Quality Control Assurance

Elaine M. Bandoma

**********@*****.***

**** ******** ***** · Vacaville Ca 95688 · 707-***-****

PROFFESIONAL SUMMARY

Analytical Chemist with more than 20 years of experience in equipment qualification, process improvement and method validation. Special strength in bench chemistry with emphasis in quality assurance and product quality control. Detail oriented and meticulous in writing scientific reports, quality procedures and work instruction.

More than 10 years of laboratory management experience. Proficient in all aspects of laboratory management from qualification of equipment, raw materials, and methods. Extensive knowledge of product quality control of raw materials and final products.

Adept at using laboratory equipment ranging from stand alone to software operated equipment. Proficient in all aspects of quality operation ranging from raw material testing to final product release. Manages and controls deviation, OOS, failure investigation, change control and CAPA.

Expert at multiple assays and sought after by colleagues, R&D, and production for product related assays. Troubleshoot assays and problem products, evaluates, and resolves customer complaints.

Proficient in using different media for ion exchange and size exclusion chromatography.

Solution oriented, collaborative, and innovative when faced with challenges.

Strong written, communication and presentation skills.

EDUCATION: UNIVERSITY OF PHOENIX

Master of Business Administration, May 2009

SOLANO COMMUNITY COLLEGE

Wastewater Treatment Program

ADAMSON UNIVERSITY, PHILIPPINES

Bachelor of Science in Chemical Engineering

EXPERIENCE: LGC – Petaluma Ca.

Scientist, Lead Investigator, Technical Development Group, 01/2021-August 2023

Participates in cross functional technical support team to resolve customer issues regarding oligo products.

Investigate customer complaints arising from oligo failure. Evaluate failure modes and determine root cause of failures.

Design experiments to determine complex assay problems related to customer’s oligo design and amplification performance. Analyze data generated from mass spectrometry and HPLC (empower software).

Troubleshoot assays that can be resolved with customers.

Document results and generate reports arising from oligo failure or customer error.

Communicate findings arising from investigation and log reports and documents in ETQ.

Generates CAPA for failure trends, and monitors completion.

Monitor customer complaint trends across all oligo design and manage the complaint issues to meet KPI requirements.

Coordinates with technical support team to ensure positive customer experience with LGC products.

BIO-RAD LABORATORIES, Hercules, Ca.

Quality Control Manager/Scientist, 11/2000-01/2021

Led a team of 6 Chemist and direct staff in daily lab operations and QC activities involving safety, assay planning, and customer demand and requirements.

Engaged team in continuous improvement within department and QC assays. Encouraged efficiency and lean practice in work environment. Qualified multiple methods that reduced assay and product lead time.

Reviewed customer complaints, Quality Notifications, exception reports and manufacturing deviations against existing process/methods and historical trends. Managed quality related CAPA and took appropriate actions to prevent recurrence.

Facilitated failure batch investigation, quality issues and make recommendations for product and process controls to mitigate quality risk.

Initiated quality holds, stopped shipment of raw materials not meeting quality specifications. Stopped production process for materials failing release specifications.

Facilitated and prepared meeting reports with Senior management, R&D and Marketing regarding Quality issues and customer complaints

Proficient at performing chromatography and column packing for size exclusion and ion exchange.

Performed various qualitative and quantitative analyses on various products using various laboratory instruments (Autotitrator, Horiba and Elzone particle size analyzer, GC, HPLC, FTIR, microplate reader (ELISA), electrophoresis instruments, UV-VIS, LPLC etc.)

Reviewed batch records and batch travelers

Eliminated ergonomic issue arising from repetitive titration by validating a method transfer using Metrohm Autotitrator.

Saved batches from failure by performing trend analysis to determine the failure mode

Authored multiple validation and qualification projects involving vendor, method, and instruments. Writes standard operating procedures and work instructions.

SUPERGEN PHARMACEUTICAL CORP., Pleasanton, Ca.

Associate Scientist, 11/1999-10/2000

Performed stability experiments on released and in-house products using USP methods

Participated in writing SOP and method validation.

Performed qualitative and quantitative test for ongoing and developing project using various laboratory instruments

Organized and executed work according to SOP and GMP/GLP method.

FLEISCHMANN’S YEAST, Oakland, Ca.

QC Analyst, 12/1997-11/1999

Developed procedures in Fleishograph, which ties with customer’s need.

Introduced control charts to monitor operator’s efficiency.

Performed routine and non-routine laboratory analyses on product, raw materials, water, and environmental samples to determine product quality control and consistency.

Performed routine process control and packaging integrity following established methods and regulatory guidelines of GMP.

Isolated and identified contaminating organisms using prescribed microbiological methods, including media preparation and plate counting to ensure proper and timely controls on product.

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