TRACEY BROWN
Raleigh
Summary
Dynamic Raw Material Specialist with a proven track record at Humacyte, Inc., ensuring 90% on-time release of raw materials. Demonstrates exceptional attention to detail and leadership in managing quality compliance and documentation. Skilled in GMP practices and adept at multitasking, driving efficiency in high-pressure environments.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Raw Material Specialist – Lead
Humacyte, Inc.
Morrisville
05.2021 - Current
- Oversee the inspection, sampling, and GMP-compliant release of raw materials used in manufacturing. Average monthly lot volume of 50+ per month with an ontime release rate of 90%
- Coordinate ordering and scheduling of raw materials testing with internal Quality Control (QC) as well as third party contract laboratories.
- Review and verify Certificates of Analysis (COAs), Certificates Of Compliances (COCs) and other required documentation for material release.
- Ensure all raw materials meet USP/EP specifications and internal quality standards prior to release for manufacturing.
- Work closely with Quality Assurance (QA) to maintain material status in ERP/WoW systems, including quarantine, approved and rejected inventory.
- Support deviation investigations, Change Controls, CAPAs related to raw material quality issues.
- Maintain accurate and audit-ready records in alignment with FDA 21 CFR Part 11 and GMP documentation requirements.
- Created and standardized over 100 specifications.
Lead Supplier Quality Assurance, Inspection and Release
BioMerieux, Inc.
Durham
06.2015 - 05.2019
- Performed specified AQL sampling and analysis.
- Ensured sampling and inspections were completed in a timely manner.
- Identified and documented nonconformances and SCARs. Managed 20+ SCARs, 20+ Non-Conformances.
- Maintained and updated status in SAP, handled 50 SAP and LIMS transactions per week.
- Released product from LIMS and maintained logbooks.
- Worked closely with Microbiology, Biochemistry, and Environmental Labs to ensure proper handling and testing of products.
Quality Control Technician II
Becton Dickinson (BD)
Creedmoor
04.2013 - 06.2015
- Worked with testing methodologies including CMM machines, pin gauges, calipers, and micrometers.
- Visually inspected molded medical parts used in IV infusions to ensure compliance and standards.
- Accountable for correct review of Device History Records (DHR).
Manufacturing Technician/Inspector/QA
Polyzen, Inc.
Apex
09.1999 - 02.2013
- Documented production by completing forms, reports, logs, and records of equipment and batches.
- Maintained a safe and clean work environment by following current good manufacturing practices (cGMP.
- Used test methodologies which included moisture analyzers, weights, scales, viscometers, and pin gauges.
- 7+ years dealing with dip molding and coating technologies including stents, wires, and instruments.
- Recommended operational changes to ensure lines were running at the most efficient capacity.
- Trained new employees and ensured all employees had the proper training required to do their jobs.
- Allocated tasks and resources.
- Accomplished manufacturing results by monitoring steps of processes, monitoring personnel and resources, and developing work standards.
- Spent significant time monitoring to ensure the safety of employees.
- Ensured that the flow of production activities was continuous and devoid of errors.
- Conducted audits for labs, including calibrations, training, paperwork, and SOPs.
- Performed final inspections on all manufactured products to ensure customers received a quality product.
- Conducted batch record reviews for medical device products and batches manufactured.
Education
Associates -
Strayer University
Garner09.2013
Skills
- Ability to Work Under Pressure
- Adaptability
- Ability to Multitask
- Leadership and Teamwork
- Attention to Detail
Certification
- BioWorks Certificate, Wake Technical Community College
- ASQ member
- GDP/cGMP refresher
- Leadership Training
Instruments
- CMM
- Calipers
- Micrometers
- Pin gauges
- Viscometers
- Moisture analyzers
Selected Achievements
- Cut Incoming material release turnaround from 5 days to 3 days by streamlining specification templates and COA review.
- Implemented AQL sampling plan that reduced incoming defects by 20% within 6 months.
- Closed 10 Supplier SCARs with 100% completion, improved supplier OTD to 85%.
- Processed 50 lots/monthly with a 90% first pass release rate.
Systems
- SAP
- LIMS
- WoW
- MasterControl
- Livelink
- TrackWise
Timeline
Raw Material Specialist – Lead
Humacyte, Inc.
05.2021 - Current
Lead Supplier Quality Assurance, Inspection and Release
BioMerieux, Inc.
06.2015 - 05.2019
Quality Control Technician II
Becton Dickinson (BD)
04.2013 - 06.2015
Manufacturing Technician/Inspector/QA
Polyzen, Inc.
09.1999 - 02.2013
Associates -
Strayer University