Quality Assurance Process Improvement

JUSTIN L. HOWELL

Lithonia, GA ********@*****.*** 864-***-****

PROFESSIONAL SUMMARY

Dynamic and detail-oriented Quality Assurance professional with over a decade of progressive leadership experience across pharmaceutical manufacturing and compliance operations. Proven expertise in implementing and managing Quality Management Systems, driving process improvement initiatives, and ensuring FDA and GMP compliance. Also, a certified fitness and nutrition professional with a strong commitment to performance optimization, discipline, and team development—combining technical precision with people-centered coaching.

CORE COMPETENCIES

Quality & Compliance Systems • Process Improvement & Documentation Control • FDA/GMP Standards • Training & Leadership Development • Data Analytics & KPI Reporting • CAPA & Deviation Management • System Administration (ZenQMS, Oracle, Power BI, Salesforce) • Performance Optimization & Coaching PROFESSIONAL EXPERIENCE

QA Document Control Specialist Fennec Pharmaceuticals 06/2023 – 05/2025

• Served as Systems Administrator for ZenQMS, overseeing change control, CAPA, and training modules.

• Led the migration of controlled documentation from SharePoint to ZenQMS, ensuring validated system

• integration.

• Developed and implemented audit-ready modules to support FDA and client inspections.

• Collaborated with SMEs to ensure procedural accuracy and training completion prior to effective dates.

• Maintained document control integrity through version management, issuance, and review workflows. QA Supervisor International Vitamin Corporation 08/2022 – 06/2023

• Created detailed training materials and SOPs for efficient batch record review and release.

• Trained 16 associates in Oracle, Power BI, and Körber Systems following system implementation.

• Streamlined QA documentation workflows, improving release turnaround time and reducing backlog.

• Developed and presented Quality Metrics dashboards for executive decision-making. Manufacturing Support Coordinator Thermo Fisher Scientific 07/2019 – 08/2022

• Designed real-time Excel-based KPI dashboards to enhance production visibility across departments.

• Investigated deviations and authored CAPAs to address and prevent recurring manufacturing issues.

• Partnered with cross-functional teams to improve production consistency and quality compliance. Quality Supervisor PL Developments 01/2013 – 07/2019

• Redesigned label room workflow, improving efficiency and accuracy in label issuance and inspection.

• Supported FDA and client audits; led internal audit programs to ensure regulatory compliance.

• Implemented in-process inspection protocols to identify and resolve quality issues pre-packaging.

• Oversaw Deviation Reports, CAPAs, Investigations, and Customer Complaints to maintain GMP standards. Founder / Certified Fitness Coach Iron Physique Fitness 2021 – Present

• Founded a fitness and wellness brand dedicated to sustainable transformation through tailored fitness and

• nutrition programs.

• Develop and coach clients through individualized strength and conditioning plans to improve physical

• performance and health outcomes.

• Integrate data-driven progress tracking and motivational accountability to ensure measurable, lasting

• results.

• Leverage leadership, training, and communication skills developed in corporate QA to build a

• client-centered, compliant, and growth-driven fitness operation. EDUCATION & CERTIFICATIONS

Associates of Applied Science – ITT Technical Institute • 12/2011 Certified Nutritionist – International Sports Sciences Association (ISSA) • 10/2025 Certified Personal Trainer – International Sports Sciences Association (ISSA) • 10/2025 CPR/AED Certified – ISSA • 10/2025

CAPA Certification – SkillPath • 02/2014

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