Lishan Gracia

Passionate, problem-solver eQMS professional and 2023 QOL Medical Employee of the Year. Offers extensive experience in customer-centric and GMP-regulated environments, serving as SME in leading quality events frameworks and process optimization. Expert in document control, inspection readiness, supplier management, and training development.

Certified Quality

Auditor (CQA) and Lean Six Sigma Agent, maintaining high-quality standards through data-driven analysis and cross-functional leadership.

Quality Compliance Associate, Sr. at QOL Medical, LLC (2022-03 – 2026-05)

• Plan and lead internal and external audit meetings and follow-ups using Excel to ensure 100% audit-ready within regulatory compliance frameworks.
• Execute document effectiveness (hardcopy and electronic) for 500+ controlled documents in ZenQMS, verify saved natives and printed masters, and distribute them in a timely manner.
• Administer daily QMS dashboard in edit, extract, and redact workflows, managing document control, change controls, maintenance backup, and training effectiveness in alignment with 21 CFR Part 11.
• Scan and index daily documentation into the SharePoint repository, focusing on data integrity, site access, and adaptability in complex scenarios.
• Collaborate with management to monitor and report bi-weekly quality metrics, summarizing quality records, complaints, and QC investigations in Excel, identifying gaps.
• Manage training materials for 20+ job-based training curricula by creating courses and events, upholding quality standards, and operational best practices, resulting in zero discrepancies across production, engineering, QA/QC, and Supply Chain.
• Implemented ZenQMS and SharePoint quality management systems for 2,000+ records, enabling retrieval, archival, and on-time review and closure, supporting audit readiness.
• Facilitate annual GMP training for 50+ department employees, covering GMP, GDP, QMS best practices, product safety, and adherence with regulatory requirements.
• Serve as SME Backroom for FDA regulatory audits, in the retrieval of regulatory files, and in preparing 500+ controlled documents for agency inspectors.

Quality Assurance Associate (QA) at QOL Medical, LLC (2021-06 – 2022-03)

• Supported supplier qualification audit reports against the approved supplier list, ensuring compliance with external suppliers' quality agreements and company services.
• Released 90% of batch records on time while maintaining strict adherence to GMP policies.
• Conducted periodic Good Documentation Practices (GDP) reviews, reducing documentation errors and site-ready timelines by 95%.
• Supported quality management for 2,000+ records, leading RCA and CAPA processes to ensure on-time closure.

Digital Shopper Team Lead at Walmart Corporation (2019-04 – 2022-01)

• Led 25 team members on digital CRM tools, achieving 100% training effectiveness.
• Supported order fulfillment reporting using data insights to identify quarterly sales trends.

Sales Associate & Pricing Lead at Kmart Corporation (2015-12 – 2019-03)

• Managed 260+ online merchandise orders in SAP with accuracy in a high-volume environment.
• Analyzed pricing data and logistics, supporting store warehouse storage and inventory tracking.

Bachelor of Science in Biology (Chemistry Concentration) – Inter American University of Puerto Rico