TRACEY BURT
Durham,NC
Summary
Dynamic and results-driven professional with over 25 years of extensive experience in manufacturing, quality assurance, and customer service. Demonstrates a strong work ethic and adaptability to new challenges, consistently delivering exceptional results. Recognized for outstanding interpersonal skills and reliability, along with a steadfast commitment to continuous improvement in fast-paced environments. Proven track record in fostering collaboration and driving efficiency to enhance overall organizational performance.
Overview
11
11
years of professional experience
Work History
Manufacturing Associate II
KBI Biopharma
Durham, NC
12.2023 - Current
- Documents activities in electronic systems in compliance with regulatory requirements, cGMPs, SOPs, and Policy Documents
- Performs general manufacturing support tasks such as staging materials, discarding waste, and moving equipment.
- Performing and maintaining routine/non-routine facility cleanings (daily, weekly, monthly)
- Handling and discarding hazardous and nonhazardous waste
- Managing training records and job-related functions via computer systems
- Ordering and stocking general supplies in manufacturing production areas
- Supporting various other tasks assigned by the supervisor or manager
- Certified Trainer for all assigned TRN of the Support Department and trains associates within the department
- Schedule, order materials, prepared, build and complete processing assemblies (PARs) for production.
- Followed safety protocols and utilized OSHA-approved PPE to foster safe working environment.
- Increased team productivity by providing ongoing training, guidance, and support to fellow associates.
Order Fulfillment Specialist
Stay Online Corp
Henderson & Creedmoor, NC
07.2021 - 12.2023
- Created and managed customer orders using the X3 system with a strong focus on accuracy and attention to customer requirements.
- Oversaw a backlog of assigned sales orders, ensuring smooth progression through the fulfillment cycle.
- Entered and managed data in SAP; generated pick tickets for specialty orders and custom products.
- Communicated order status and updates clearly to customers and internal teams.
- Processed new purchase orders and reported issues or concerns to management in a timely manner.
Quality Assurance Technician
Stay Online Corp
Henderson & Creedmoor, NC
01.2017 - 07.2021
- Conducted inspections of incoming shipments and in-process production to ensure compliance with quality and safety standards.
- Performed internal audits and spot tests using established sampling procedures.
- Collaborated with production teams and managers to maintain consistent product quality and address potential issues.
- Applied GMP practices to uphold internal and customer quality expectations.
- Played a key role in ensuring product readiness before shipment to customers.
Manufacturing Associate
Stay Online Corp
Henderson & Creedmoor, NC
04.2015 - 01.2017
- Picked, pulled, and prepared materials for work orders in the production line.
- Conducted pre-shipment testing of assembled products to ensure functionality and quality.
- Identified and corrected defects in components or finished goods during production inspections.
- Maintained open communication with team members to support efficient unit production.
- Verified that finished products met all customer specifications and quality standards.
Novartis Vaccines & Diagnostics
Holly Springs, NC
05.2014 - 12.2014
- Trained on basic processes, equipment, and serves as hands-on resource in Production
- Conducts all assigned activities in a safe and cGMP-compliant manner
- Cleaning, preparing, and sterilizing production equipment
- Executing process steps according to defined SOPs and BPRs
- Documenting activities in accordance with cGMPs
- Manual inspections of media and product-filled syringes for various defects
- Staging/preparing empty syringes to be filled; Palletizing filled syringes for the next process
Education
Internal Auditor Certificate - Six Sigma Certificate: Yellow Belt
Vance-Granville Community College
Bio Works: Process Technician Certificate - GMP & SOP Certificates
Durham Technical Community College
High School Diploma - undefined
Southern High School
Durham, NCSkills
- Experience in equipment testing and machine operation
- Certified Trainer
- Experience in inspection
- Basic knowledge of BPR/logbooks
- Aseptic Gowning
- Proficient in assembly
- Quality assurance
- Internal audits
- SAP
- Quality inspection
- Order fulfillment
- Order management system
- Experience working in a team environment while executing SOPs/cGMP practices
- Autoclave
- Reviewing Logbooks
Timeline
Manufacturing Associate II
KBI Biopharma
12.2023 - Current
Order Fulfillment Specialist
Stay Online Corp
07.2021 - 12.2023
Quality Assurance Technician
Stay Online Corp
01.2017 - 07.2021
Manufacturing Associate
Stay Online Corp
04.2015 - 01.2017
Novartis Vaccines & Diagnostics
05.2014 - 12.2014
Bio Works: Process Technician Certificate - GMP & SOP Certificates
Durham Technical Community College
High School Diploma - undefined
Southern High School
Internal Auditor Certificate - Six Sigma Certificate: Yellow Belt
Vance-Granville Community College