Kellee Ramirez
Oceanside,CA
Summary
Quality control professional experienced in developing organization's quality strategy, procedures and processes. Monitor quality performance from supply chain and throughout product development life cycle. Develop and sustain Quality Management System in accordance with ISO 9001 and other applicable standards and business requirements. Manage quality audit program to identify and resolve non-conformities and embed culture of continuous improvement. Featured in Forbes Magazine article “Biotechnology Industry Gets A Boost From Community College Degrees”.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Quality Control Manager
Gallant Inc.
07.2022 - Current
- Assist in the development and implementation of Environmental Monitoring system
- Execution and implementation of in house USP testing and result interpretations
- Assist in the research and development of an improved cell culture media resulting in higher passage numbers, lower pd/day, higher cell yield and higher cell viability
- Assist Quality Assurance, Analytical Development and Process Development with other projects and tasks, where applicable
- Responsible for the day-to-day operations within the QC group in compliance with current GMP regulation and policies
- Assisting with Clinical stage activities including QC testing for raw materials, in-process, drug substances, drug products, finished product release, stability testing, and packaging materials and components
- Review all Quality Control related documents in support of drug substance, drug products, stability protocols/reports, and specifications
- Support QC testing activities for GMP and non-GMP manufacture of drug substance and drug product
- Assist and advice on method development/transfer, method validation, release testing, reference standard qualification, investigations for OOS/OOT results, etc
- Ensure all testing is completed and recorded according to Good Documentation Practices and relevant SOPs
- Ensure all QC activities are in accordance with regulatory and industry guidance, where applicable using a phase appropriate approach
- Create and/or revise QC lab SOPs, STMs, and other procedures for the QC function
- Write and review Change Controls, CAPA’s, QC deviation reports, and participate in out of specification (OOS) and out of trend (OOT) investigations
- Perform thorough data review in a timely and effective manner.
Laboratory Manager/Lead Manufacturing Associate
Cellipont Bioservices
02.2021 - 04.2022
- Initiate and develop a company safety council, reducing workplaces injuries and increasing employee engagement within the company
- Initiate and lead process improvements that affect immediate operations and may also have company-wide effect
- Review policies and procedures and assist with authoring any required changes
- Creative and efficient organizational skills and technical strategies
- Build and maintain strong vendor/supplier management skills and relationships which helped to streamline communication and provide faster answers for clients
- Implemented and maintained in house sterility testing allowing the company to save money and release product faster
- Manage the shifting priorities of the laboratory, production, and manufacturing daily tasks allowing for an overall growth in employee training completion and client satisfaction
- Create a learning environment for the laboratory staff to be able to identify a problem and provide multiple solutions, so they feel empowered and can grow to their fullest potential
- Ensures laboratory equipment and infrastructure are operating in a state of control receiving the highest marks received on an internal audit
- Provide technical guidance, support and solutions for multiple complex issues while occurring during manufacturing operations, helping to reduce the amount of consulting hours needed
- Perform monthly inventory cycle counts for laboratory consumables, materials and supplies
- Develop and maintain performance metrics for personnel and communicate department progress to management and staff
- Perform gap assessments, identify and mitigate risks as they pertain to laboratory operations that could negatively impact delivery of safe and effective therapies to patients.
Manufacturing Assistant
VetStem Biopharma
12.2020 - 02.2021
- Aseptically initiate, monitor and maintain multiple client's cell cultures for various species
- Sharing this knowledge with the laboratory team so communication and engagement stays open
- Knowledge of complete cell culture process of mammalian cells, both adherent and suspension types
- Perform various cell counting methods with various cell counting equipment
- Ability to execute primary cell isolation and cell culture in an aseptic processing environment without antibiotics
- Process adipose tissue for stem cell therapy and cell cultures
- Perform cryopreservation of stem cells, including formulation freezing medium
- Assists the operation of a state-of-the-art GMP cell manufacturing plant in accordance with FDA, ISO, Environmental Health & Safety, Human Resources, EMA regulations and other Quality System regulations, as applicable
- Ensures production area, processes and procedures are maintained in compliance with internal and external compliance and operating standards
- Maintains a strong culture of safety, quality, accountability, cost efficiency, on time delivery and customer service
- Ensures relevant manufacturing data are captured appropriately and accurately for supporting regulatory filings for clinical trials.
Surgery Scheduler
Scripps Health
01.2013 - 06.2017
- Supervised ten team members, including scheduling, training and evaluating performance
- Developed Excel spreadsheet to monitor Accounts Receivable
- Ensured charting accuracy through precise documentation while maintaining HIPA compliance
- Assisted in implementation of new tracking system that resulted in improved patient care
- Advocated for a systematic position/title update, resulting in a department wide pay raise and title promotion.
Education
Bachelor of Science - Biomanufacturing
Mira Costa College
Oceanside, CA05.2021
Skills
- Preventive Actions
- Quality processes
- Operational Excellence
- Documentation Control
- Regulatory knowledge
- Compliance understanding
- Six Sigma Methodologies
- Employee Supervision
- Employee Training
- Data Collection
- Performance monitoring
- Raw Material Inspection
- Manufacturing Processes
Accomplishments
- Achieved 90% cost savings by implementing in house USP sterility testing.
- Used Microsoft Excel to develop inventory tracking and result trending spreadsheets for quality department.
- Documented and resolved Microbial Investigation Reports which led to a more robust and comprehensive cleaning program and fewer microbial growth incidents.
- Achieved implementation of product stability program through effectively helping with authoring protocols and assisting with execution of processes.
- Achieved successful product lot releases through effectively helping with reviewing batch records and issuing certificate of analysis and certificate of conformances.
- Collaborated with manufacturing, upper management and research and development teams in the submission of Type 2 and type 5 CMC submission.
Certification
- President of ISPE Mira Costa College Chapter
- Certificate of Achievement in Biotechnology Research and Development with Honors, May 2019
- Certificate of Achievement in Bioprocess Technology with Highest Honors, May 2019
- SixSigma Lean Green Belt Certification 2020
- NordsonBuilds Scholar 2019, 2020
Education Certifications
Bachelor of Science, Biomanufacturing, 05/2021, Mira Costa College, Oceanside, CA
Timeline
Quality Control Manager
Gallant Inc.
07.2022 - Current
Laboratory Manager/Lead Manufacturing Associate
Cellipont Bioservices
02.2021 - 04.2022
Manufacturing Assistant
VetStem Biopharma
12.2020 - 02.2021
Surgery Scheduler
Scripps Health
01.2013 - 06.2017
Bachelor of Science - Biomanufacturing
Mira Costa College