Ji Lee

Ensure quality and regulatory standards are met per company goals and expectations.

Sr. Quality Assurance Manager - InvaPharm, Inc.

(2023-05)

Ensure quality and regulatory standards are met per company goals and expectations.

• Oversee, and maintain food safety standards, policies, and Quality Management Systems (QMS) in line with Food and Drug Administration (FDA) regulations, Food Safety System (FSSC 22000), ISO 9001 standards.
• Lead in continuous improvement activities throughout the organization by conducting risk-based food safety assessments, identifying hazards, and utilizing quality system expertise.
• Maintain quality assurance operational objectives by setting goals, standards and implementing policies.
• Implement quality initiatives to ensure effective reporting of quality system metrics.
• Establish training programs for the training of employees on Quality System and standards.
• Lead all third-party audits, regulatory inspections and close out audit outputs/nonconformances.
• Support in internal audits to ensure continued compliance with regulatory agencies, third-party audits, and enforce current Good Manufacturing Practices (cGMPs), Safe Quality Foods (SQFs) standards.
• Lead complaint investigations, escalation, and reporting requirements.
• Coordinate CAPA process to ensure the effective implementation of root cause analysis identified.
• Maintain annual review of Food Safety Plans, Food Defense Plans, Foreign Supplier Verification Programs (FSVP)
• Assess and maintain supplier qualification programs to ensure raw materials, components, and packaging materials are not compromised.
• Provide leadership and work effectively in a shared team environment and department goals.

Director of Quality - Baxco Pharmaceutical, Inc.

(2022-09 - 2023-05)

• Developed and implemented quality systems, quality policies & standards are maintained.
• Served as team representative in strategic planning and operating discussions with senior leadership.
• Interfaced with regulatory agencies as required, represent to authorities and inspectorate bodies.
• Supported Clinical studies and Pilot projects to coordinate regulatory submissions.
• Provided leadership in developing and directing quality assurance, improvement initiatives and supplier products to ensure ongoing compliance with local, national, and international standards and legislation.
• Ensured compliance with quality systems, quality procedures, quality policies and applicable regulatory requirements to facilitate compliance with regulatory agencies and customers' requirements.
• Analyzed industry trends and anticipates changes in the competitive or regulatory landscape to adjust plans as appropriate.
• Developed, implemented, and maintained quality procedures, quality policies, product specifications, test methods to ensure defined quality objectives are met.
• Reviewed and disposition manufacturing records, quality control data for in-process and finished products.
• Lead investigations to determine root cause(s) and appropriate corrective & preventive action (CAPA) related to manufactured products.
• Managed quality assurance including organizing and prioritizing group tasks, performing training, and writing performance reviews.
• Maintained current knowledge of applicable compliance requirements through attendance at industry and regulatory agency sponsored meetings and seminars.
• Promoted a Quality culture with appropriate responsibility and accountability at all levels and functions.

Senior Quality Assurance Manager - iHerb House Brands

(2020-01 - 2022-05)

• Oversaw quality system for iHerb House Brands.
• Developed, implemented, and maintained quality process /systems to drive continuous improvement.
• Lead regulatory compliance to domestic/ international regulations, product quality and food safety.
• Managed internal and external audits and technical reports of inspection/audit findings.
• Collaborated with Supply Chain and Product Development to assess raw materials for reformulation and/or ingredient substitutions.
• Managed iTested program and serve as QA subject matter expert for internal cGMPs operations in the resolution of out-of-specification investigations.
• Managed product registration with stakeholders and appropriate regulatory authorities in foreign countries.
• Ensured suppliers food safety plans and quality practice compliances and all relevant documentation and programs.
• Managed Vendor Qualification Programs and continuously monitor their status and maintaining performance metrics.
• Supported contract-manufacturers and Supply chain to obtain finished product specification and compliance.
• Managed product withdrawals, executed recall events and provided supporting documents.
• Established and ensured specifications for raw materials, components, works-in-progress, and finished goods align with state and federal regulations, including labeling requirements.
• Managed consumer satisfaction measures, customer reviews, document control, release and stability testing program, root cause problem solving, and new product quality assurance.

Dietary Supplement Auditor - NSF International

(2017-10 - 2020-01)

• Performed audits in dietary supplements manufacturing and warehouse facilities to ensure quality, regulatory, safety and NSF requirement standards are met.
• Delivered findings/results of inspections/audits with client site management or appropriate client personnel. Interpret audit guidelines and prepare final audit reports.
• Reported the completion of inspections/audits reports within assigned timeframe.

Quality Assurance Assistant Manager - Wellington Foods, Inc.

(2015-12 - 2017-10)

Assisted QA Manager in ensuring compliance with current Good Manufacturing Practices (CGMPs), Standard Operating Procedures (SOPs), and regulatory requirements.

• Managed internal and external audits and technical reports of inspection/audit findings.
• Collaborated with Supply Chain and Product Development to assess raw materials for reformulation and/or ingredient substitutions.
• Managed iTested program and serve as QA subject matter expert for internal cGMPs operations in the resolution of out-of-specification investigations.
• Managed product registration with stakeholders and appropriate regulatory authorities in foreign countries.
• Ensured suppliers food safety plans and quality practice compliances and all relevant documentation and programs.
• Managed Vendor Qualification Programs and continuously monitor their status and maintaining performance metrics.
• Supported contract-manufacturers and Supply chain to obtain finished product specification and compliance.
• Managed product withdrawals, executed recall events and provided supporting documents.
• Established and ensured specifications for raw materials, components, works-in-progress, and finished goods align with state and federal regulations, including labeling requirements.
• Managed consumer satisfaction measures, customer reviews, document control, release and stability testing program, root cause problem solving, and new product quality assurance.
• Reviewed and dispositioned batch production records and issued certificate of analysis.
• Supported in managing product hold, non-conforming products and release of products.
• Initiated investigations of out-of-specification results and act as primary company liaison to FDA and other regulatory agencies personnel in the absence of QA Manager.
• Assisted in the preparation and execution of regulatory, customer and third-party audits.
• Lead in investigating quality related customer complaints, documenting and enforcing corrective actions and preventive actions.
• Ensured updating and preparing new SOPs, Master Manufacturing Records, Hazard Analysis Critical Control Points (HACCP), and other controlled documents.
• Provided updating and preparing new specifications for raw materials, packaging components and finished products.
• Ensured QA auditors are trained on new or existing quality procedures and policies, auditing personnel for performance evaluation, implementing programs or provide cross-training.
• Supported maintain current and new raw material supplier approvals and monitoring program.
• Assisted in interviewing, hiring, training, resolving problems and mentoring QA Auditors and QA Supervisor.

Quality Assurance Supervisor - Wellington Foods, Inc.

(2012-12 - 2015-12)

Title changed due to incremental increase in responsibilities over a five-year period.

Quality Control Lab Technician - Wellington Foods, Inc.

(2011-09 - 2012-11)

• Performed analytical and sensory testing on in-coming raw materials in accordance with Standard Operating Procedures (SOPs), U.S. Pharmacopeia (USP), Food Chemicals Codex (FCC) and in-house Specifications (documents, test results, calculations, and observations).
• Performed qualitative & quantitative chemical and physical analysis of raw materials and finished goods. Prepared standards and reagents calibrate and operate instruments (pH meter, scale, refractometer, titrator, viscometer, FT-IR spectrophotometer and, etc.).
• Documented analytical data in laboratory notebook and follow Good Laboratory Practices. Order laboratory supplies, reserve samples collection and storage.

Quality Assurance Auditor - Wellington Foods, Inc.

(2010-06 - 2011-09)

• Enforced Current Good Manufacturing Practices (CGMPs) and Good Documentation Practices (GDPs) at all stages of the manufacturing process & all places within the manufacturing areas.
• Verified all raw materials and packaging components are properly received, stored and segregated (allergen vs. non-allergen, organic vs. non-organic, etc.) in the warehouse for raw materials and packaging components.
• Audited weighing/staging process, compounding/batching process to ensure that all raw materials allocated to the batch are correct and amount is correct as specified in the Ingredients Batch Records.
• Verified all quality control instruments (balances, pH, refractometers, thermometers, hygrometers, etc.) are properly calibrated. Monitored the effectiveness of cleaning and & sanitation of staging, weighing rooms, compounding/batching rooms, powder blending rooms, filler and packaging rooms and etc.

Research & Development Technician - Wellington Foods, Inc.

(2009-09 - 2010-05)

• Conducted research based on customer's request/concept, sourced out new ingredients and collected necessary documents.
• Prepared lab production samples, developed manufacturing process, batch record ingredient and batch record instructions.
• Prepared and make pilot batch instruction with Production team and train Production/Quality personnel for manufacturing process.

Manager - Sushi Ya Japanese Restaurant

(2008-08 - 2009-07)

• Took care of all aspects of business; restaurant décor, trained employees, negotiated purchase price of restaurant, handled accounting, and customer service.
• Notified escrow agent, Alcohol & Beverage Control (ABC) licensing board, and Environment Health Department.

Research & Development Intern - Bake Mark USA

(2008-01 - 2008-06)

• Assisted R&D technician and management with new formulation, developed formulation, cooking, and baking.
• Prepared sensory analysis of finished products.

Receptionist - Irvine Community Medical Center

(2003-12 - 2005-08)

Receptionist/Dental Assistance - Dr. Gilbert U. Rhee D.D.S.

(2001-10 - 2003-11)

Receptionist - Dr. Donald K. Chung M.D.

(1998-02 - 2001-08)

Bachelor of Science - Food Science - California State University, Long Beach (2008)