Kenny Hurst
Muldraugh,KY
Summary
Dynamic quality assurance professional with extensive experience at Catalent Biologics, excelling in product inspection and compliance with cGMP standards. Proven track record in leading teams, enhancing operational efficiency, and implementing effective problem-solving strategies. Adept at maintaining meticulous documentation and driving continuous improvement initiatives to ensure high-quality outcomes.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Packaging Associate
McKesson
08.2025 - Current
- Package vaccines for children into coolers of varying sizes based on work order.
- Labeled, recorded, and inspected packaging to prepare for shipment or storage.
- Ensured ice is at correct temperature depending on type of ice used.
- Use pallet jacks to retrieve more ice from freezer trucks to keep up with production needs. Also to obtain more coolers from storage location.
- Verify hibernated product each week to ensure no temperature excursions have occurred.
- Assisted with the packaging of freezer orders when needed.
- Proved successful working within tight deadlines and a fast-paced environment.
- Learned and followed warehouse safety protocols to prevent injuries and accidents.
- Re-packaged damaged or incorrectly packaged items.
- Utilized adhesive labels and other materials to package items.
- Loaded items onto conveyor belts and pallets.
- Cleaned and maintained production area and equipment.
- Assembled boxes, cartons and containers to package items.
- Loaded and unloaded items from production line.
- Counted items to verify accuracy of orders.
- Inspected items for defects and damage.
Quality Assurance Associate
Catalent Biologics
01.2023 - 03.2024
- Released finished batch records after quality review.
- Participated in/support internal, client, regulatory and/or vendor audits to ensure internal and external operations that impact SISPQ are in compliance with regulations, procedures, and policies.
- Maintained quality systems, processes, and facilities by observing manufacturing operations and reviewing documentation for compliance and executing assigned quality tasks (e.g., pre-approving instructions).
- Provide review and approval of change request, approve materials/vendors for usage in manufacturing.
- Support quality function by overseeing GMP activities, documentation, and reports.
- Maintained neat, tidy work environment in biopharmaceutical facility.
- Helped with customer complaint investigations to improve quality and manufacturing processes.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
Secondary Inspection Room Lead
Catalent Biologics
12.2020 - 01.2023
- Oversaw teams in Automated Inspection, Semi-automated Inspection, and manual inspection rooms.
- Filled out batch record paperwork throughout process for each lot of medications.
- Collected in-process samples for client and company retention.
- Assisted in inspection operations when needed.
- Developed expertise through a combination of job-related training and considerable on-the-job experience.
- Typically acted as a lead, coordinating the work of others – but not a people manager.
- Worked autonomously within established procedures and practices.
- Provided leadership to manufacturing personnel to identify & eliminate waste, implemented standard-work, and provided problem solving & solution implementation assistance.
- Took a leadership role in the investigation of procedural deviations, SOP revisions and non-conformances, worked closely with Quality Assurance counterparts to develop and execute robust CAPAs.
- Led shift handover or acted as a shift lead in the absence of a supervisor.
Secondary Inspection Manufacturing Operator
Catalent Biologics
07.2019 - 12.2020
- Performed inspection on all manner of product (syringes, vials, and cartridges) to ensure they were ready for client and/or patient use.
- Followed SOPs and work instructions in order to correctly perform job.
- Trained in both manual inspection and semi-automatic vial inspection (SAVI).
- Trained all staff (incoming and existing) to standard on the Reject and Reconciliation process.
- Helped to further implement the use of our Manufacturing Review training in the field so as to process batch record related corrections before they left the room.
- Regularly performed In Clearances and Out Clearances, as well as weekly, monthly, and quarterly room /incubator cleanings.
- Assisted new employees in their work duties when needed.
- Proven to succeed in fast pace environment with deadlines.
Medical Device Assembler
Cook Medical
08.2017 - 04.2019
- Used GDP (Good Documentation Practices) and cGMP to record all information accurately and to perform job appropriately.
- Performed weekly cleanings each Tuesday in order to keep department clean and as close to sterile as possible.
- Trained entirely in Flexor Sheaths, also had experience working in Needles and Packaging when needed.
- Followed detailed assembly instructions, processes, and procedures.
- Verified specifications by measuring completed components.
- Maintained organized, neat workspace and removed all waste and debris to promote efficiency and optimal productivity.
Education
No Degree - Criminal Justice
Indiana University
INNo Degree - Criminal Justice
Ivy Tech Community College of Indiana
Bloomington, INHigh School Diploma -
Martinsville High School
Martinsville, IN06-2012
Skills
- Product packing
- Deadline oriented
- Label verification
- Warehouse safety
- Product inspection
- ISO standards
- Batch production records
- Six sigma methodologies
- CGMP compliance
- Defect tracking
- Yield evaluation
- Decision-making
- Documentation and reporting
- Internal audits
- Quality assurance
- Team leadership
- Problem-solving skills
Certification
- Yellow Belt in Six Sigma Lean Manufacturing
Languages
Spanish
Limited Working
Timeline
Packaging Associate
McKesson
08.2025 - Current
Quality Assurance Associate
Catalent Biologics
01.2023 - 03.2024
Secondary Inspection Room Lead
Catalent Biologics
12.2020 - 01.2023
Secondary Inspection Manufacturing Operator
Catalent Biologics
07.2019 - 12.2020
Medical Device Assembler
Cook Medical
08.2017 - 04.2019
No Degree - Criminal Justice
Indiana University
No Degree - Criminal Justice
Ivy Tech Community College of Indiana
High School Diploma -
Martinsville High School