BRENNA SHINHOLT
Quality Assurance Specialist
Claymont,DE
Summary
Qualified Quality Assurance Specialist willing to provide support and assistance to Quality Assurance department in the oversight of quality systems. Willing to assist in Quality oversight and support the Analytics group and Operations group (Manufacturing, Stability, and Research & Development Groups) for the manufacture and testing of non-clinical and clinical products. Assisting in Quality initiatives, maintaining/improving quality infrastructure, and participating where needed on various CMC and GMP/GLP-related projects. Willing to work as a part of the Quality Assurance team to ensure compliance with the Quality Systems, supporting quality oversight at the project level and generation of metrics to drive continuous improvement while assuring the quality of materials manufactured and data generated.
Overview
8
8
years of professional experience
Work History
Quality Assurance Specialist
Clene Nanomedicine Inc.
North East, Maryland
10.2023 - Current
- Verified quality and graded finished products with visual inspections
- Completed routine and special analyses of in-process materials and finished goods
- Developed, conducted, and evaluated application audits and testing processes
- Writes GxP documentation (i.e., SOPs, reports)
- Issues production batch records and associated packaging components per the Manufacturing schedule
- Performs room clearances
- Reviews controlled documentation for good documentation practices
- Quality monitoring of in-house manufacturing operations
- Supports the disposition of raw materials, intermediates, and drug products and/or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitments
- Assists the Executive Director, Quality Assurance in developing and utilizing tools to perform risk assessment, track and report quality metrics to management for Quality Management Review
- Supports quality oversight of equipment, utility, and facility qualification activities
- Aid in implementing process improvements concerning Quality Assurance, including managing OOS procedures and related reporting
- Supports external agency and internal audits as required
- Supports the Document Control System
- Assist in the maintenance of the Document Control files (i.e., DCO Log); processes new/revised/retired documents in the current document management system.
Process Guide
Amazon
Wilmington, Delaware
06.2023 - 01.2024
- Job allocation to associates
- Monitoring and mentoring of associates on productivity, quality, and safety
- Responsible for shift quality and associated action plans
- Defining the transportation process from the fulfillment center to regular slotted cartons
- Regularly operate/use standard warehouse equipment such as pallet jacks, carts, and scanners (zebra series)
- Examine and inspect containers, materials, and products in order to ensure that packaging specifications are up to quality standards
- Remove completed or defective products or materials, placing them on moving equipment such as conveyors or in specified areas such as loading docks.
Warehouse Specialist
SafGard Safley Shoe Co.
New Castle, Delaware
09.2021 - 06.2023
- Maximized distribution and replenishment efficiency by keeping storage areas clean and organized
- Processed client orders via Amazon, FedEx, and UPS
- Completed orders, Packaging, and Shipping
- Top performer processed 450 orders averaged daily
- Scanned, Logged, and processed with in-house equipment
- Maintained product knowledge
- Prepared and verified shipping documents.
Office Manager
CNV Wholesale Autos
Wilmington, Delaware
01.2016 - 10.2019
- Controlled office supplies, including placing new orders, monitoring usage, and coordinating regular restocking
- Supervised front office activities expertly, including accounts payable and receivable, reception, and mail management
- Completed advanced clerical tasks, including account reconciliation and document management
- Processed vehicle registrations and title transfers
- Maintained updated permits and licensing
- Handled inbound phone calls from prospects/customers
- Maintain vehicle inventory, sales reports, and invoices
- Input employee payroll via OuickBooks.
Education
Diploma -
Continental Academy
05.2008
Skills
- Ability to independently analyze and solve moderate to complex issues
- Working knowledge of cGMP principles concerning appropriate regulatory practices, requirements (FDA, ICH guidelines), and standards
- Problem-solving skills, effective written and verbal communication skills
- Highly organized and able to manage multiple priorities
- Demonstrate initiative and accountability in a fast-paced environment
- Excellent documentation skills and attention to detail
- Working knowledge of MS Office Suite (Word, PowerPoint, Excel)
References
References available upon request.
Timeline
Quality Assurance Specialist
Clene Nanomedicine Inc.
10.2023 - Current
Process Guide
Amazon
06.2023 - 01.2024
Warehouse Specialist
SafGard Safley Shoe Co.
09.2021 - 06.2023
Office Manager
CNV Wholesale Autos
01.2016 - 10.2019
Diploma -
Continental Academy
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