Quality Assurance Continuous Improvement

Objective

Seeking a position in the Regulatory Compliance, Quality Assurance and Control Field

Experience

KOROS USA Inc., Moorpark, CA

Director of Regulatory, Quality Assurance, Document Control…April 2021-Present

In charge of preparing and receiving ISO 13485.

Trained and monitored employees on non-conformity report (NCR), Corrective action and preventive action (CAPA) and deviation.

Revised S.O.P., Forms and Work Instruction according to the new ISO 13485:2016 revision and Risk control requirements.

Oversee suppliers’ qualifications and annual audits.

Oversee distributors’ qualifications and annual revenue

Prepared internal audit programs and set dates for quarterly audits.

Provided technical information on Continuous Improvement Program (CIP) on understanding.

Audit and prepare require information for risk management and analysis data

Provided technical information on Key Performance Index (KPI).

Provide information on how to minimize rework, scrap and spills to improve cash flow.

Prepared and completed ISO 13485:2016 and ISO 14971 successfully.

Developlus Inc., Corona, CA

Quality Unit (Q.C & Q.A/compliance) Manager May 2017–July 2019

In charge of master and pilot files review and approval on brochures, pamphlet, boxes, bottles, and tubes to suppliers.

In charge of testing, approving, releasing, and rejecting of the raw materials and finished products.

Trained and monitored employees on non-conformity report (NCR), Corrective action and preventive action (CAPA) and deviation.

Revised S.O.P, Forms and Work Instruction according to the new ISO 9001:2015 revision and 22716 requirements.

Oversee suppliers’ qualifications and annual audits.

Prepared internal audit programs and set dates for quarterly audits.

Provided technical information on Continuous Improvement Program (CIP) on understanding.

Provided technical information on Key Performance Index (KPI).

Provide information on how to minimize rework, scrap and spills to improve cash flow.

Prepared and completed ISO 9001:2015 and ISO 22716 successfully.

Sunrider International, Torrance, CA

Quality Unit (Q.C & Q.A/compliance) Manager March 2014–April 2017

In charge of global inspection responses to Regulatory Agencies.

Trained and monitored employees for an ongoing production (Dietary Supplement, Herbal Supplement, Cosmetic and Pharmaceutical cosmetic) department audits and inspections.

Revised S.O.P according to the FDA and Korean FDA requirements.

Oversee suppliers’ qualification and annual audits.

In charge of master and pilot files review and approval on brochures, pamphlet, boxes, bottles and tubes to suppliers.

CAPA preparation, investigation and closing.

Provided technical and strategic support on regulatory compliance, quality assurance and control to various departments.

In charge of customer complaint investigation and response.

Review and approve product labels according to the country’s requirements.

Implemented training courses on GMP, CAPA and S.O.P.

Prepared annual budget for the Quality (compliance, assurance, and control) department.

Validated yield range for the herbal supplements’ masterbatch.

Prepared all production equipment IQ, OQ, PQ documents.

Part of evaluation team for Vendor’s qualifications and annual review.

Performed annual employee evaluations.

Prepared cleaning validation per department.

Prepared actual batch record yield range.

In charge of domestic and international customer complaint investigation and response.

In charge of international and domestic micro and analytical specification and label regulation requirements.

P.S.S. World Medical, Inc. Jacksonville, Florida

Regulatory Compliance, Q.A and Q.C Consultant June 2011–March 2014

Responsible for companywide quality management system and products review (Pharmaceutical, supplement, and medical food) review and update.

Reviewed and updated validation documents, documents change request, deviation, and CAPA.

Part of the evaluation team for employees, vendors, and customers’ annual review.

P.S.S./Dispensing Solutions, Inc. (DSI) Santa Ana, California

Director of Regulatory Compliance, Q. A, Q.C Oct 2008 – May 2011

Acted as the primary contact and company representative in all FDA, DEA, CDC, VAWD, subpoena and other regulatory audits. Maintained ongoing expertise in all applicable new or revised FDA/DEA State and other regulations applicable to the business of DSI. Maintained all state dispensing guideline documents.

Promoted pain management, controlled substance monitoring and patient safety programs.

Revised and updated the company S.O.P documents to maintain an ongoing compliance with all applicable regulations.

Responsible for managing all product (Pharmaceutical, supplement, and medical food) recalls, Documents Change Request, Deviation, and CAPA control programs, and all required cleaning and equipment validations and calibration programs.

In charge of suppliers and new customer’s (physicians) application approval and site audit evaluation (control substances customers).

In charge of master and pilot files review and approval on brochures, pamphlet, boxes, bottles, and tubes to suppliers.

Prepared equipment verification, protocol, annual cleaning validation, procedures and master equipment list.

Oversee submission of 2657 (Drug Product Listing) forms to the FDA, including the conversion to the new electronic 2656 (Registration of Drug Establishment/ Labeler Code Assignment) and 2657 process. Oversee all products Master Batch records.

Trained supervisors on new S.O.P, cGMP and document control methodologies to ensure an improved quality system.

Prepared a set point protocol for compliance and quality assurance team on monitoring operation and customer service department logs on a routine basis.

Responsible for all FDA, DEA, and VAWD and individual state Licensing, certifications and permits.

Biomed/Bioma2000, Irvine, California

Director of Compliance, QA and QC May 2002 –Feb 2008

Provided direction regarding FDA regulation on exporting Pharmaceutical, Functional Cosmetic, and Nutraceutical products overseas.

Directed and supported product development in accordance with (IAW) FDA regulations.

Provided information on products approvals and necessary documentations to international regulatory agencies for In vitro diagnostic products and devices

Prepared and received export and free sale certificates.

Provided strategic support and direction on regulatory affairs issues.

Reviewed and updated validation documents.

Evaluated and finalized products for stability testing, packaging and labeling IAW FDA and overseas.

Provided technical assistance, and direction to different departments.

Consulted cross-functional teams on business decisions with quality assurance and quality control implications.

BENEV Company, Inc., Lake Forest, California

Director of Compliance, QA and QC Jan 1999-Feb 2002

Established pharmaceutical, functional cosmetic and dietary supplement manufacturer.

Received drug, cosmetic and dietary manufacture license from FDA.

Prepared and received trademark registrations for needed products.

Provided strategic support and direction on regulatory compliance issues.

Managed and prepared documents for ANDA (abbreviated new drug applications) for topical hair solutions to China’s department of health and services.

Prepared medical device documentations (510K class I) for clinical chemistry, one step and serology products testing to regulatory agencies of KFDA of Korea, MHW of Japan and China’s department of health and services.

Prepared and received free sale and export certificates for China, Japan, and Korea.

In charge of master and pilot files review and approval on brochures, pamphlet, boxes, bottles, and tubes to suppliers.

Completed the proper documentation for In vitro diagnostic devices and its product lines according to KFDA, Japan, and China’s department of health and services.

Completed the proper documentation for cosmetic according to the MHW (Ministry of Health and Welfare) in Japan, KFDA in Korea and China’s department of health and services.

Evaluated and finalized Pharmaceutical, functional cosmetic and dietary supplement documents and labels.

Audited operational department documents according to the regulatory agencies’ guidelines.

Performed annual employees’ evaluations.

3M, CDI, Inc., Irvine, California

Associate Auditor and project manager …. Dec 1997-Dec 1998

Responsible for monitoring and investigating device exemption documents. Auditing heart monitor documentation according to design control of quality system regulations.

Responsible for analyzing data and maintaining records of device analysis.

Reviewed and updated validation documents, documents change request, deviation, and CAPA. Reviewed and updated compliances documents, records and Protocols for quality audit inspections.

Beckman Instruments, Inc., Brea, California

Quality Assurance and System Validation June 1996-Dec 1997

Reviewed, evaluated, and tested protocols (for diagnostic instruments and reagents, serology and one step products).

In charge of system validation, troubleshooting, prepare functional and integral testing and data analysis according to the FDA guidelines.

Reviewed and updated validation documents, documents change request, deviation, and CAPA.

Prepared medical device documents (510K class I) for clinical chemistry and toxicology devices.

In charge of testing protocols and record keeping data for software validation, troubleshooting and implementation of automated system. Maintained and supported diagnostic instruments documents and records.

California State University of Fullerton, Fullerton, California

Physical Chemistry Laboratory Assistant (part time) 1993-1996

Assisted Professor with protein diffraction preparation.

Trained students on different application of computational chemistry. Gathered data and analyzed different types of protein for protein diffraction and maintained documents and records.

Drug Aid Lab, Carson, California

Regulatory Compliance and Document Control Associate 1986-1993

Oversaw contact and communication with European and Asian regulatory agencies for exporting over-the-counter drugs.

Prepared and completed the free sale and export certificates for over-the-counter drugs

Prepared and maintained regulatory compliance documents.

In charge of Customer Complaint and Return response.

Education:

University of Phoenix, California

MBA/TM (Technical Management) 2000-2002

California State University of Fullerton, California

B.S. in Biochemistry 1993-1997

Profile

Proficient in MS Word, Excel, PowerPoint, Access, Publisher, Project Management, Database Management, Visio, Microsoft Dynamics, Concept draw Office (develop, organize, measure, and manage project).

Bilingual (English, Farsi)

Professional who is experienced in both pharmaceutical science and business environments.

Excellent communication and people skills.

Other Certifications, Memberships and Representation:

Certified Designated Representative for Florida (License# 8811336).

Certified Health and Safety Tech, State of California.

Certified Medical Assistant, State of California.

Certified ICMAD/FDA 2002 regulation.

Certificate of Participant in DEA Pharmaceutical.

Certificate of Auditing Suppliers and Contractors.

Certificate of The Rules and Regulations of Workplace Safety and Cal/OSHA Compliance.

Certificate of Project Management.

Certificate of CAPA specialist.

Certificate of ISO 9001:2015.

Certificate of Quality Management System Audits.

Certificate of SAP. (System Applications and Products)

Certificate of HACCP. (Hazard Analysis and Critical Control Point)

Member of O.C.R.A. (Orange County Regulatory Affairs) Discussion Group.

Member of A.A.C.C. (American Association of Clinical Chemistry)

Member of CLMA (Clinical Laboratory Management Association)

Member of S.C.C. (Society of Cosmetic Chemist)

Member of ICMD/FDA.

Designated Representative for:

oState of Florida

oState of Wyoming

oState of Idaho

oState of Oregon

oState of Arizona

oState of Wisconsin

oState of Texas

References:

ANDA: abbreviated new drug applications

CAPA: corrective action and preventive action

CDC: Center of Disease control

cGMP: current good manufacturing practice

CSOS: Controlled Substance Ordering System

DEA: Drug Enforcement Registration

FDA: Food and Drug Administration

ICMAD: Independent Cosmetic Manufacturers and Distributors

RA: Regulatory Affair

R & D: Research and Development

S.O.P: Standard Operating Procedure

VAWD: Verified Accredited Wholesale Distributor

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