Kimberly Toole
Aiken ,SC
Summary
Experienced Lead Operator in an FDA-regulated facility with a solid 23-year track record of ensuring safe production and maintaining high-quality standards. Recognized for unwavering accountability, strong leadership skills, meticulous attention to detail, and unwavering commitment to customer satisfaction. Consistently exceeds expectations and maintains an above-standard work ethic.
Overview
24
24
years of professional experience
Work History
Lead Operator (FDA Regulated Facility)
Kimberly Clark Corp
01.2024 - Current
- Created a safety 1st culture within the team by identifying/Resolving safety hazards and followed 24/7 process.
- Promoted/utilized 3 obligations.
- Promoted/supported PBS, ETQ, and SIRA processes.
- Created a customer focus mindset within the team.
- Participated in continuous improvement initiatives, contributing ideas for process enhancements that resulted in measurable gains in performance metrics.
- Provided on-the-job training to newly hired workers and team members.
- Performed operator performance assessments, coaching and feedback.
- Key decision maker and responsible for team and line performance.
- Directed and coordinated all line activity and decisions.
- Assigned tasks to team members based upon individual strengths and experience, realizing productivity and workflow improvements.
- Performed and used on-shift audits to verify accuracy and completion of PASS quality checks and sanitization documentation.
- Maintained quality product through look and feel, completion of quality checks, process adjustments to bring attributes to target, and verified product through cull verification.
- Lead hourly escalation process.
- Supported/participated in Daily escalation process.
- Ensured all on shift SQDC systems and documentation were completed to standard.
- Provided detailed turnover to incoming Lead Operator.
- Attended Asset turnover meetings, provided input on machine status, helped establish Plan of the Day.
- Enforced and understand GMP requirements, verify compliance, and react on any non-compliance.
- Made tactical decisions for Machine Crew.
- Performed troubleshooting for top problems and escalated unresolved issues.
- Served as a subject matter expert, providing guidance and assistance to junior operators in troubleshooting equipment malfunctions.
- Ensured compliance with safety regulations, conducting regular audits and enforcing proper procedures at all times.
- Maintained proper machine centerlines, and verified process running to GRS daily.
- Documented and communicated and Process adjustments made during shift.
- Performed general equipment maintenance and repair to minimize downtime.
- Used problem-solving and issue-resolution skills to promptly and successfully address production problems.
- Maintained housekeeping in accordance with GMP standards.
Mastery Process Operator (FDA Regulated Facility)
Kimberly-Clark
01.2001 - Current
- Attend Tier meetings
- Support safety initiatives (PBS, ETQ, SIRA)
- Support 24/7 step, brand, grade change processes
- Support TPM principles in relation to standards and technical application
- Work cooperatively with others to help team achieve its goals
- Identify, analyze, and correct issues regarding equipment and process health
- Make decisions daily related to mechanical issues that could affect quality and production
- Support OPEX and TIP process
- Keep facility inspection-ready at all times through proactive housekeeping
- Inspect finished products for quality objectives and adherence to customer specifications
- Communicate effectively with Engineering and reliability on technical level
- Communicate effectively with team on technical level
- Adjust machines to increase productivity for runs
- Troubleshoot machine quality and process issues
- Use problem-solving and issue-resolution skills to promptly and successfully address problems
- Examine incoming materials and compared to documentation for accuracy and quality
- Maintain organized work area by cleaning and removing hazards utilizing 5S
- Provide/receive detailed information at shift turn-over and other meetings
- Provide training for new production staff members on safe and efficient production procedures and proper machine operations
- Meet production targets and tight deadlines by collaborating closely with team members
- Perform general equipment maintenance and repair to minimize downtime and cost
- Observe all safety rules and regulations and encourage others to do same, effectively reducing work-related injuries
- Report to shift supervisor on production status, problems and deviations
- Attend project training and support project startups
- Respond to and support underperforming assets
- Communicate process changes, solutions, troubleshooting to day support teams
- Shift resource for top problem and resource identification
- Centerlining and quality audits and control
Material Flow Specialist (FDA Regulated Facility)
Kimberly-Clark
01.2006 - 10.2006
- Recorded information, shortages and discrepancies to keep records current and accurate
- Completed scheduled inventory counts and supply audits to track shrinkage and inform purchasing decisions
- Verified contents of inventory loads against Bills of Lading
- Monitored progress of tasks to provide feedback for improvement
- Supervised team to efficiently complete weekly physical inventory counts
- Assigned tasks to team members to complete within designated time frames
- Resolved conflicts between team members and addressed complaints or grievances
- Managed inventory counts for over 100 Mobile Storage trailers
Education
Some College (No Degree) - English Literature
University of South Carolina Aiken
Skills
- Leadership
- Problem solving (4SPS)
- Decision making
- OJT Trainer (T4E)
- Technical Troubleshooting
- Analytical skills
- Microsoft Word, Outlook, Publisher, Excel, Powerpoint
- Detail Oriented
- Excellent Verbal and Written Communication Skills
- Management skills
- Teamwork and Collaboration
- PASS, ETQ, SAP, IPA Requirements
Timeline
Lead Operator (FDA Regulated Facility)
Kimberly Clark Corp
01.2024 - Current
Material Flow Specialist (FDA Regulated Facility)
Kimberly-Clark
01.2006 - 10.2006
Mastery Process Operator (FDA Regulated Facility)
Kimberly-Clark
01.2001 - Current
Some College (No Degree) - English Literature
University of South Carolina Aiken
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