Summary
Overview
Work History
Education
Skills
Timeline
Generic

Katie Donnelly

Holley,NY

Summary

Quality Analyst in Microbiology, offers six years experience in the medical and pharmaceutical industries. Extensive experience in compliance with GDP/GLP/GMP regulation, technical writing, microbial testing, validation and environmental monitoring. Possesses strong analytical skills and a robust work ethic. Exhibits a strong proficiency in recognizing quality concerns and initiating NCs, LIRs, and Deviations.

Overview

6
6
years of professional experience

Work History

Quality Analyst I

QuidelOrtho, Trison Business Solutions
04.2022 - 12.2023
  • Experience in aseptic technique
  • Ensuring compliance per company’s SOPs and regulatory standards
  • Participating in internal audits and walk-throughs focusing on safety concerns, ensuring both GMP and GLP
  • Performing internal investigations (IRs, LIRs, Deviations)
  • Elevating quality concerns to management and operations as needed
  • Assisting and providing support for validation of new manufacturing facility and its equipment (IQ/OQ/PQ)
  • Performing microbial preliminary identifications (i.e Gram Stain)
  • Communicating with vendors and ordering required material for laboratory
  • Performing growth promotion on supplier media
  • Assisting with onboarding of new team members
  • Experience with data management quality systems (i.e LIMS)
  • Developed training materials to supplement new team member onboarding.
  • Revised SOPs and laboratory forms to reduce errors.
  • Liaised with outside vendors to optimize cost effective laboratory materials
  • Liaised between operations and management to ensure quality of product
  • Addressed non-conformance issues, pausing production to correct errors.
  • Participated in departmental meetings to establish short- and long-term strategy and foresight
  • Collaborated with management to provide training on improved processes and assisted with creation and maintenance of quality training.
  • Defined and implemented quality initiatives to reduce risk.
  • Collaborated with cross-functional teams to develop and implement targeted solutions for identified quality issues, ensuring continuous improvement.
  • Edited, proofed and critiqued internal documents to improve clarity.
  • Evaluated function, performance and design compliance of every product against design standards and customer needs.
  • Developed and maintained quality assurance procedure documentation.
  • Led root cause analysis initiatives that resulted in significant reduction in recurring defects.
  • Standardized inspection criteria across multiple product lines, ensuring consistent quality evaluation and control.
  • Championed a proactive approach to problem-solving within the team, fostering an environment of collaboration and innovation.
  • Developed strong communication and organizational skills through working on group projects.
  • Paid attention to detail while completing assignments.
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
  • Gained extensive knowledge in data entry, analysis and reporting.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Worked effectively in fast-paced environments.
  • Excellent communication skills, both verbal and written.
  • Identified issues, analyzed information and provided solutions to problems.
  • Passionate about learning and committed to continual improvement.
  • Developed strong organizational and communication skills through coursework and volunteer activities.
  • Worked well in a team setting, providing support and guidance.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Participated on internal quality walk-through audits and assessed results to inform corrective action measures.

Microbiology Technician III

IUVO BIOSCIENCE
10.2020 - 04.2022
  • Experience in environmental monitoring, bioburden, sterility, and population testing
  • Coordinating and scheduling testing via Smartsheet and Excel, ordering media, ensuring adequate staff on site to complete testing
  • Experience drafting memorandums, and large-scale project data forms/final reports
  • Demonstrated communication skills; liaison between departments (login, purchasing, technicians and department management)
  • Sending product back to sponsors
  • Final reviewer for environmental monitoring data and sterility testing, data forms and final reports; focused on completion, accuracy GLP and GDP
  • Drafting and issuing reports to clients
  • Department contact for sterility, population testing and environmental monitoring Initiating and performing internal investigations (i.e
  • Deviations, NCs, CAPAs and LIRs) per work instruction to support department
  • External communication, addressing concerns and answering questions regarding projects
  • Performing additional testing based on client needs to support data from sterility tests
  • Extensive experience performing serial dilutions, plating, aseptic technique, sterility gowning etc
  • Equipment mapping and annual assessment of equipment (ValSuite).
  • Provided training and mentorship to new technicians, contributing to their professional growth and overall success of the team.
  • Tested chemical products to monitor reactions for quality assurance purposes.
  • Collaborated with cross-functional teams to deliver timely and accurate results for various projects within the organization.
  • Supported research projects by preparing microbiological samples, maintaining accurate records, and assisting with data analysis.
  • Boosted team efficiency by organizing, restocking and maintaining laboratory environments and equipment.
  • Maintained a clean and organized work environment, adhering to best practices for laboratory safety and hygiene.
  • Increased accuracy of test results through careful adherence to standardized testing methods and quality control measures.
  • Enhanced laboratory efficiency by streamlining sample processing and data management procedures.
  • Conducted comprehensive literature reviews to stay current on latest advancements in microbiology techniques and technologies.
  • Inspected and calibrated pH meters, spectrophotometers and centrifuges.
  • Reduced contamination risks by implementing strict aseptic techniques during all laboratory procedures.
  • Grew microbe cultures in different media.
  • Efficiently managed inventory of supplies and reagents, ensuring adequate stock levels while minimizing waste.
  • Coordinated safe disposal of unwanted chemicals and cleaning apparatus.
  • Optimized lab processes through regular review of protocols, identifying areas for improvement and implementing necessary changes.
  • Monitored staff actions and laboratory procedures, protecting integrity of collected research.
  • Recorded, analyzed, and interpreted data.
  • Exercised leadership capabilities by successfully motivating and inspiring others.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Paid attention to detail while completing assignments.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Strengthened communication skills through regular interactions with others.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Organized and detail-oriented with a strong work ethic.
  • Demonstrated leadership skills in managing projects from concept to completion.
  • Worked effectively in fast-paced environments.
  • Gained extensive knowledge in data entry, analysis and reporting.
  • Skilled at working independently and collaboratively in a team environment.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
  • Self-motivated, with a strong sense of personal responsibility.
  • Passionate about learning and committed to continual improvement.
  • Helped scientific and engineering teams improve research by sharing knowledge.
  • Improved lab safety by conducting regular equipment inspections and implementing updated protocols.
  • Participated in audits by regulatory agencies, demonstrating compliance with all applicable rules and regulations governing laboratory operations.

Clinical Data Assistant (Research Associate)

ROCHESTER REGIONAL HEALTH/ACM GLOBAL LABORATORIES
04.2020 - 10.2020
  • 5 months experience handling subject data for clinical trial studies
  • Responsibilities: Communicating with clients, addressing, and resolving discrepancies with data
  • Finalizing results for clinical studies
  • Escalating issues to Project Managers as needed
  • Updating internal and client database systems
  • Focused on data quality and management.
  • Employed methods of identifying information, business and technical requirements to meet user complex and unique health information and technology needs.
  • Reduced errors in data entry through consistent attention to detail and adherence to standardized procedures.
  • Integrated decision support, clinical pathways and best practices into health information technology to enhance delivery of care and workflows.
  • Operated computer-based systems to retrieve and store information and records.
  • Provided ongoing support during study audits by promptly addressing queries and supplying necessary documentation as required.
  • Incorporated quality improvement and safety-enhancing methodologies and tools to improve workflow processes,
  • Contributed to the development of comprehensive study protocols, supporting efficient execution of clinical studies.
  • Implemented effective tracking systems to monitor progress across all aspects of assigned trials, enabling proactive identification of potential issues or delays in research timelines.
  • Managed digitization of paper records.
  • Managed multiple projects simultaneously while adhering to strict deadlines, ensuring smooth progression of each study''s lifecycle.
  • Supported timely resolution of discrepancies in source documents by liaising with relevant stakeholders for clarification or verification purposes.
  • Ensured accurate data entry, contributing to the successful completion of numerous clinical trials.
  • Served as liaison between end-users and health IT team.
  • Performed medical records management, including filing, organizing and scanning documents.
  • Researched and validated clinical data.
  • Coordinated closely with site personnel to ensure rapid query resolution and accurate data collection, streamlining the monitoring process.
  • Ran quality metrics reports to maintain high standards of virtual care.
  • Evaluated and optimized clinical software, applying established and end-user feedback.
  • Maintained compliance with industry regulations and guidelines, upholding a high standard of data integrity throughout the clinical trial process.
  • Utilized advanced database software to manage large volumes of complex clinical data efficiently and accurately.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Skilled at working independently and collaboratively in a team environment.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Strengthened communication skills through regular interactions with others.
  • Passionate about learning and committed to continual improvement.
  • Gained strong leadership skills by managing projects from start to finish.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Developed strong organizational and communication skills through coursework and volunteer activities.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Worked effectively in fast-paced environments.
  • Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns.

Laboratory Technician

HIGHPOWER VALIDATION AND LAB SERVICES
06.2017 - 04.2020
  • 2 ½ years experience validating reusable medical equipment
  • Experience generating data forms and writing cleaning validation protocols
  • Performing medical device cleaning studies per manufacturer’s instruction for use, sterile efficacy, and material compatibility
  • Trained on properly utilizing steam sterilizers, H202 sterilizers, mechanical washers
  • Demonstrated good documentation techniques and practices
  • Following company and laboratory procedures
  • Generating protocol and data sheet templates
  • Managing multiple projects.
  • Trained new associates in laboratory procedures and standards.
  • Trained and supervised junior technicians in laboratory protocols.
  • Trained junior technicians on laboratory techniques and safety protocols, enhancing overall team proficiency.
  • Streamlined sample processing for faster turnaround times, resulting in improved customer satisfaction.
  • Assisted scientists by collecting and organizing laboratory data.
  • Trained new laboratory personnel to apply proper laboratory techniques and best practices.
  • Operated basic laboratory equipment such as balances, pH meter, colorimeter, spectrophotometer, autoclave and evaporator.
  • Prepared samples for analysis by performing complex sample preparation tasks.
  • Maintained documentation on tests performed in lab.
  • Calibrated and maintained instruments to keep equipment fully operational.
  • Adapted quickly to changes in test protocols or methodologies, maintaining productivity during periods of transition.
  • Completed quality documents and input and saved quality data in appropriate locations.
  • Inspected laboratory equipment to maintain good working condition for optimal results.
  • Developed new protocols and improved existing laboratory processes.
  • Enhanced laboratory efficiency by implementing new testing procedures and protocols.
  • Performed routine lab and department maintenance to keep area clean and orderly.
  • Maintained a high level of accuracy in test results by following strict quality control procedures.
  • Prepared reagents, media and solutions to use for laboratory testing and analysis.
  • Monitored and documented safety standards to verify compliance.
  • Operated and performed preventative maintenance on laboratory equipment and instruments.
  • Prepared reagents and solutions following standard laboratory formulas and procedures.
  • Functioned as primary data generator to record and calculate data and sign assay sheets.
  • Performed complex analyses using various instrumentation, delivering reliable data for informed decision making.
  • Interpreted laboratory results to provide technical advice to scientists.
  • Oversaw items in inventory and reordered before supplies diminished.
  • Increased sample throughput by optimizing workflow and efficient use of resources.
  • Collected and performed analytical testing on in-process product.
  • Adhered to laboratory safety procedures to maintain compliance with quality control standards.
  • Coordinated and managed laboratory projects and experiments.
  • Contributed to a safe working environment by consistently following established safety procedures and guidelines within the lab setting.
  • Interpreted and documented results of tests into active databases and communicated results to internal customers.
  • Reduced errors in data entry by meticulously reviewing and validating information before submission.
  • Tracked collected specimens by initialing, dating, and noting times of collection.
  • Maintained consumables and glassware inventory by receiving and inventorying incoming shipments.
  • Assisted in the development of new laboratory methods, leading to increased testing capabilities.
  • Collaborated with researchers and scientists to design and execute experiments.
  • Performed testing and quality control using approved laboratory procedures and instrumentation.
  • Cleaned and sterilized tools and equipment to maximize purity of specimens.
  • Provided support and guidance to junior lab staff.
  • Maintained safe, tidy and organized laboratory environment for accurate test results.
  • Kept abreast of current industry, scientific and regulatory developments and issues.
  • Conducted routine equipment maintenance, ensuring optimal performance and reducing downtime.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Acted as a team leader in group projects, delegating tasks and providing feedback.
  • Worked effectively in fast-paced environments.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Self-motivated, with a strong sense of personal responsibility.
  • Exercised leadership capabilities by successfully motivating and inspiring others.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Organized and detail-oriented with a strong work ethic.
  • Resolved problems, improved operations and provided exceptional service.
  • Delivered services to customer locations within specific timeframes.
  • Adaptable and proficient in learning new concepts quickly and efficiently.

Education

Bachelor of Science - Interdisciplinary Environmental Science

STATE UNIVERSITY OF NEW YORK AT FREDONIA
Fredonia, New York
12.2015

Skills

  • Strong analytical skills
  • Technical writing
  • Strong work ethic
  • Problem solver
  • Microsoft Office proficient
  • Excellent time management
  • GDP/GLP/GMP
  • Strong attention to detail
  • Highly organized
  • Materials Inspection
  • Continuous Improvement
  • Correction action planning
  • Risk Assessment
  • Laboratory Testing
  • Quality processes
  • SOP Development
  • Sampling
  • Project Management
  • Data Analysis
  • Quality Improvement
  • Project Planning
  • Test Scheduling
  • Problem-Solving
  • Analytical Thinking
  • QMS
  • Analytical Skills
  • Root Cause Analysis
  • Attention to Detail
  • Adaptability
  • Teamwork and Collaboration
  • Documentation skills
  • Problem-solving abilities

Timeline

Quality Analyst I

QuidelOrtho, Trison Business Solutions
04.2022 - 12.2023

Microbiology Technician III

IUVO BIOSCIENCE
10.2020 - 04.2022

Clinical Data Assistant (Research Associate)

ROCHESTER REGIONAL HEALTH/ACM GLOBAL LABORATORIES
04.2020 - 10.2020

Laboratory Technician

HIGHPOWER VALIDATION AND LAB SERVICES
06.2017 - 04.2020

Bachelor of Science - Interdisciplinary Environmental Science

STATE UNIVERSITY OF NEW YORK AT FREDONIA

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Katie Donnelly