Kyle Nickels
Bryan,TX
Summary
Experienced Senior Quality Analyst with over 13 years of industry expertise in cGMP. Demonstrates exceptional leadership skills, holding various leadership positions for more than 15 years across diverse working environments. Thrives on challenges and quickly adapts to new settings. Goal-oriented professional committed to delivering results.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Senior Quality Analyst
FUJIFILM Diosynth Biotechnologies
12.2022 - Current
- Engage in Deviation Review Boards (DRB).
- Conduct writing, review, and assessment tasks to support Trackwise records.
- Assist in root cause analysis and determining corrective and preventative actions
- Perform comprehensive reviews and approvals of GMP documentation during pre and post execution phases.
- Cross functional collaboration for process improvements and document revision through Master Control.
- Conduct thorough evaluations of audit trails for various systems and equipment.
- Provide cGMP guidance to operations, QC and QA
- Support process readiness and disposition initiatives.
Quality Analyst III
FUJIFILM Diosynth Biotechnologies
12.2021 - 12.2022
- Review and approval of executed GMP documentation
- Support Trackwise Deviation review
- Provide cGMP guidance to operations, QC and QA
- Conducted thorough inspections of manufacturing areas.
- Provided assistance during regulatory, client, and internal audit processes.
Fluid Bed Functional Lead
Catalent Pharma Solutions
03.2019 - 12.2021
- Participates in daily Event Review Board meetings.
- Assisted in event and deviation investigations, focusing on writing and root cause analysis.
- Led Corrective and Preventative Actions initiatives.
- Reduced turnaround times by 25% through process enhancements during fiscal year 2021.
- Optimized various processes to improve efficiency.
- Directed processing suites to achieve assigned metric goals while maintaining SQDC standards.
- Engage in daily discussions with site leadership.
- Use of Trackwise and JDE inventory systems.
- Supervised team adherence to cGMP practices and FDA norms.
- Executed thorough checks on equipment and rooms following cleaning activities.
- Coordinate daily activities on the production floor.
- Supported supervision in managing daily activities of the fluid bed team, including staffing and workflow.
Fluid Bed Room Lead
Catalent Pharma Solutions
12.2014 - 03.2019
- Oversaw processing suites to achieve metric-based objectives.
- Facilitated cross-departmental collaboration.
- Conducted diverse tasks related to inventory control.
- Maintained strict adherence to cGMP guidelines and FDA regulations.
- Guided staff through new operational methods.
- Supported staff in achieving proper task fulfillment.
- Executed new methodologies leading to various advancements.
- Engaged in cross-functional team-building activities.
- Diagnosed issues, conducted analysis and delivered solutions to problems.
- Increased customer satisfaction by resolving various process issues during project and registration work.
Operations Team Leader
Alltech Algae
04.2011 - 12.2014
- Led upscaling of numerous Algae cultures to reach nearly 300,000 liters from an initial 40-liter setup.
- Accomplish nightly duties correctly within set time limits.
- Instruct personnel on proper cleaning and documentation methods.
- Maintained strict compliance with cGMP guidelines.
- Ensured compliance with housekeeping regulations, performed audits on documentation, monitored raw material weights, and relayed critical information to both colleagues and management.
- Monitored various systems such as boilers, air compressors, chilled water, hot water, raw material containment ensuring optimal functionality.
- Preventative maintenance on fermentation vessels and support systems.
Education
Some College (No Degree) -
Eastern Kentucky University
Richmond, KYSkills
- Document Review
- Attention to Detail
- Lean manufacturing processes
- Root Cause Analysis
- Quality assurance strategies
- Six sigma methodology
- Interdepartmental Communication and Collaboration
- Multitasking abilities
- Leadership
- Training
- Good Manufacturing Practices
Certification
Six Sigma Green Belt, Council for Six Sigma Certification - 2024
Timeline
Senior Quality Analyst
FUJIFILM Diosynth Biotechnologies
12.2022 - Current
Quality Analyst III
FUJIFILM Diosynth Biotechnologies
12.2021 - 12.2022
Fluid Bed Functional Lead
Catalent Pharma Solutions
03.2019 - 12.2021
Fluid Bed Room Lead
Catalent Pharma Solutions
12.2014 - 03.2019
Operations Team Leader
Alltech Algae
04.2011 - 12.2014
Six Sigma Green Belt, Council for Six Sigma Certification - 2024
Some College (No Degree) -
Eastern Kentucky University
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