Quality Control, documentation, materials, stability program

BAO-VAN T. HOANG

**** **** **. *****: 714-***-****

Garden Grove, CA 92841 Email: ******@*****.***

OBJECTIVE: To obtain a position in an organization where personal drive, high productivity and well

developed communication skills are desired.

QUALIFICATION: Work well under pressure, willingly assisting peers and superiors in a teamwork environment. Willingness to work hard to establish capability. Harmonious, articulate, diligent, responsible. Strong knowledge of cGMP. Fluent in Vietnamese.

EDUCATION: B.S., Biochemistry, University of California, Los Angeles, Spring 1997.

EXPERIENCE:

Jul 2013 – Nov 2014 SOURCE BIOSCIENCE, Santa Fe Springs, CA

Stability Operations Manager

Responsible for day to day operations providing Stability Storage to Pharma/Biotech companies and Sanger DNA Sequencing to Research Institutes

Manage and maintained stability walk-in rooms, refrigerators, freezers, photostability cabinets and DNA Lab instruments

Managed and maintained all clients’ stability samples. Ensured they are stored, pulled and returned according to clients’ protocols

Managed the inventories and usage of spare parts and all laboratory materials

Hosted agency and clients' cGMP and compliance audits

Acted as Quality Assurance interface to U.S. clients

Built and maintained client relationships with new and existing customers

Reviewed and approved validation protocols and reports for stability chambers

Created and revised relevant SOPs and ensured all activities undertaken at the facility are in compliance with relevant quality and regulatory requirements

Assisted in deviation, non-conforming, and CAPA reporting and investigation

Conducted training on cGMP for staff members

Jun 2001- Dec 2012 ISTA PHARMACEUTICALS, INC., Irvine, CA

Senior Quality Control (QC) Documentation & Material Specialist

Managed the validation, calibration and preventative maintenance (PM) program for all laboratory equipment: updated master schedules, negotiated and set up contracts with external vendors, wrote and executed validation protocols and reports for chambers and freezers, reviewed and approved validation, calibration/PM reports

Conducted failure investigations for laboratory equipment and instruments

Managed the receipt, tracking, issuance, and inventory control of laboratory chemicals and supplies, and pharmaceutical samples (raw materials, API, in-process, and final drug products)

Managed the stability program for all drug products & Active Pharmaceutical Ingredients: labeled, stored and pulled stability samples at intervals for internal and external testing, received, created, maintained, reviewed and approved stability schedules, records, and files

Negotiated and set up contracts with contract laboratories for external stability testing

Managed raw material samplings and environmental monitoring

Maintained all quality-related documentation for the QC department

Created, revised and reviewed relevant SOPs, protocols and reports

Initiated change controls

Participated in FDA inspections/audits

Jan 1998 – Jun 2001 WAKUNAGA OF AMERICA CO., LTD., Mission Viejo, CA Quality Assurance Associate

Received, inspected, and released packaging components, raw materials, in-process and finished products

Checked production and packaging lines to ensure cGMP and ISO compliance

Reviewed batch records, and issued Certificate of Analysis for finished drug products

Investigated customer complaints and returns

Conducted deviation/non-conforming investigations and CAPA

Quality Control Chemist

Performed various chemical tests, using both wet chemistry and instrumental methods, on raw materials, in-process, and finished product

Performed microbiological testing such as T.P.C, E.Coli, and Salmonella

Performed stability testing on in-process and finished products

May 1997 – Jan 1998 CYPRESS COLLEGE, Cypress, CA

Tutor, Chemistry, Math, and English as a Second Language

Provided one-to-one or group tutoring

COMPUTER SKILLS: Familiar with Window Operating Systems, internet usage, knowledge of Microsoft

Word, Excel, Access, excellent typing skills.

REFERENCES: Available upon request

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