deviations.
- Documented entire validation process, noting changes or alterations completed.
- Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
- Participated in system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines.
- Managed and inspected instruments and equipment for manufacturing of phar products.
- Trained and assisted staff in validation techniques, methods and testing processes.
- Explained highly complex information in terms easily understood by non-technical personnel.
- Authored validation protocols for process systems, verifying compliance with internal policies and external safety requirements such as GMP,CGMP and CLIA .
- Collaborated on Standard Operating Procedure (SOP) development, incorporating input from quality assurance team to reduce liability and enhance successful deployments.
- Identified causes of equipment failures and made suggestions for issue resolution.
- Collaborated with cross-functional teams for identification and resolution of validation issues.
- Worked with stakeholders and team members on quality assurance efforts for hardware components.
- Monitored and reported on test results and performance data to identify areas of opportunity for improvement.
QC Equipment Coordinator
Mindlance-ThermoFisher
06.2021 - 12.2021
- Development and execution of Engineering documents, including Equipment Specification, User Requirements Specification, Factory Acceptance Test, System Impact Assessment, and Component Impact Assessment associated with a expansion of facilities
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems
- Develop validation master plans, process flow diagrams, or standard operating procedures
- Identify deviations from established product or process standards and provide recommendations for resolving deviations.
- Increased organizational efficiency by multitasking to foster timely project completion.
QC Equipment Coordinator
Mindlance
06.2021 - 12.2021
- Schedule all equipment services, coordinating with the contractor, and service provider of the metrology group, including but not limited to PM schedules, and calibration
- Asset management – commissioning of new QC (Quality Control) equipment, removal and/or disposal of all decommissioned QC-owned equipment
- Process service contact and renewals through AIRBA
- Finalized equipment maintenance using SAP (Statistical Analysis Plan) software
- Review the calibration/verification or PM data to ensure calibration of the equipment according to predetermined schedules and procedures
- Execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) Validation requirements
- Manage multiple projects
- Capital Appropriation Request.
Testing Supervisor
Creative Testing Solutions
08.2019 - 04.2021
- Lead FDA (Food and Drug Administration) inspections and Audits
- Experience with problem-solving tools (8D, 5-whys, cause, and effect
- Develop realistic solutions to meet customer needs and solve problems
- Strong Root Cause / Corrective Action skills
- Managed noncompliance activities using Track-wise Software
- Opened and Managed Change Controls
- Managed staffing levels and workflow mapping
- Managed and Mentored 25 direct report permanent and contract workers
- Create schedule plans for projects -punchline review.
- Gathered data on integration issues and vulnerabilities, reported findings and recommended improvements.
- Documented testing procedures for developers and future testing use.
- Authored and maintained well-organized, efficient and successful manual test cases for entire team.
- Completed pre-implementation testing for new system modifications to assess potential impacts.
- Incorporated delivery requirements into planning of testing schedules.
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
- Proven ability to develop and implement creative solutions to complex problems.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Delivered services to customer locations within specific timeframes.
Lead Technical Specialist
Creative Testing Solutions
02.2016 - 08.2019
- Prioritized, organized, and managed a high-volume workload efficiently Interpreting test results, including identification and correction of discrepancies
- Maintained effective communication with customers ensuring quality customer service and proper specimen testing protocol
- Proactively identified potential compliance concerns, effectively mitigating the need for problem escalation
- Devised and executed a routine biological sample testing program, including proper reagent preparation, pre-qualification, and quality assurance, ensuring prompt review and release of test results.
Quality Control Instructor
American Red Cross
10.2011 - 02.2016
- Adhered to a strict, time-sensitive training schedule across three production shifts to maintain employee competency compliance and regulation
- Maintained detailed competency assessments and staff training documentation records
- Conducted periodic retraining where quality or performance issues were noted and required system or process changes.
- Evaluated and revised lesson plans and course content to achieve student-centered learning.
- Tracked student progress, frequently checking in with struggling students and identifying root causes of problems.
- Initiated new learning methods, eliminating instructional gaps and improving comprehension.
- Facilitated learning with creation of engaging written and oral assignments.
- Oversaw curriculum development and implementation in alignment with best practices.
Quality Control Manufacturing Technologist
American Red Cross
04.2009 - 10.2011
- Performed Preventative Maintain and Calibrations of the BacT Alert System
- Trained staff on proper aseptic technique
- Managed recalls of reactive platelet products
- Performed automated and manual test procedures on blood samples to ensure the safety, potency, and purity of the blood supply
- Aided in the identification of potential problems and errors, troubleshooting, and implementing corrective actions.
- Calibrated machines to maintain required productivity levels and adherence to quality standards.
- Examined incoming materials and compared to documentation for accuracy and quality.
- Inspected products and machines to maintain quality and efficiency.
- Mapped process workflows to enhance understanding of procedures.
- Developed automation tools to improve efficiency, eliminate waste and free up labor hours for other needs.
- Managed quality assurance initiatives.
- Prepared reports and technical documentation of day-to-day production processes.
- Developed and enhanced personnel work instructions to clear up confusion and boost performance.
- Scheduled preventive and predictive maintenance actions based on failure analysis.
- Performed general equipment maintenance and repair to minimize downtime.
Medical Technologist
Quest Diagnostics
05.2002 - 05.2007
- Demonstrated the ability to communicate test results effectively with physicians and supporting staff providing exemplary customer service
- Evaluated quality control within the laboratory using standard laboratory tests and measurement controls, maintaining compliance with CLIA, OSHA (Occupational Safety & Health Administration), safety, and risk management guidelines
- Process Improvement Achievement - Implemented a visual detection sample testing system, reducing turn-around time delays, and work redundancy by 80%.
- Maintained required laboratory supplies inventory, and verified viability of supplies prior to use.
- Followed laboratory protocols for specimen processing, analysis, and results reporting.
- Conducted chemical analysis of body fluids to determine presence of normal and abnormal components.
- Operated, calibrated, and maintained sophisticated instruments and equipment to facilitate quality laboratory and patient care operations.
- Analyzed laboratory findings to check accuracy of results.
- Employed microscopic techniques to collect and study blood samples to determine number of cells, morphology, and blood group, assessing compatibility for transfusion purposes.
- Trained and oriented new medical technologists to perform and interpret tests.
- Input medical tests and clinical results data into computer using LIMIS for storage and retrieval.
- Collected and reviewed patient medical histories to accurately interpret test results.
Education
Bachelor of Science - Biology
Freed-Hardeman University
2000
Skills
- Asset management
- ISO 9001
- Microsoft Excel
- Minitab
- Calibration
- Quality management
- SharePoint
- Root cause analysis
- SAP
- Project Coordination
- Technical Integration
- Technology Implementation
- Project Management
- Lean
- Six Sigma
- Lean manufacturing
- 5S
- Aseptic technique
- Process improvement
- CGMP (Current Good Manufacturing Practice)
- Product development
- Technical writing
- Supervising experience
- Microsoft Access
- FDA regulations
- Analysis skills
- Risk analysis
- Risk management
- Design controls
- Clinical laboratory experience
- Quality systems
- Change management
- Time management
- Manufacturing
- Microsoft Office
- Quality assurance
- Internal audits
- Visio
- ERP (Enterprise Resource Planning) systems
- Certification: Kneat End Power User
- Assessments
- Product Life Cycle Management
- Business Planning
- Best Practices Implementation
- Management Coaching
- Quality Assurance
- Continuous Improvement
- Timeline Development
- Project Analysis
- Change Management
- Forecasting and Reporting
- Client Relationships
- Customer Relationship Management
- Problem-Solving
- Processes and Procedures
- Work Planning and Prioritization
- Process Improvement
- Performance Assessments
- Strategic Planning
- Resource Allocation
- Employee Management
- Performance Tracking
- Client Requirements Assessment
- Failure Analysis
- Staff Management
- Cost Analysis
- Team Leadership & Development
Accomplishments
- Used Microsoft Excel to develop inventory and project deliverables tracking spreadsheets.
- Supervised team of 12 staff members.
- Documented and resolved reagent manufacturing error which led to preventing results of 5,000 inaccurate results to clients.
Timeline
Principal Consultant
CAI-MSD
01.2024 - 02.2024
Validation Engineer
CAI-ThermoFisher
01.2022 - 11.2023
QC Equipment Coordinator
Mindlance-ThermoFisher
06.2021 - 12.2021
QC Equipment Coordinator
Mindlance
06.2021 - 12.2021
Testing Supervisor
Creative Testing Solutions
08.2019 - 04.2021
Lead Technical Specialist
Creative Testing Solutions
02.2016 - 08.2019
Quality Control Instructor
American Red Cross
10.2011 - 02.2016
Quality Control Manufacturing Technologist
American Red Cross
04.2009 - 10.2011
Medical Technologist
Quest Diagnostics
05.2002 - 05.2007
Bachelor of Science - Biology
Freed-Hardeman University
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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