Quality Assurance Specialist resume example with 8+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105(555) 432-1000, resumesample@example.com
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
01/2018 to CurrentQuality Assurance SpecialistWebstaurantstore | Bloomsburg, PA,
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
04/2015 to 01/2018Quality Control AnalystAbbvie, Inc | Barceloneta, PR,
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
01/2013 to 04/2015Quality Control TechnicianInternational Flavors & Fragrances | Jacksonville, FL,
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
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