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Quality Assurance Specialist Resume Example

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QUALITY ASSURANCE SPECIALIST
Professional Summary

Determined Quality Assurance Specialist with a dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills. Experience with building and maintaining CMO partnerships, product lot disposition, deviation investigations, change control, and process improvements.

Work History
Quality Assurance Specialist, 01/2018 to Current
Indigo Agriculture – Boston, MA
  • Ensure that Indigo applied microbial products meet established quality standards and expectations by performing microbial analytical procedures to characterize in-process and commercial samples
  • Perform QC release testing of all CMO produced microbial products including concentration and purity analysis
  • Prepare and review quality system documentation associated with non-conformance reports, investigations, OOS results, CAPA's, and Change Controls. Support in root-cause analysis and product impact assessment for investigations
  • Review/approve QC release testing data and perform lot disposition activities by issuing a Certificate of Analysis and updating the lot status in the QMS Supply Chain inventory
  • Conduct stability analysis on in-process and final formulations including physical attributes including viscosity, moisture, water activity, and density
  • Project owner for creating and maintaining cryopreserved cell banks for commercial microbe strains. Created 30 cell banks for priority microbes in 18 months to support commercial planting timelines
  • Collaborate on a cross-functional project with Supply Chain by maintaining cryovial records of vials sent to CMO's and linking the vial number to final product lot for traceability throughout the manufacturing process
  • Collaborated with the cross-functional project team to design, implement, and roll out a new Quality Management System (Oracle) company-wide across all departments within project timeline of 15 months
  • Serve as a system administrator for both Product Development and Quality Modules in QMS (Oracle)
  • Support stakeholders by serving as QA assessor/approver all document revisions for instructional documents as well as non-conformance reports, CAPA's, change control, and customer feedback
  • Maintain all controlled documents in the Quality Document Library (QDL) including SOPs, WI's, Forms, etc. for all R&D departments
  • Update and maintain all training records for R&D employees using SOPTracker
  • Project owner for developing product specifications for all RTU (Ready to Use) and TGAI (Technical Grade Active Ingredient) products. Collaborate with key stakeholders from Bioprocessing and Formulations to identify QC acceptance criteria for release for 50+ products in the microbial pipeline
  • Acted as a key point of contact for all QA aspects of releases by providing QA services and coordinating QA resources internally and externally
Quality Control Analyst, 04/2015 to 01/2018
Alexion Pharmaceuticals Inc. – Smithfield, RI
  • Implemented change control procedures associated with EM and critical utilities
  • Engaged in deviation investigations, CAPA's, and effectiveness evaluations
  • Executed various bioassays for In-process and finished product samples including Bioburden testing, endotoxin analysis, TOC, etc
  • Performed plate enumeration and microbial identification of organisms
  • Supported timely QC Testing for final product release to ensure the supply of product to patients
  • Directly supported commercial production campaign timelines by performing annual aseptic qualifications for manufacturing personnel
  • Analyzed, organized, and trended EM and water data for quarterly microbial trend reports for QC management
  • Supported internal and external audits
Quality Control Technician, 01/2013 to 04/2015
Alexion Pharmaceuticals Inc – Smithfield, RI
  • Performed Environmental Monitoring in cleanroom environments: ISO 5, ISO 7, ISO8, ISO 9
  • Executed Water Utility Sampling - WFI, clean steam, and pre-treatment systems
  • Performed gas sampling - viable and non-viable analysis
  • Performed routine laboratory cleaning and audit preparation
  • Responsible for general troubleshooting and routine preventive maintenance of equipment
Skills
  • Strong awareness of Current Good Manufacturing Practices (cGMP)
  • Expert knowledge of computer systems: Microsoft Office, LIMS, QMS, etc
  • Comprehension of key quality systems: Non-conformance, CAPA, Change Control, Deviation Investigations, etc
  • Possesses proficiency in reviewing and approving deviations, change controls, work orders, protocols, reports, batch records, and other GMP documents
  • Works well in a high-pressure environment
  • Critical thinking and problem solving
  • Documentation management
  • Excellent written and verbal communication skills
  • Organizational skills, ability to multi-task
  • Personnel training
  • Develop and maintain key stakeholder relations both internal and external
  • Batch record review and product lot disposition
  • CMO quality oversight
  • Internal auditing
  • Natural leader, mentor, and team player
Education
Bachelor of Science: Biology, 2012
University of Massachusetts - North Dartmouth, MA
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Resume Overview

Companies Worked For:

  • Indigo Agriculture
  • Alexion Pharmaceuticals Inc.
  • Alexion Pharmaceuticals Inc

School Attended

  • University of Massachusetts

Job Titles Held:

  • Quality Assurance Specialist
  • Quality Control Analyst
  • Quality Control Technician

Degrees

  • Bachelor of Science : Biology , 2012

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