Nikki Malone
Union,KY
Summary
Quality assurance professional known for high standards and consistent results. Extensive experience in identifying and resolving quality issues to maintain top-tier product standards. Reliable team player with focus on collaboration and adapting to evolving project needs. Proficient in quality control processes and detail-oriented analysis.
Overview
14
14
years of professional experience
Work History
Quality Assurance Specialist II
SpectronRX Radiopharmaceuticals
12.2022 - Current
- Provide QA oversight for manufacturing processes involving radioactive drug products, ensuring strict compliance with current Good Manufacturing Practices (cGMP), FDA regulations, radiation safety standards, and environmental controls for ISO 5, ISO 7, and ISO 8 classified areas.
- Review and approve batch production records, deviations, OOS reports, corrective and preventive actions (CAPAs), change controls, and cleanroom performance, in both paper-based and electronic systems.
- Oversee incoming inspection and acceptance review of raw materials, components, and packaging to verify quality and conformity with specifications.
- Review and approval of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports to validate equipment and processes in radiopharmaceutical production.
- Collaborate with cross-functional teams (Manufacturing, QC, Logistics, Radiation Safety, Regulatory) to support continuous quality improvements and maintain regulatory readiness.
- Conduct internal audits and participate in regulatory inspections involving radiopharmaceutical production and handling.
- Participate in radiation safety training, monitoring, and adherence to ALARA principles to ensure personnel and environmental safety.
Quality Assurance Supervisor
Medioh
08.2021 - Current
- Supervised QA technicians across multiple ISO 13485-certified at-home medical device manufacturing facilities, ensuring consistent adherence to regulatory and quality standards.
- Directed recruitment, interviewing, and onboarding of QA personnel to maintain a competent quality workforce.
- Managed labor tracking through Kronos and integrated SAP for quality processes, materials, and traceability in compliance with ISO 13485.
- Designed and implemented risk-based sampling plans aligned with ISO 13485 requirements to ensure product conformity and process control.
- Performed ATP testing on cleaned at-home medical kits and conducted daily skid audits, supporting cleanroom and sterility protocols.
- Led incoming inspection, in-process audits, and final release verification; applied data trending to drive continuous improvement and CAPA effectiveness.
- Regularly reviewed and updated Standard Operating Procedures (SOPs) and work instructions in accordance with ISO 13485 and FDA 21 CFR Part 820.
- Developed and delivered QMS training modules, promoting staff awareness of ISO 13485 principles, GMP compliance, and audit readiness.
- Investigated and resolved non-conformances, managed customer complaints, and led CAPA activities, ensuring timely closure and regulatory documentation.
Quality Control Inspector
Flotec
05.2021 - 08.2021
- Systematically received and logged all incoming packages, ensuring accurate inventory tracking and efficient workflow integration.
- Performed detailed inspections of vendor-supplied parts for both production and engineering applications, verifying conformance to specifications.
- Closed machine jobs and generated Non-Conformance Reports (NCRs) for nonconforming products, supporting quality control and process improvement.
- Prepared comprehensive inspection reports for internal documentation and quality audits.
- Assisted in the creation and revision of engineering drawings, numbered prints, and quality documentation for individual components and assemblies.
- Supported manufacturing by sorting and deburring parts to meet production standards.
- Utilized precision measurement tools such as calipers, micrometers, dial indicators, gauges, optical comparators, and MicroVu systems for First Article Inspections (FAI) and routine quality checks.
Senior Quality Analyst
Latham Pool Products
09.2020 - 05.2021
- Conducted detailed inspections of automatic pool covers, ropes, and associated mechanical parts to ensure quality and readiness for production.
- Utilized an iPad for on-site data entry and documentation, streamlining quality assurance and reporting processes.
- Captured high-resolution photographs of each pool cover and component for internal audits, quality tracking, and client communication.
- Supported resolution of customer complaints by providing visual evidence and detailed inspection notes.
- Played a key role in the feedback loop between production, quality assurance, and customer service teams.
Quality Technician
Gilchrist & Soames
04.2016 - 09.2020
- Analytical tests and procedures on warehouse products before use based on AQL. Data entry, inventory releases, deviation reports.
- Assisted QA and engineering in creation of specs.
- Cross trained as a quality technician responsible for checking production lines for quality work off the production line, ensuring all paperwork is filled out properly and signed.
- Testing of in house product and rework.
- Utilization of various lab tools such as calipers, micrometers, colorimeter, FTIR and familiarized with GMP, and SOPs.
Associate, End Of Line Inspector, Decal
Wabash National
11.2012 - 02.2016
- Hands-on experience in manufacturing dry and refrigerated trailer units, with comprehensive knowledge of trailer assembly processes.
- Skilled in SAP for tracking production data, inventory, and workflow management.
- Perform detailed inspections of trailers, inside and out, ensuring high standards on floor welds, foam wall integrity, and overall structural quality.
- Proficient with a wide range of air and hand tools used in fabrication, assembly, and repair.
- Apply and align decals with precision, ensuring consistent branding; conduct rework as needed to maintain aesthetic and quality standards.
- Serve as backup coordinator, supporting production leadership with scheduling, task delegation, and workflow optimization.
Cashier
Kohl's
05.2014 - 08.2014
- Operated POS system and handled cash transactions accurately.
- Served as a Sales Floor Representative, assisting customers and maintaining product displays.
- Solicited customers to sign up for Kohl's charge card and email promotions.
- Ensured store cleanliness and organization to create a welcoming shopping environment.
Retail Cashier/Customer Service
Goodwill
09.2011 - 10.2012
- Maintain sales floor cleanliness and organization at all times.
- Provide excellent customer service to all potential and current customers.
- Clean and empty clothing racks and fitting rooms regularly.
- Assist with sales transactions and support team members as needed.
- Perform any additional tasks assigned to ensure smooth store operations.
Server
Steak N Shake
05.2011 - 08.2011
- Greet and serve food and beverages to customers promptly and courteously.
- Take customer orders accurately and ensure timely delivery.
- Maintain cleanliness and organization of the dining and service areas.
- Provide excellent customer service to ensure a positive dining experience.
- Handle customer inquiries and resolve any issues professionally.
- Collaborate with kitchen and bar staff to ensure smooth operations.
Education
General Studies
Southmont Jr/Sr High School
Crawfordsville 05-2011
Skills
- cGMP regulatory and compliance
- Documentation and review
- Material Quality Assurance
- Validation Oversight
- Audit and Inspection Readiness
- ISO 13485 & FDA 21 CFR Part 820 Compliance
- Cross-Facility Quality Oversight
- QMS Training & Development
- Risk-Based Sampling & Inspection
- SOP & WI Management
- Non-Conformance & CAPA Management
- Data Analysis & Continuous Improvement
Timeline
Quality Assurance Specialist II
SpectronRX Radiopharmaceuticals
12.2022 - Current
Quality Assurance Supervisor
Medioh
08.2021 - Current
Quality Control Inspector
Flotec
05.2021 - 08.2021
Senior Quality Analyst
Latham Pool Products
09.2020 - 05.2021
Quality Technician
Gilchrist & Soames
04.2016 - 09.2020
Cashier
Kohl's
05.2014 - 08.2014
Associate, End Of Line Inspector, Decal
Wabash National
11.2012 - 02.2016
Retail Cashier/Customer Service
Goodwill
09.2011 - 10.2012
Server
Steak N Shake
05.2011 - 08.2011
General Studies
Southmont Jr/Sr High School
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