ANH HOANG
Westminster,CA
Summary
Professional Summary:
Detail-oriented Quality Assurance Specialist with extensive experience in coordinating CAPA, complaints, and effectiveness checks using Intelex and Master Control systems. Skilled in supporting CAPA owners, conducting investigations, evaluating risk assessments, and writing/revising SOPs. Proven track record of identifying root causes and implementing corrective/preventative actions. Currently expanding expertise in updating complaints SOPs and developing CAPA systems.
Key Skills:
Supplier qualification management
Perform Internal audits and take care of internal audit responses
Coordination and approval of CAPAs, complaints, and effectiveness checks
Root cause analysis and risk assessment
SOP writing and revisions
Complaint investigation and trending analysis
Regulatory affairs support for recalls
Overview
13
13
years of professional experience
1
1
Certification
Work History
Sr. Investigation Specialist
Fujifilm Irvine Scientific
01.2023 - Current
- Developed targeted strategies for addressing specific crime trends identified through rigorous data analysis.
- Ensured timely completion of assignments by effectively managing resources, setting deadlines, and monitoring progress.
- Improved case resolution times by streamlining investigative processes and implementing best practices.
- Identified potential areas of risk within investigations by analyzing data sets for suspicious patterns or anomalies.
- Detail-oriented Quality Assurance Specialist with extensive experience in coordinating CAPA, complaints, and effectiveness checks using Intelex, TrackWise Salesforce and Master Control systems.
- Skilled in supporting CAPA owners, conducting investigations, evaluating risk assessments, and writing/revising SOPs.
- Proven track record of identifying root causes and implementing corrective/preventative actions. Currently expanding expertise in updating complaints SOPs and developing CAPA systems.
- Coordinate with various departments for CAPA, complaint, and effectiveness check approval using Intelex and Master Control systems.
- Support CAPA owners in identification, review, and approval of final CAPAs, including establishing effectiveness checks.
- Evaluate risk assessments for customer complaints, CAPA investigations, and facility changes.
- Conduct investigations to identify root causes for CAPAs.
- Assist in trending analysis for complaints and CAPAs.
- Provide support to regulatory affairs for recalls and assist in responding to internal audit findings related to CAPAs and complaints.
Quality Specialist, Compliance System
BioDuro-Sundia (formerly known as Par Pharmaceutical)
04.2019 - 01.2023
- Compiled and summarized data for Annual Product Review (APR)
- Compiled and statistically evaluate production, packaging, analytical, deviation and compliant data to ascertain trends and complete APR
- Coordinated with other departments to obtain data for APR
- Took responsibility for review and revising for APR SOP, Approved Vendor List, Product Recalls, and Vendor Management SOPs based on current systems and practices using Master Control
- Established Quality Agreement templates with APIs/ Critical Excipient, Contract Laboratories, as well as Clients
- Prepared Questionnaires/ Surveys and followed up to have completion of Vendors/ Suppliers/Contract labs as part of external audits
- Develops annual supplier audit schedules in conjunction with site leadership and procurement
- Supported Management in administering Change Controls, complains, vendor management, and internal, and external audit systems
- Proceeded new and existing change controls by coordinating with authoring departments to ensure completeness of documentation and that change control progresses in approval flow to completion in timely manner using Trackwise Digital (Salesforce)
- Perform supplier and internal quality system audits including execute and prepare audit report on timely basis
- Responsible for activities related to internal audit, Supplier Audit, and Regulatory Agency Audit
- Responsible for tracking audit schedule, scheduling audit, executing audit, reporting, approve responses for observations and closing out audit.
- Assisted in the implementation of a continuous improvement culture, contributing to company-wide improvements in productivity and waste reduction.
- Developed comprehensive quality control documentation, standardizing procedures across all departments and promoting consistency.
Quality Associate III
Par Pharmaceutical
04.2019 - 04.2020
- Ensure that quality assurance standards are adequate
- Knowledgeable in industry and government quality regulations
- Provide support in the review, organization, and archiving of contracts manufacturing batch production records, bills of materials, line clearance forms, and supplement data
- Create, track and confirm that deviations are completed in a timely manner
- Track and confirm that Corrective Action and Preventive Action (CAPA) are on track and follow up with appropriate staff members to confirm closure of each CAPA
- Audit and review quality data according to existing documents and procedures.
Quality Assurance/ Quality Control Manager
AMF Pharma LLC
03.2017 - 04.2019
- Designed manufacturer batch records for weighing, blending, encapsulation, tableting, bottle packaging and powder filling
- Validated quality processes by establishing product specifications, raw materials and packaging items specifications
- Performed line clearance, in-process check for weighing, blending, encapsulation, tableting, packaging line, and finished product inspection
- Sampling and inspection of raw materials, packaging components, and in-process bulk during manufacturing and packaging operations
- Developed quality system and obtained cGMP, food recalls, and allergen control certificates
- Organized cGMP training for all employees
- Took charge of 3rd party accreditation and internal surveillance cGMP audits
- Issued and implemented CAPAs in setting of deviation or non-conformance
- Managed change control for SOP, production process, and batch records
- Supervised routine quality activities including creating production specifications, lab testing, and employee training
- Conducted IQ/OQ/PQ for processes and equipment
- Investigated customer complaints
- Verified all batch record
- Evaluated R&D pilot trials to validate formulas (ensuring the accuracy and precision of all product formulations) and manufacturing processes
- Optimized production process by identifying critical control points
- Accomplished quality assurance human resource objectives by recruiting, training, assigning, scheduling, coaching, counseling and disciplining employees
- Prepared quality reports, which included information on failed processes, corrective plans and recalls
- Maintained and improved product quality by collaborating with other members of management to develop new product, manufacturing and training methods
- Created SOPs for production and quality control systems
- Set specifications as Micro/ Heavy Metal for final products, incoming raw materials, and water source in facility.
Executive Assistant
Cali Insurance Agency, Inc.
03.2012 - 07.2017
- Communicated with insurance companies
- Helped clients claim accidents to health, auto, and homeowner insurance companies
- Translated Vietnamese to English
- Regularly performed data entry and document organization using computer software programs such as Microsoft Word, Microsoft Excel, and Microsoft Power Points
- Helped the supervisor complete requests and scheduled meetings with various insurance companies.
Member Services Representative
Alignment Health Care (worked contract under Agency)
12.2016 - 02.2016
- Made outbound phone calls to members
- Completed telephonic surveys and scheduled appointments for members
- Helped members translate Vietnamese to English.
Cashier and Baker
Ba le Sandwiches
10.2011 - 03.2012
- Kept track of supply chains in-stores and customer services
- Managed 'Yelp!' feedback and images
- Served customers with dedication and a positive attitude.
Education
Bachelor of Sciences - Pharmaceutical Sciences
University of California
Irvine, CA03.2016
Associate of Arts - Biology
Golden West College
Huntington Beach, CA05.2013
Certificate -
Certificate of Completion For Colorcon Formulation
Irvine, CA09.2018
Certificate - CDPH Food And Drug Branch
Allergen Control For Food Processors
San Diego05.2018
Skills
- Risk Assessment Abilities
- Critical thinking abilities
- Legal Compliance Understanding
- Project management expertise
- Technical writing proficiency
- Investigative Case Management
Certification
- CGMP
- Food recalls
- Allergen control
- Completion of Colorcon Formulation School
Additional Skills
Fluent in English and Vietnamese, MS Word, Excel and Power Point, True
Activities
- Pharmacy Volunteer, Preferred Excellent Care Home Infusion Pharmacy, 10/2015 - 12/2016, Assisted in maintaining IV room inventory and IV room compounder, Assisted in processing digital medical records, Communicated with receptionists, patients, and nurses on clinical information follow-up
- Research in Experimental Evolution; Aging; Biological Immortality; Drosophila; Human Evolution; Evolution of Sex, University of California, Irvine, CA, 09/2014 - 09/2015, Analyzed information from different sources, Wrote reports to demonstrate that flies with the genetic capacity to live longer were better able to resist stress at every adult age
- Member of Vietnamese Club, Coastline Community College, Fountain Valley, CA, 12/2010 - 05/2012, Organized the Committee of Vietnamese Holidays for students, Helped at health check-up events for homeless people, Organized community activities held at the local temples
Awards
EOPS Recognition Award in Honor, Golden West College, 2013
Timeline
Sr. Investigation Specialist
Fujifilm Irvine Scientific
01.2023 - Current
Quality Specialist, Compliance System
BioDuro-Sundia (formerly known as Par Pharmaceutical)
04.2019 - 01.2023
Quality Associate III
Par Pharmaceutical
04.2019 - 04.2020
Quality Assurance/ Quality Control Manager
AMF Pharma LLC
03.2017 - 04.2019
Member Services Representative
Alignment Health Care (worked contract under Agency)
12.2016 - 02.2016
Executive Assistant
Cali Insurance Agency, Inc.
03.2012 - 07.2017
Cashier and Baker
Ba le Sandwiches
10.2011 - 03.2012
Bachelor of Sciences - Pharmaceutical Sciences
University of California
Associate of Arts - Biology
Golden West College
Certificate -
Certificate of Completion For Colorcon Formulation
Certificate - CDPH Food And Drug Branch
Allergen Control For Food Processors
- CGMP
- Food recalls
- Allergen control
- Completion of Colorcon Formulation School
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