A Senior Quality Assurance Specialist is responsible for quality assurance audits and product integrity. A well-drafted Senior Assurance Specialist Resume indicates the following duties and responsibilities – performing quality assurance efforts on multiple application releases; monitoring and documenting testing activities; designing and developing test cases and strategies; satisfying releases deliverables, and project testing requirements; collaborating with the team to determine product changes; establishing testing feedback loop with developers and team members. Other duties include creating written documentation and procedures for application testing and debugging automate sprints, and test environment.
Skills and qualifications that can enhance success include the following – analytical mindset, a strong understanding of quality assurance and production technologies; commercial awareness, communication skills; analytical skills; and time management. Although education requirements vary based on industry, a bachelor’s degree is often needed to advance.
Summary : Seeking a career opportunity where can utilize skills and diverse experience to achieve goals that helps to improve peoples' lives in a day to day basis. Self-reliant, self-determined person capable of working under minimal supervision to achieve set milestones and objectives.
Leads team of QA lot release specialists supporting a seven days per week vaccine manufacturing schedule.
Manages and coordinates review and approval of over 500 different kinds of incoming materials (Critical Processing Aids (CPAs), Controlled Consumables, Raw Materials, Packaging Components, Printed Components) and supporting documentation to ensure compliance with cGMP, FDA-Regulations, Corporate Standards, Quality Agreements and SOPs.
Reviews vendor documents of quality (COA, COC, Sterility, etc.), evaluates data in order to disposition (release/reject) material.
Performs quality assurance and quality control inspection duties, including inspection of packaging and printed components as required to ensure the dimensional and visual integrity of the product is in accordance with all required quality specifications, standards, goals and objectives.
Properly documents all inspection results.
Understands the use of standard inspections tools including calipers, comparators, AQL ruler and sampling plans.
Reviews and approves component and label specifications for all business units in SAP packaging Solution.
Performs and processes sample management activities and follows established procedures to process samples accurately and within the required timeframe.
Populates LIMS database based on test methods, protocols/supporting documents and sample requests; and verifies data.
Experience
10+ Years
Level
Senior
Education
AAS
Jr. Senior Quality Assurance Specialist Resume
Objective : Reliable and accurate Senior Quality Assurance Specialist professional who delivers courteous service at all times. Skills & Certified Quality Auditor with extensive knowledge of auditing quality systems and manufacturing operations.
Skills : Word Processing, Microsoft Office.
Description :
Supervises team of 7 employees (1 QA specialist, 3 QA assistants, and 3 visual inspectors) to perform tasks related to QA unit such as batch record review, validation protocols review, 100% inspection, product sampling, and raw materials release.
Supervises QA assistants for sampling of raw materials and finished products.
Performs final review of batch records and the associated documents subsequent to the initial review by QA specialists.
Schedules, coordinates and oversees the 100% inspection and AQL inspection for final products.
Acts as a designee to the QA manger and assist in lot final disposition as needed.
Conducts and serves as lead coordinator for investigations and corrective and preventive action (CAPA) recommendations.
Conducts annual internal audit on manufacturing department and assist in compliance audits as required.
Oversees shipping of final products to the clients and different clinical - 2 - sites.
Develops and creates new clinical batch records based on client requirements and cGMP.
Objective : Detailed-oriented, reliable, and organized Quality Professional with a wide range of experience in a fast-paced and quality focused pharmaceutical manufacturing environment. Able to perform well individually or as part of a team. Excellent analytical and problem solving skills. Dedicated to maintaining high quality standards.
Skills : Microsoft Office, Access, Documentation, Detail Oriented, Documentation.
Description :
Implemented and maintained a quality system based on CFR (Code of Federal Regulation).
Supervised five Quality Assurance Auditors.
Prepared and reviewed of SOPs / Guidelines of Quality Assurance.
Compiled documents for drug and over the counter (OTC).
Reviewed Specifications, Standard Test Methods (STMs) of Raw Materials, FP, Stability, Packaging materials, and Test Data Sheets.
Reviewed Master Production Documents, Validation Master Documents and SAP master recipes for completeness and accuracy in accordance with standards and current GMPs.
Ensured that all changes to master production documents and master recipes have been implemented using an approved change control.
Ensured that current templates were applied where necessary.
Verified potency calculation to Master Production Documents, as required.
Experience
2-5 Years
Level
Junior
Education
Master's
Senior Quality Assurance Specialist I Resume
Objective : Senior Quality Assurance Specialist provides continuous customization, tracking, administration and health analysis for the CDM Program requirements adjudication process and all requested Atlassian Application Lifecycle Management Software Suite (ALMSS) projects
Skills : Management, Organizing.
Description :
Implemented and maintained a quality system based on CFR (Code of Federal Regulation).
Supervised five Quality Assurance Auditors.
Prepared and reviewed of SOPs / Guidelines of Quality Assurance.
Compiled documents for drug and over the counter (OTC).
Reviewed Specifications, Standard Test Methods (STMs) of Raw Materials, FP, Stability, Packaging materials, and Test Data Sheets.
Performed reviews and releases of analytical test results within 2 days of submission.
Prepared, reviewed, and revised certificate of analysis and consistently met deadlines.
Initiated Stability Protocols, Hold-time Protocols, Method transfer for production department.
Conducted reviews and releases of bulk and finished products which met deadlines 99%.
Experience
2-5 Years
Level
Junior
Education
Master's
Senior Quality Assurance Specialist II Resume
Headline : To obtain a Senior Quality Assurance Specialist position, which challenges the use of experience and skills, allowing to grow and add strength to a company.
Skills : Hands-on Microbiological Techniques And Problem Solving, Multilingual.
Description :
Oversees operation and maintenance of IBM compatible PC Pentium III running the following Applications: Windows 98, Office 2000, and Internet.
Responsible for installation and maintenance Of hardrives, modems, printers, scanners and other peripherals.
Performs daily NT Server backups.
Directs, develops, trains and evaluates, capable of leading a work force of quality assurance team leaders, conversion center specialists and indexing/queuing specialists.
Develops, plans, documents and implements specifications to ensure quality of work.
Monitors and maintains a high level of productivity in a fast paced environment.
Assists program manager in directing project life cycles by assisting with development of comprehensive project plans as well as both long- and short-range goals and milestones.
Capable of maintaining and establishing a process for evaluating software processes and associated documentation, and to determine the resources required for quality control.
Prepares weekly and monthly status reports.
Experience
5-7 Years
Level
Executive
Education
Bachelor's
Senior Quality Assurance Specialist III Resume
Summary : Dynamic Management Professional skilled at teambuilding, audits, risks, corrective actions, Quality Assurance, process improvement and document management. Proficient in Software Development Lifecycle (SDLC), CMMI, ITIL, ISO 9001 with excellent oral and written communication skills. Ability to lead company in SCAMPI A, B and C.
Skills : Windows NT, Windows Server, Windows 2000 And Windows.
Description :
Participated independently with customers and developers to define business requirements that were applied to design, development, implementation, evaluation and management of systems supporting Web-based Applications.
Responsible for unit, integration, and functional qualification testing (FQT) following the Scrum/Agile methodology.
Verified & Validated (IV&V) reviews and testing activity which included the development of test plans, procedures, and test/evaluation reports to support various stages of testing (e.g., unit, integration, system, performance, functional qualification, and acceptance) for all initial and updated increments/releases and components.
Supported and tested usability from the initial design stages through user acceptance.
Provided an updated Functional Requirement Document (FRD), Interface Control Document (ICD), System Design Document (SDD), Final Development Test Plan (TP), Development Test Analysis Reports (TAR), Test Problem Reports (TPR), and Systems Administration and Training Manuals.
Developed and maintained a requirements traceability matrix (RTM), controlled the project management plan, completed complex impact and risk analyses to guide definition of requirements, and provided expert technical assistance and advisory support for implementation of the processes.
Planned the project and established project milestones.
Managed project requirements and user expectations.
Designed and managed change management problem tracking system and facilitated discussions and decisions to work toward solutions.
Experience
7-10 Years
Level
Management
Education
Master's
Asst. Senior Quality Assurance Specialist Resume
Objective : Obtain a position where can maximize quality assurance and customer service experience to secure a role that is both challenging and rewarding.
Responsible for auditing internal and external clients, which include Freddie Mac, Fannie Mae, and Veterans Affairs (VA).
Ensures client policy and procedures are being adhered to through both data and VRM employee scorecards while also ensuring company adherence to SAS 70.
Performs Broker and Vendor performance reviews and scorecards.
Serves as a subject matter expert for conducting all new hire training while maintaining current training materials and desktop procedures.
Collaborates with sales force team to develop process to ensure asset managers adhere to both internal and external (VA, Freddie Mac, and Fannie Mae) market strategy-pricing guidelines.
Establishes guidelines resulted in timely price reductions and improved response time by sales team while providing an oversight and governance process to support decision making.
Partners with Leadership team to develop and implement quality control process and scorecards for vendor management, accounting and asset managers.
Reviews process led to improved controls and accurate data and audits.
Headline : To demonstrate continuous efforts to improve operations, decrease turnaround times, streamline work processes, and work cooperatively and jointly to provide quality seamless customer service. Core Qualifications High-proficiency using MS Office products (Word, Excel and PowerPoint). High-proficiency using Salesforce CRM. Exceptional organizational and time-management skills. Ability to prioritize multiple tasks and demands. Skilled at working both independently and within a team. High attention to detail.
Skills : Microsoft Office, Organizing.
Description :
Demonstrates a command of all Account Services practices and offer a superior level of quality assurance support to the department and team manager.
Assists the Quality Assurance team in its goal of monitoring the quality of work done by the Customer Care, Document Processing, and Account Production teams.
Reviews a percentage of all task types for quality and accuracy.
Monitors call center phone communications and provide scoring.
Provides feedback/re-training to the department when necessary.
Assists in the training of new team members and the ongoing training of existing team members.
Assists in the quarterly distribution of royalties.
Assists in quarterly pre-distribution QA activities; such as reviewing BI reports to identify error trends.
Prepares and submits weekly status reports for new team members during the training period.
Summary : Dynamic Management Professional skilled at teambuilding, audits, risks, corrective actions, Quality Assurance, process improvement and document management. Proficient in Software Development Lifecycle (SDLC), CMMI, ITIL, ISO 9001, 27001, and 20000, with excellent oral and written communication skills.
Skills : Editing, Writing, Research.
Description :
Updates and maintains the Master SOP manual with revisions or changes under the Supervision of the Quality Assurance Manager.
Prepares all revisions made to SOP's.
Worker's Compensation claims investigation.
Distributes departmental SOP manuals to respective departments and maintains appropriate documentation.
Reviews Regulatory Binders and Site Signature and Responsibility Logs.
Prepares updates and verifies medical licenses, training records and certifications for all employees.
Performs Fire Safety and Evacuation, Biomedical Waste (OSHA) and GCP training for all employees upon hire and on an annual basis.
Collects and reviews completed quality control documents by study to ensure compliance with SOP's and relevant study protocols.
Responsible for the administration of the REES Environmental Monitoring System.
Experience
7-10 Years
Level
Consultant
Education
Associates
Senior Quality Assurance Specialist Resume
Summary : Process centric, articulate and results-driven senior IT Quality Assurance Manager with proven expertise directing the design and delivery of software testing, requirements analysis, project management and system analysis techniques spanning the software development life cycle in both financial and healthcare industries.
Skills : Management, Organizing.
Description :
Promoted to drive QA service delivery and test standards following IT-QA reorganization under new executive leadership.
Worked collaboratively with executive leadership and key stakeholders to achieve alignment of QA service delivery with business needs.
Developed the QA engagement and service delivery procedures.
Defined and implemented QA standards and best practices and tools, test methods, nomenclature, and artifact templates.
Drafted regression and functional test script analysis process for automation.
Made significant contributions for the migration plan to and uplift of ALM/Quality Center, for the centralized management of IT service processes throughout the SDLC by business and IT teams, resulting in in a major IT cultural change across the organization.
Created a framework for the management of IT service processes and a Testing Center of Excellence.
Defined test metrics and designed dashboard for QA real time progress reporting out of ALM/QC with various views for executive management and across the enterprise.
Developed WebEx training for ALM/QC, incorporating customized metrics to evaluate success and optimize QA throughput.
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