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Quality Assurance Specialist Resume Example

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QUALITY ASSURANCE SPECIALIST
Professional Overview
Quality Assurance Professional CAREER SUMMARY Detail-oriented, conscientious Quality Assurance professional with over 16 years of experience in the biotechnology, medical device, cosmetic, and chemical industries. Solid cGMP foundation in commercial and contract manufacturing with exceptional communication and writing skills. Strong team player recognized for the ability to collaborate with diverse individuals and organizations. Highly driven with the ability to work independently and produce results.
Core Qualifications
  • Critical Thinking
  • Problem Solving
  • Review with Accuracy
  • Time Management
Accomplishments

Implemented new work process flow which increase department productivity.


Education
Bachelors of Science:University of Rhode Island - Microbiology ChemistryKingston, RI
Experience
Quality Assurance Specialist01/2013 － 01/2014Guthy/ RenkerSanta Monica, CA
  • Executed operational activities within the Quality Assurance function.
  • Knowledge and experience across a wide range of QA functions (reviewing and approving manufacturing master records, product specifications and SOPs, deviation investigations, product dispositions, audit programs, annual product reviews, and also contract service provider oversight and issue resolution).
  • Responsible for assigned activities to ensure internal compliance, including customer complaint investigations, training, trending and metrics development, and other GMP activities.
  • Verified marketed products met internal and external requirements as all work must be accomplished in accordance with GMP requirements.
  • Performed customer complaint investigations.
  • Reviewed specifications, procedures, and related documentation as assigned.
  • Collected, trended and published QKPIs and reports, escalating issues to management.
  • Performed annual product reviews (APR) Reviewed/approved Certificates of Analysis and Certificates of Manufacture and batch releases.
  • Collated Annual Product Review data and provided summaries for CSP manufactured products.
Quality Compliance Specialist01/2012 － 01/2013Bausch + LombRancho Cucamonga, CA
  • Responsible for oversight of document/change control management systems and timely execution of NC/CAPA systems.
  • Provided support of local product manufacturing labeling processes.
  • Prepared and managed internal and external audits and inspections.
  • Established training plans and requirements within the site.
  • Executed various Quality/Compliance metrics such as NC/CAPA, product complaint evaluations, management review, training and yield/scrap.
  • Implemented and maintained external standards.
  • Worked closely with the Global Team to manage regulatory compliance expectations.
  • Timely management of excursions and trending.
  • Worked with site leaders to ensure timely updates on training plans and compliance to training metric.
  • Maintained the internal/supplier audit schedule.
  • Chaired the NC/CAPA board.
Quality Compliance III01/2008 － 01/2012ABBOTT LABORATORIESWorcester, MA
  • Responsible for Quality data review to ensure accuracy and completeness of analytical assays such as Size Exclusion HPLC, Cation Exchange Chromatography, Poros A HPLC, Hydrophobic Interaction Chromatography, Reversed-phase HPLC, Weak Anion Exchange Chromatography, Ultraviolet Spectrophotometry assay (A280), UV/VIS Spectrophotometry and Gravimetric Analysis), Polyacrylamide Gel Electrophoresis, Isoelectric Focusing Gel using Novex Gel System and Colloidal Blue Staining procedure, On Stage Clotting, Enzyme Linked Immunosorbent Assay (ELISA), Capillary SDS-Gel Electrophoresis, Bradford Protein Assay, Peptide Mapping, appearance (Visual, Color, Clarity), pH and Total Organic Analysis, and Conductivity analysis used for raw materials, in-process, Bulk Drug Substance, and stability release.
  • Provided quality support of laboratory investigations, nonconformance, and deviations.
  • Trained and worked with associates implementing good documentation practices to improve accuracy, cGMP compliance, and neatness of data.
  • Prioritized and coordinated multiple manufacturing and Contract manufacturing organization (CMO) projects and data in order to meet strict and aggressive timelines and changing priorities.
  • Provided validation, raw materials, in-process, STAT samples, and stability review against specification, protocol, and batch records.
Senior Quality Assurance Associate01/2004 － 01/2007AMGEN INCGreenwich, RI
  • Responsible for providing final disposition of raw materials and components used in the manufacturing process of Bulk Drug Substance (BDS).
  • Performed inspection of cell bank receipts, sampling and inspecting of raw materials, components, kits, and vials.
  • Labeled and provided quality oversight for the shipping of BDS vessels.
  • Performed post-shipping documentation review of BDS from Contract Fill/Finish facility.
  • Provided Trackwise support for Nonconformances and Corrective/Preventative Actions (NC/CAPA) related to raw materials and components, and facilitated Logistics Quality Assurance Department (LQA) staff meetings.
  • Provided support for project activities, investigations, complaints, and other quality systems as they relate to commercial biopharmaceutical manufacturing and packaging.
  • Researched and identified non-compliance issues which resulted in improved flow of bulk drug substance process.
  • Compiled an instructional training manual to help in the preparation of monthly review for LQA department.
  • Provided quality oversight for the Amgen Rhode Island building 1 (AR1) and 5 (AR5) warehouses in providing weekend coverage.
Quality Control Analyst II01/2000 － 01/2004DOW BIOPHARMACEUTICAL CMSRI
  • Responsible for the sampling, inspection, and full USP/NF/ACS monograph testing of raw materials, components, and in-process samples under cGMP guidelines and aseptic techniques.
  • Performed routine and non-routine laboratory procedures.
  • Performed operational, calibration, troubleshooting, and maintenance of laboratory equipment such as pH meter, conductivity meter, TOC, analytical balance, UV/VIS spectrometer, FTIR, and melting point apparatus, performed wet chemistry, titrations, assays, and daily environmental monitoring of samples.
  • Conducted out of specification investigations and deviations, data review, and report generation.
  • Involved in the implementation of a safety program that met OSHA's standards for the site, complied with safety guidelines, GLP, cGMP, and CFR.
  • Selected as key participant in the establishment of a Raw Material department.
  • Trained new staff members.
Quality Assurance Analyst01/1998 － 01/2000INTERNATIONAL SPECIALTY PRODUCTS ISPAssonet, MA
  • Responsible for the testing and release of raw materials, in-process, and finished-goods.
  • Performed installation, maintenance, and troubleshooting of laboratory equipment.
  • Wrote, reviewed, maintained, and conducted training of laboratory SOPs.
  • Documented data entry results into LIMS database and organized bi-monthly safety site meetings.
  • Participated in method development utilizing HPLC to determine product purity as well as presence of impurities.
  • Demonstrated ability to conduct testing in the following techniques: wet chemistry, GC, HPLC, FTIR, UV/VIS, TLC, viscometry, KF, specific gravity, titrations, assays, moisture analyzer, melting point, density, purity determination, and pH.
Memberships/Scholarly Societies

ASQ (American Society of Quality)

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Resume Overview

Companies Worked For:

  • Guthy/ Renker
  • Bausch + Lomb
  • ABBOTT LABORATORIES
  • AMGEN INC
  • DOW BIOPHARMACEUTICAL CMS
  • INTERNATIONAL SPECIALTY PRODUCTS ISP

School Attended

  • University of Rhode Island

Job Titles Held:

  • Quality Assurance Specialist
  • Quality Compliance Specialist
  • Quality Compliance III
  • Senior Quality Assurance Associate
  • Quality Control Analyst II
  • Quality Assurance Analyst

Degrees

  • Bachelors of Science : University of Rhode Island - Microbiology Chemistry

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