Kimberly K. Shellum
Mankato
Summary
Diligent quality engineer with strong background in ensuring product excellence and process improvement. Skilled in root cause analysis, process optimization, and compliance with industry standards. Proven ability to collaborate effectively with teams, adapt to changing needs, and deliver impactful results. Skilled in root cause analysis and continuous improvement methodologies, bringing reliability and integrity to every task. Known for reliability, problem-solving skills, and commitment to quality.
Overview
10
10
years of professional experience
Work History
Quality Engineer
Medline Industries, LP
07.2019 - Current
- Monitor and maintain quality compliance regarding product and process qualifications within Skin Care Operations value streams.
- Conduct root cause investigations of non-conforming processes and products and draft reports.
- Enhance product quality by implementing rigorous inspection procedures and conducting thorough root cause analysis.
- Recommend and implement corrective actions and quality improvements of product and processes to ensure regulatory compliance and promote continuous improvement.
- Participate in product and process risk management activities.
- Review validation protocols and reports in accordance with the current policies and procedures.
- Review sampling techniques/methods/rationale and test methods to ensure appropriate for risk level.
- Approve quality content and complete assigned tasks in change control for products and processes.
- Mentor and provide direct support, monitor and maintain QC microbiology lab quality compliance regarding product and processes.
- Streamlined QA processes, resulting in increased efficiency and reduced time to market.
Microbiologist / Lab Technician
Coloplast Manufacturing US, LLC
01.2017 - 07.2019
- Perform daily microbiological assays on finished goods, raw materials and stability samples using ATP Rapid system as required.
- Establish and validate microbial test methods.
- Performs all related laboratory functions including media preparation, sample preparation, plating samples, incubating plates, reading plates and reporting results
- Maintain neat, orderly documentation of inspections and results.
- Investigate out of specification results to determine root cause and correctives actions.
- Perform and record all laboratory daily checks accurately and in a timely manner.
- Purchase necessary reagents, instrument parts and testing supplies.
- GLP/cGMP environment
- Follow regulatory requirements of cGMP, ISO, USP and Coloplast. Awareness of applicable guidelines and regulations including, but not limited to USP, ISO, FDA.
- Safely perform all activities in established timeframes.
- Knowledge of GLP and/or GMP testing, scientific applications, experimental design, and data evaluation.
- Perform analysis on in-process bulks and finished other materials as needed.
- Any duties necessary to promote efficient functioning of the Quality department or Skin Care Value Stream.
Organic Special Chemistry Technician
Minnesota Valley Testing Laboratories
09.2016 - 01.2017
- Perform all Special Chemistry Analyses including Extractions and Analyses by HPLC on GC Food and Feed Products for Vitamin E, Ascorbic Acid, Caffeine, Sugars, Folic Acid, Vitamin A, Vitamin B12, Feed Drugs, Benzoic Acid and Toxins according to SOPs
- Prepare Chemical Standards and Solutions according to SOPs
- Perform Dilutions
- Document Data into appropriate Logbooks and/or on Applicable Forms
- Utilize Waters Empower for Data Acquisition and Data Processing
- LIMS Data Processing and Calculations.
- Responsible for Calibration, Operation and Maintenance of Laboratory Equipment and Maintain Equipment Records
Environmental Organics Chemistry Technician
Minnesota Valley Testing Laboratories
11.2015 - 08.2016
- Perform Extractions and Concentrations of Environmental Soil and Water samples
- Wisconsin DRO/EPA DRO, 608 and 8081/8082 Pesticides, 8270 Base/Neutral/Acids and TCLP
- Perform Dilutions, Prepare Standards and Reagents.
- Proficient with Accelerated Solvent Extractor
- LIMS Data Processing and Calculations
Education
Bachelor of Science - Microbiology
Minnesota State University
Mankato, MN05.2015
Associate of Applied Science - Commercial & Technical Art
South Central Technical College
North Mankato, MN05.2000
Skills
- Analytical problem-solving skills
- Data-driven decision making
- Statistical analysis techniques
- Team collaboration skills
- Time management and prioritization
- Detail-oriented independent worker
- Strong verbal and written communication
- Quality processes
- Root cause analysis and risk assessments
- Development and implementation of quality improvement strategies
Timeline
Quality Engineer
Medline Industries, LP
07.2019 - Current
Microbiologist / Lab Technician
Coloplast Manufacturing US, LLC
01.2017 - 07.2019
Organic Special Chemistry Technician
Minnesota Valley Testing Laboratories
09.2016 - 01.2017
Environmental Organics Chemistry Technician
Minnesota Valley Testing Laboratories
11.2015 - 08.2016
Associate of Applied Science - Commercial & Technical Art
South Central Technical College
Bachelor of Science - Microbiology
Minnesota State University
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