Tiffaney M. Fomby
Elk Grove,USA
Summary
Results-driven Quality Control Analyst with expertise in stability testing and compliance at MilliporeSigma. Proven ability to enhance quality control processes and troubleshoot effectively. Skilled in SOP writing and data analysis, demonstrating strong independent work capability. Committed to maintaining ISO 13485 standards while ensuring product excellence and safety in a fast-paced environment.
Overview
13
13
years of professional experience
Work History
Manufacturing - Associate Technician
Beckman Coulter Life Sciences
West Sacramento, California
04.2025 - Current
- Operated machinery for assembly line production and ensured smooth workflow.
- Collaborated with team members to streamline production tasks and improve efficiency.
- Conducted routine equipment inspections to identify maintenance needs and prevent downtime.
- Implemented best practices for workplace safety, promoting a culture of compliance.
- Communicated effectively with supervisors regarding production status and potential issues.
- Clean work areas regularly to maintain a safe working environment.
- Communicated with co-workers to improve unit production.
- Donned safety glasses, gloves, and safety shoes to reduce injuries and accidents.
- Maintained production facilities at high standard of cleanliness and organization to improve quality of products.
- Set up and operate a variety of machinery used in the manufacturing process.
- Collaborate with other team members to improve production processes while ensuring safety protocols are followed at all times.
- Inspected finished products to verify conformance with customer requirements.
- Inspect raw materials prior to use in the assembly process to ensure they meet established standards.
- Maintain records of production, quality control, and machine maintenance activities.
- Escalated manufacturing issues to management and quality assurance to identify solutions.
- Record data from each shift for record keeping purposes as required by company policy.
- Identify defective components or finished goods items during the inspection process and make appropriate adjustments accordingly.
- Operate equipment such as forklifts, hand tools, power tools, and inspection gauges.
- Troubleshoot problems in the manufacturing process by identifying root causes and proposing solutions.
- Performed equipment maintenance and calibrations to drive accurate measurements and production of quality products.
Quality Control Analyst - Stability
MilliporeSigma (Cell Marque/Merck)
Rocklin, CA
03.2024 - Current
- Under moderate supervision, the Quality Control Analyst - Stability performs stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements; supports the day-to-day activities of the Quality department with adherence to applicable regulatory requirements, ISO 13485, local and global QMS.
- Perform stability testing of IVD and ASR products according to protocols, SOPs, and in compliance with local and global QMS and regulatory requirements.
- Analyze and interpret data resulting from the stability testing performed.
- Record and document testing results accurately and per applicable regulatory and SOP requirements.
- Data analysis using Microsoft Excel.
- Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines. Troubleshoot equipment problems.
- Recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process.
- Maintain cGMP compliance in the laboratory.
- Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to laboratory management.
- Must be willing and able to work on weekends or extended hours as needed.
- Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, compliance with the site Quality Manual.
- Other duties as assigned or required to support the business.
- ISO accredited antibody manufacturing company
Manufacturing Technician
Immuno Concepts
Sacramento, CA
10.2022 - 09.2023
- The Manufacturing Technician must carry out assignments in accordance with the quality system documentation and in a manner to achieve quality objectives and fulfill IC product quality requirements. Clear understanding of immunology, serological techniques and diagnostic assays is required. Specific experience and/or knowledge of general laboratory techniques and equipment is required. Cell culture and/or ELISA methodology experience is required.
- Maintain a clear understanding of the defined authority and responsibilities assigned and channels to take action.
- Perform all cell culture activities, including preparation of all cell culture media.
- Manufacture all conjugates, serum-based controls, calibrators, and in-house reagents for production, product and process improvement or product development activities.
- Monitor inventory levels and qualify sera and conjugate raw materials used in manufacturing.
- Perform all aspects of production and product manufacturing.
- Project and post cell culture and reagent needs for a given production schedule.
- Perform certifications, calibrations, and preventive maintenance on manufacturing equipment.
- Perform housekeeping duties as assigned.
- Assist in the monitoring and enforcement of safe laboratory techniques for laboratory personnel.
- ISO accredited medical diagnostics device manufacturing company
Laboratory Generalist III/PCR Technician
Antech Diagnostics
Sacramento, CA
06.2022 - 10.2022
- Receives and prepares samples for laboratory analysis and tests. Prepares samples, sets up instruments, runs tests and reads, interprets and releases results. May perform a variety of client service activities for internal and external stakeholders.
- This position requires proficiency in at least three clinical areas including Hematology.
- Perform and analyze results for the Total Parasite PCR panels and other non-PCR tests as required.
- Process samples and prepare samples for send out.
- Perform all required quality control per QA guidelines.
- Train on all areas to include Specimen Processing, Chemistry, Serology, UA, Coag and Parasitology according to all SOP’s.
- Oversee the entering and releasing of results.
- Responsible for building hematology and UA loads.
- Read UA slides at a minimum rate of 45 per hour.
Production Specialist
Immuno Concepts
Sacramento, CA
10.2021 - 06.2022
- This position performs all day-to-day duties of a Manufacturing Technician and a Product and Process Improvement Technician. The Production Specialist must carry out assignments in accordance with the quality system documentation and in a manner to achieve quality objectives and fulfill IC product quality requirements. Clear understanding of immunology, serological techniques and diagnostic assays is required. Specific experience and/or knowledge of general laboratory techniques and equipment is required. Cell culture and/or ELISA methodology experience is required.
- Initiate action to prevent the occurrence of any non-conformities relating to product, process, or quality system.
- Initiate, recommend or provide solutions to quality problems through designated channels.
- Identify and record any problems relating to the product, process, and quality system.
- Maintain a clear understanding of the defined authority and responsibilities assigned and channels to take action.
- Perform all cell culture activities, including preparation of all cell culture media.
- Manufacture all conjugates, serum-based controls, calibrators, and in-house reagents for production, product and process improvement or product development activities.
- Monitor inventory levels and qualify sera and conjugate raw materials used in manufacturing.
- Perform all aspects of production and product manufacturing.
- Project and post cell culture and reagent needs for a given production schedule.
- Perform and coordinate process change activities for the development of new product or processes.
- Project and procure materials as required for completing activities according to the project and planned schedules.
- Document product/process improvement and development projects and maintain files according to Quality System Procedures.
- Establish new procedures, work instructions and forms for new product/processes following established Document Control Procedures.
- Train personnel as required for new product/process transfer and implementation.
- Assist in troubleshooting production problems under the direction of the Production Area Authority.
- Maintain quality record files in accordance with documented procedures.
- Perform product development activities as scheduled.
- Perform certifications, calibrations, and preventive maintenance on manufacturing equipment.
- Perform housekeeping duties as assigned.
- Assist in the monitoring and enforcement of safe laboratory techniques for laboratory personnel.
- Ensure that quality records, documentation and work activities are compliant with IC Quality System.
- Assist in the enforcement of cGMP to maintain compliance with FDA QSRs, international regulatory requirements, and the established quality system.
- Develop Device History Files for IC products including, but not limited to, compliance with government regulations for market approval of new or modified products.
- Additional duties and responsibilities may be requested by Immuno Concepts executive management.
- ISO accredited medical diagnostics device manufacturing company
Product and Process Improvement Technician
Immuno Concepts
Sacramento, CA
06.2015 - 09.2021
- Performing research and coordinating/scheduling project activities for improvements to new and existing products used for the diagnosis of systemic rheumatic diseases.
- Develop and document product and/or process improvement projects and maintain files according to Quality Systems Procedures.
- Research and investigate new or improved products and processes in collaboration with the Area Supervisor and Chief Scientific Officer.
- Conduct investigations and experiments as needed.
- Establish new procedures, work instructions, and forms for new products/processes following established document control procedures.
- Train personnel as required for new product/process transfer and implementation.
- Prepare, perform, analyze and organize results of products for FDA 510(k) submission.
- Note: Trained and experienced in the manufacturing of several IC products starting Jan. 2021 to present.
- ISO accredited medical diagnostics device manufacturing company
Quality Control Technician
Immuno Concepts
Sacramento, CA
04.2014 - 06.2015
- Testing, assessment for acceptance, and release of incoming and manufactured products used to diagnose rheumatic diseases.
- Inspection and testing of incoming materials, pre-packaged materials, and packaged components according to proscribed procedures using microscopy and basic laboratory skills.
- Testing and qualification of new materials.
- Troubleshooting and investigating abnormal results.
- Participating in investigating production problems.
- Test systems include ANA substrate slides, DNA substrate slides, ANCA substrate slides, and RELISA.
- ISO accredited medical diagnostics device manufacturing company
Lab Technician
Weidmann Diagnostic Solutions Inc.
Sacramento, CA
04.2013 - 04.2014
- Quality assessment of dielectric fluids (e.g. mineral oil, natural & synthetic esters, silicone, and perchloroethylene).
- Tests include interfacial tension, color & visual inspection, acid number, dielectrics, oxidation inhibitor, microscopic inspection, power factor, moisture content and specific gravity all performed according to SOPs and under ASTM/IEC standards.
- Duties also include keeping records organized, computer data entry, supply labeling, lifting heavy objects (~ 50 lbs), waste handling, and keeping lab area equipment clean.
- ISO accredited production chemistry laboratory
Education
Bachelor of Science - Biomolecular Science
New York University Tandon School of Engineering
Brooklyn, NY01.2013
Skills
- Medical device expertise
- Supplier quality assurance
- Polymerase chain reaction (PCR)
- Standard operating procedure (SOP) writing
- Hematology and urinalysis
- Cell culture and harvest techniques
- Histological analysis
- Quality control processes
- Stability testing
- FDA quality system regulations (QSRs)
- Current Good Manufacturing Practices (CGMP)
- ISO 13485 compliance
- Enzyme-linked immunosorbent assay (ELISA)
- Bioburden assessment
- Immunohistochemistry (IHC) testing
- Independent work capability
- Computer proficiency
- Microsoft 365 applications
- Advanced Excel proficiency
- Data analysis techniques
- Troubleshooting skills
- Multitasking abilities
Timeline
Manufacturing - Associate Technician
Beckman Coulter Life Sciences
04.2025 - Current
Quality Control Analyst - Stability
MilliporeSigma (Cell Marque/Merck)
03.2024 - Current
Manufacturing Technician
Immuno Concepts
10.2022 - 09.2023
Laboratory Generalist III/PCR Technician
Antech Diagnostics
06.2022 - 10.2022
Production Specialist
Immuno Concepts
10.2021 - 06.2022
Product and Process Improvement Technician
Immuno Concepts
06.2015 - 09.2021
Quality Control Technician
Immuno Concepts
04.2014 - 06.2015
Lab Technician
Weidmann Diagnostic Solutions Inc.
04.2013 - 04.2014
Bachelor of Science - Biomolecular Science
New York University Tandon School of Engineering