Quality Specialist Senior Resume Sample

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Tiana Berge
684 Gleichner Villages,  Houston, TX
+1 (555) 794 7087

Work Experience

Senior Audit & Quality Specialist
02/2017 - PRESENT
Chicago, IL
  • Create, review or approve (as authorized by Quality Manager) documentation such as EWO’s, TO TDR, OTR, and OTI
  • Coordinating and/or leading projects in a matrix organization
  • Managing and tracking project deliverables using project management methodologies and tools
  • Analyzing and defining resources and skill requirements for projects
  • Working with Business, Product Owners and Customers
  • Managing Quality Assurance team members directly or indirectly through a project
  • Managing Quality Assurance testing efforts
  • Developing Quality Assurance project plans and estimates
  • Hands MSP Experience in Consumer , Mortgage – Payment Operations
Quality Assurance Senior Specialist
04/2013 - 01/2017
Detroit, MI
  • Understand the consumer , mortgage payment hierarchies (KPLO), Payment types, Investor operations & workflows
  • Strong knowledge of Quality Assurance; System Functional testing, UAT testing
  • Hands on in Test Automation tools like Selenium, UFT is added advantage
  • Knowledge and experience of auditing against ISO standards including ISO9001, ISO27001, ISO22301 or equivalent audit experience
  • Experience of writing briefings, proposals, reports and business correspondence
  • Deal with contentious and sensitive issues diplomatically
  • Excellent communication skills and the ability to deal effectively and professionally with colleagues at all levels and external agencies
Quality Assurance Specialist Senior
08/2007 - 11/2012
Detroit, MI
  • Strong educational background demonstrating excellent analytical and communication skills
  • To assist in the development and implementation of processes, policies and procedures as a result of reviews of current business practices
  • To communicate effectively, both verbally and in writing with internal and external colleagues, customers and senior managers
  • To liaise with external agencies, including Ofqual, SQA, EAB and JCQ, as required in connection with the role
  • Excellent organizations and presentation skills
  • Research, write, and edit technical material for proposals
  • Participate in proposal strategy, technical/budget design, writing, and review sessions throughout the life of the proposal


Fairleigh Dickinson University - Metropolitan Campus
2003 - 2007
Bachelor's Degree in Science

Professional Skills

  • Strong written and verbal communication skills and ability to collaborate effectively
  • Excellent verbal and written communication skills, including listening, comprehension and application of concepts
  • Strong communication skills and ability to review complex systems to identify integration points for end-to-end test scenarios/case creation
  • Strong communication skills and ability to review complex systems to identify integration points for system end-to-end test scenarios/case creation
  • Keen to use own skills and knowledge to support the wider division inachieving business objectives
  • At least five years of experience in the pharmaceutical industry with three years involving validation projects
  • Keen to use own skills and knowledge to support the wider division in achieving business objectives

How to write Quality Specialist Senior Resume

Quality Specialist Senior role is responsible for integration, auditing, microsoft, manufacturing, training, database, java, reporting, design, modeling.
To write great resume for quality specialist senior job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Quality Specialist Senior Resume

The section contact information is important in your quality specialist senior resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Quality Specialist Senior Resume

The section work experience is an essential part of your quality specialist senior resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous quality specialist senior responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality specialist senior position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Quality Specialist Senior resume experience can include:

  • Excellentcommunication skills and the ability to deal effectively and professionally withcolleagues at all levels and external agencies
  • Strong, independent decision-making skills
  • Excellent communication skills with internal and external personnel essential
  • Demonstrated ability to develop new technical skills
  • Competent computer skills including Microsoft Office
  • Knowledge andexperience of auditing against ISO standards including ISO9001, ISO27001,ISO22301 or equivalent audit experience

Education on a Quality Specialist Senior Resume

Make sure to make education a priority on your quality specialist senior resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality specialist senior experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school

These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Quality Specialist Senior Resume

When listing skills on your quality specialist senior resume, remember always to be honest about your level of ability. Include the Skills section after experience.

Present the most important skills in your resume, there's a list of typical quality specialist senior skills:

  • Strong educationalbackground demonstrating excellent analytical and communication skills
  • Experienced working in a team environment with strong communication skills
  • Previous auditing experience in addition to extensive liability claims background and strong process management skills
  • Use decision making skills to prioritize the workload during busy times
  • Excellent organisationaland planning skills
  • Strong computer skills, especially within a Microsoft Windows operating system,

List of Typical Experience For a Quality Specialist Senior Resume


Experience For Quality Assurance Senior Specialist Resume

  • Responsible for development, deployment and maintenance of effective and efficient procedures surrounding document control and records management
  • Knowledge of chemical compounding controls and aseptic processing techniques in a pharmaceutical environment
  • Develops implements and reviews Standard Operating Procedures, Work Instruction and other Quality Documentation
  • Provide support during internal and external audits related to documentation and eQMS
  • Provide support to all areas requiring Quality Assurance support

Experience For Senior Audit & Quality Specialist Resume

  • Assist groups by performing QA review of Non-Conformances, CAPA, Change Controls and other quality issues as needed
  • Contribute/review proposal outlines and compliance matrices
  • Review proposal pieces and final text for quality, clarity, and consistency responsiveness to RFP requirements, in preparation for reviews and final production
  • Travel internationally and domestically to establish relationships with the client, potential partners and/or local staff, gather operational information and country context, and analyze the competitive environment for considering RTI's differentiators
  • Ensures the maintenance of quality records, nonconformance, project outcomes, and that stakeholder input is filed in an accurate and timely manner
  • Management and Review of the change control process, tracks the approval process / action execution

Experience For Senior Technical Quality Specialist Resume

  • Contributes to the development of corrective action / preventive action plans and monitors implementation
  • Management of the nonconformance
  • Performs GAP assessment evaluation against corporate standards and support process improvement implementation
  • Execution of Internal Audits within Company, assures preparation for External Audits and Health Authorities Inspections
  • Provide Quality support in Supplier Management process, assessment of suppliers based on Quality Assurance criteria, company quality policy, standards and local regulations
  • Four to six years’ experience in quality control or quality assurance in a pharmaceutical, biopharmaceuticalor medical device manufacturing environment
  • Write and revise SOP’s as needed
  • Performs review and approval of protocols, reports, and SOP’s
  • Maintains proper control of operations’ documentation by following SOP’s, manufacturing procedures, GMPs, ISO requirements, OSHA guidelines and other pertinent regulatory requirements

Experience For Quality Assurance Specialist Senior Resume

  • Issue violation letters to shippers who deliver products that don’t meet Energy Transfer quality specifications published in most current Tariffs, Rules and Regulations
  • Knowledge of crude oil and other petroleum product characteristics, ASTM and API test methods/standards and pipeline logistics
  • Responsible for the day to day use and maintenance of the corporate records management program
  • Develop and present formal recommendations for enhancements, upgrades and business process changes related to Documentation and Quality
  • Establish and deploy timely metrics in relation to documentation to assist in Quality/Management meetings to drive for continuous improvement
  • Maintain storage and inventory of documents and records
  • Work independently and take initiative in a fast-paced work environment

Experience For Senior R&D Quality Specialist Resume

  • Plans, develops, organizes and executes validation activities applicable to area of technical expertise in accordance with GMP, Iso 9000, and applicable guidelines which includes project management, validation documentation generation, and project tracking
  • Assists in the development, organization and/or review of validation documentation and SOPs for other departments, based on assigned responsibilities and areas of expertise
  • Maintains project deadlines and communicates validation activities with appropriate personnel in a timely manner
  • Assists in the development and/or review of validation related SOPs and Forms
  • With comprehensive ability of Microsoft Word and Microsoft Excel

Experience For Senior Mortgage Quality Assurance Specialist Resume

  • Understand and apply regulatory/compliance requirements relative to their role
  • Apply knowledge of internal/external processes to identify and drive improvement opportunities
  • Work independently in an empowered culture with a minimal level of guidance and direction, while applying team effectiveness skills, listening, and integrating diverse perspectives from across the workgroup
  • Assist Communications lead with creating and deployment of site and global level communications
  • Interpret customer needs, assesses requirements and identifies solutions to non-standard requests
  • Explain difficult issues and works to build alignment around a complex situation

Experience For Quality Assurance, Senior Specialist Resume

  • Make decisions within guidelines and policies which impact a range of standard and non-standard customer, operational, project or support activities
  • Contribute and add value to the achievement of common goals for the team
  • Provide information for regulatory inspections as needed
  • Potential opportunity to support other areas within MMD West Point Quality Assurance
  • Primary responsible for developing, implementing, and maintaining technical quality assurance and control systems for the COBRA DANE program across all locations and work areas
  • Defines and specifies the implementation of standards, methods, and procedures for inspecting, testing, and evaluating work products and services
  • Oversight of all QA activities at all COBRA DANE work locations, establishes priorities and evaluates performance of QA Journeyman at the System Integration Lab and on-site radar site

Experience For Senior Crude Oil Quality Specialist Resume

  • Communicates directly with the COBRA DANE Program Manager for all quality related activities, generates applicable quality related contract deliverable documents to be delivered to the government customer
  • Assure cGMP’s and company procedures are followed and, if needed, procedures/policies are revised
  • Assist and collaborate with other department such as Manufacturing, Quality Control, Clinical Operations, Regulatory, and Pharmacovigilance to ensure continued compliance, product quality, and patient safety. Troubleshoot issues related to quality concerns, implementing effective solutions and corrective actions
  • Creates metrics for the assigned areas of responsibilities to ensure performance is monitored and actions are taken when required for continuous quality system improvements
  • Responsible for conducting financial and operational reviews by examining and verifying statistical and operational records and policy and procedures as part of the quality assurance program to measure and assess operating and compliance performance
  • Respond to internal and external inquiries, both verbally and in written form, related to departmental policies and procedures, regulatory requirement information or guidance as it relates to all operational functions
  • Ensure quality performance and operational efficiencies through the daily review of reports, SharePoint intakes, and branch/operational documentation exercising good judgment to issue exceptions appropriately for mistakes in policy, procedure, or risk based items
  • Experience in quality assurance, preferably in bank operations, and/or other risk management functions in a financial institution
  • Promoting continual improvement throughoutthe business

Experience For Senior Logistics Quality Specialist Resume

  • Training and supervision of other members ofstaff as required in relation to the audit functions
  • Prepare and maintain current, accurate, and detailed project files, meeting deliverables and track results of quality reviews performed
  • Collaborate and support or lead companywide quality planning continuous improvement projects (e.g. QSIP etc.)
  • Support North America supplier management team in identifying opportunities for improvements
  • Actions resulting from audits and reviews are completed within the agreed completion date where possible

Experience For Senior External Manufacturing Quality Specialist Resume

  • Results-driven with the ability to work independently and under minimal direct supervision
  • Basic knowledge of Microsoft suite of products - Word, Excel, Visio, SharePoint, and PowerPoint
  • Identify and implement effective quality control systems at the Medical Device/Pharma/EM supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
  • Complete Non-conformances and CAPAs related to FG/EM suppliers within required timelines
  • Proactively investigate, identify and implement best-in-class Supplier Quality practices
  • Provide technical mentorship and resolve quality supply chain issues with Valeant and FG/EM suppliers
  • Support quality disciplines, decisions, and practices across Bridgewater, NJ site

List of Typical Skills For a Quality Specialist Senior Resume


Skills For Quality Assurance Senior Specialist Resume

  • Detail oriented with proven organizational and project leadership skills
  • Proven experience in relevant areas of Quality, Regulatory or Engineering, preferably within a medical device environment
  • Confident and open personality who is able to communicate effectively, both written and orally with people at all levels
  • Strong understanding of quality responsibility while working in a regulated environment
  • Experience working in an API (active pharmaceutical ingredient) manufacturing facility
  • Experience establishing/managing quality programs on projects of similar size and complexity
  • Thorough knowledge of GMP concepts relating to a Pharmaceutical manufacturing environment and validation activities
  • Supervisory and/or team leading experience
  • Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment

Skills For Senior Audit & Quality Specialist Resume

  • Good attention todetail and accuracy when reporting of activities and analyses
  • Experience ofwriting briefings, proposals, reports and business correspondence
  • Engineering or technology experience
  • Experience managing quality programs on projects across multiple and/or remote/austere locations
  • Interpret and conceptualize manufacturing and analytical methods and processes in order to develop applicable validation protocols

Skills For Senior Technical Quality Specialist Resume

  • Proven fluency in English and other applicable languages relevant to their specific geographies
  • Hands on experience with application development and quality assurance with the ability to train and guide personnel within a global delivery model
  • Reporting ofactivities and analyses in an accurate, timely, consistent and effective mannerappropriate to the intended audience
  • Experience in a managerial role
  • Demonstrated ability to develop and mentor peers and partners

Skills For Quality Assurance Specialist Senior Resume

  • Experience with Cobra DANE radar System
  • Experience in an IT specialty function (e.g., infrastructure, Application development, or analytics)
  • Quality Risk Management experience
  • Hands on experience with CAPAs and SOP revision
  • Demonstrated self-starter with capability to develop innovative solutions to challenges and process improvements
  • Speaks with courage and candor; Strong customer service focus
  • Reports on execution and closure of corrective and preventive actions, nonconformance, strong cooperation with CAPA, NC Owners
  • Developed conceptual and practical expertise in own discipline; act as a resource for colleagues with less experience within own discipline
  • Strong attention to detail with the ability to think outside of the box for risk identification and remediation

Skills For Senior R&D Quality Specialist Resume

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with FG/EM suppliers
  • Ensure Finished Good/External Manufacturing suppliers are compliant to all regulatory (US and International) and Valeant requirements
  • Participate in quality change request management activities, corrective and preventive actions as well as effectiveness verification activities, as required
  • Working knowledge of GMPs as they pertain to pharmaceutical manufacturing
  • Branching and merging strategies for Java test case management

Skills For Senior Mortgage Quality Assurance Specialist Resume

  • Working knowledge of Application Lifecycle Management (ALM) and HP Agile Manager (AGM)
  • Working knowledge of Jenkins/CloudBees, SVN/GIT/GITLAB
  • Conducting both internal and external audits
  • Work with technical experts to prepare written material for proposals, including interviewing experts and/or reviewing and revising text prepared by experts
  • Objective driven and customer focused. Capable of producing results working unsupervised under own initiative
  • Less-than-truckload (LTL) Pricing/Rating
  • Some lifting and climbing
  • Maintain proposal writing training resources and lead, specific business development trainings; and
  • Solve a range of complex problems; take a new perspective using existing solutions

Skills For Quality Assurance, Senior Specialist Resume

  • Create training materials, organize and provide training for Elekta employees in document control
  • Follow the functional charter regarding values and goal setting
  • Responsible for conducting activities to ensure that application / system products and projects meet defined quality standards
  • Activities include: developing, conducting and evaluating application audits and testing processes; leading and / or conducting testing activities; and communicating with developers to correct system bugs
  • Review and maintenance of departmentprocedures and documentation relating to audit, as required
  • Participate in, and lead when appropriate,cross-departmental monitoring, audit and other project activity
  • Create inputs for management review process and quality planning

Skills For Senior Crude Oil Quality Specialist Resume

  • Record and manage quality issues, escalating serious events to senior management
  • Knowledge of and ability to apply appropriate processes, tools, and techniques for assuring a high level of quality in computer software products and systems
  • Quality Assurance (Front-end testing) environment
  • Comfortable with fast paced, positive environment with new releases coming out every 2 months
  • Use of VuGen/LoadRunner for performance script creation; Performance Center for scenario creation, script execution, and results reporting
  • Own quality of outcome for testing of Product Inventory
  • Complete daily tracking of activities performed in house
  • Prepare/summarize information from raw data using spreadsheets or other software for administrative reports
  • Coordinate and arrange large and/or recurring meetings, luncheons and conferences; Prepare materials necessary for meetings

Skills For Senior Logistics Quality Specialist Resume

  • Attend meetings as requested and prepare and distribute meeting minutes
  • Assist EM QA functions, supply chain and R&D organizations in sourcing new FG/EM suppliers
  • Can work efficiently under tight timelines
  • Use of SAFe Framework and Agile methodology
  • Experience with functional / non-functional testing processes (smoke, system integration, automation, regression, performance testing to ensure code functions as designed) and QDM methodologies
  • Use of VuGen for performance script creation; Performance Center for scenario creation, script execution, and results reporting
  • Mentor QA teams on quality assurance process improvements and use of best practices

Skills For Senior External Manufacturing Quality Specialist Resume

  • Automation test script design, development, execution; experience with SoapUI, Java, SQL, LeanFT, Selenium, UFT and Mobile Center. Knowledge of automation framework fundamentals
  • Excellent ability in Word, Excel and Visio
  • Test Driven Development (TDD) or REST API automation
  • Experience with creating automated test scripts using selenium, UFT, SoapUI, etc and be able to implement test automation solutions for regression, functional testing and web services/API testing
  • Ensure Pearson's compliance with internal procedures, regulatory requirements and external business standards such as ISO9001 (Quality Management), ISO27001 (Information Security) and ISO22301 (Business Continuity)
  • Assisting the Head of Audit and Quality and Audit and Quality Manager on the planning and scheduling of audit activity as part of an integrated audit programme covering Pearson UK sites and Pearson suppliers as required by senior management
  • Reporting of activities and analyses in an accurate, timely, consistent and effective manner appropriate to the intended audience
  • Provision of appropriate management information to the Head of Audit and Quality and Audit and Quality Manager as required

List of Typical Responsibilities For a Quality Specialist Senior Resume


Responsibilities For Quality Assurance Senior Specialist Resume

  • Relevant claims handling experience
  • A PhD with 0+ years of experience in a manufacturing environment
  • Supervisory and/orteam leading experience
  • Regulatory monitoring experience
  • Experience with Agile development (SCRUM methodology) required
  • Investigating customer escapes and performing problem solving analysis to prevent recurrence

Responsibilities For Senior Audit & Quality Specialist Resume

  • Developing, maintaining and ensuring compliance with quality assurance programs, policies, processes and procedures
  • Providing expertise and guidance in interpreting policies, procedures, regulatory/governmental regulations, and agency guidelines to assure compliance
  • Reporting Rolls-Royce Corporate Quality performance metrics across multiple levels of the business
  • Developing programs to ensure the performance and quality of products conforms to established standards, specifications and, agency guidelines
  • Understanding of vocational and/or general qualifications
  • Provide training for testing teams in the use of the tools to support testing activities
  • Participate with testing teams on first level forensic debugging of defects at application & system levels

Responsibilities For Senior Technical Quality Specialist Resume

  • Set up and manage test environment, testing tools, and job scheduling
  • FedEx Freight Pricing/Rating
  • An understanding of statistical process control
  • Ensure communication exists with Site of Manufacture so that all upcoming regulatory inspections and customer audits are known to Global Logistics Quality
  • Product and benefit expertise; preferably deep understanding of Cigna's products and benefits
  • Familiarity with Database Structures and data modeling

Responsibilities For Quality Assurance Specialist Senior Resume

  • Confident in making oral presentations
  • Confident inmaking oral presentations
  • Support testing activities in the test environment
  • Assist testing teams on processes & procedures
  • Assist quality management in all audits (FDA, Notified Body, other Regulatory agencies) that occur at the BW site
  • Directly support management team for activities related to Annual Product Reviews, Management Review, Complaint Review Board and Critical Action Committee
  • Assist Elekta employees in document control activities

Responsibilities For Senior R&D Quality Specialist Resume

  • Prepare monthly metrics for their area of expertise / responsibility
  • Work on projects / compliance activities to completion
  • Analyze process data and trends and drives optimization / improvement
  • Report operational issues (process or system related) to QA manager – QMS
  • Proactively suggest ideas to deliver continuous process improvement
  • Promote and maintain adhere to Elekta values
  • Circulate documentation to support QA activities
  • Identify areas for improvement and escalates through the chain of command

Responsibilities For Senior Mortgage Quality Assurance Specialist Resume

  • Support processes and procedural changes
  • Prepare reports, spreadsheets or documentation for data analysis
  • Trained to a Lead Auditor standard
  • Personal Style and Behaviour
  • Flexible in approach and able to use own initiative to develop creative solutions to problems
  • Able to deal with sensitive and contentious issues with diplomacy and integrity
  • Committed to continual improvement in all aspects of the role

Responsibilities For Quality Assurance, Senior Specialist Resume

  • Certified in Six Sigma methodology or other process quality tools
  • Anticipate and mitigate challenges
  • Manufacturing, process development or quality assurance experience in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, data analysis, project management, and quality systems
  • Proficiency in MS Office applications and related claims and business software
  • In Quality Assurance field

Responsibilities For Senior Crude Oil Quality Specialist Resume

  • Build test case scenarios and mock data
  • Demonstrated attention to detail, ability to compile and analyze information, determine benefits, and provide resolutions or recommendations for process improvement
  • Work successfully as an individual and within a team
  • Organizational agility including the ability to foster and manage positive and influential working relationships in a matrix environment and at all levels of management
  • Self-starter with strong work ethic and sense of urgency required, including successful experience in a fast-paced environment with multiple (competing) priorities
  • Knowledge of relevant laws, legal codes, government regulations and agency rules. Includes the understanding of cGMP requirements, GxP regulations and current industry practices
  • Comprehensive knowledge of quality principals and systems, audit, manufacturing processes, procedures and equipment within a pharmaceutical biologic environment

Responsibilities For Senior Logistics Quality Specialist Resume

  • Demonstrated critical problem-solving skills with ability to coordinate process improvement initiatives and quality system related projects with high level / wide scope and complexity
  • Demonstrated ability to effectively communicate information and ideas to interact effectively with peers, senior management, regulatory officials, auditors, contractors and consultants
  • Knowledge of computer software, including relevant applications such as MS Word, Excel, PowerPoint, Box, and Dropbox
  • Hold people and functions accountable for resolving product quality issues, identifying root cause, implementing corrective and preventative actions and performing effective verification activities
  • Travel to supplier sites is required
  • Maintenance of ISO22301, ISO9001 and ISO27001 certifications
  • Production of high quality audit plans that include appropriate audit scopes and objectives, and consider realistic timescales for audit completion

Responsibilities For Senior External Manufacturing Quality Specialist Resume

  • Production of high quality audit reports that are factually accurate and findings are a true representation of the process audited. Audit reports are produced within the agreed timescales
  • Audit recommendations are made that provide a benefit to the business and improve business processes
  • Measurable improvements in related business processes
  • Assisting the Head of Audit and Quality onthe planning and scheduling of audit activity (particularly at the Hellabysites) as part of an integrated audit programme covering Pearson UK sites andPearson suppliers as required by senior management
  • Completing all aspects (i.e. planning,execution and reporting) of assigned integrated audits, in accordance with BusinessImprovement and Regulation auditprocesses
  • Provision of appropriate managementinformation to the Head of Audit and Quality as required
  • Preparation of information and data for managementreview process
  • The Senior Auditor and Quality Specialist willalso support the broader work of Business Improvement and Regulation by workingacross the various functions of the division, including investigations intocases of appeal, malpractice, maladministration and breaches of security,regulatory monitoring and business continuity when required
  • The Senior Auditor and Quality Specialistwill also support the Qualifications Processing division based at Hellaby withother quality management activities when required

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