Quality Assurance Professional Resume Sample
Llewellyn Hand
23269 Bashirian Spurs,
Houston,
TX
+1 (555) 705 3742
Work Experience
Senior Pharmacovigilance Quality Assurance Professional
04/2018
-
PRESENT
Detroit, MI
- Closely work with developers, business analyst, production support and other groups interfacing with the product
- Maintain and create test environment for other groups within company
- Track and Report bugs using bug tracking tool
- Automate test cases using in house tools
- Backend testing experience of trading applications required in equities space. The experience can be either manual or automated
- Write, Maintain and Execute Test Scripts
- Experience working on QA experience with Jira or similar
Quality Assurance Professional
05/2011
-
03/2018
Philadelphia, PA
- Experience working with Microsoft Test Manager and Visual Studio Team Foundation Server
- Be passionate about providing lab quality support for state-of-the-art implantable medical devices
- Cooperate with business representative and IT management to specify and agree on the scope of testing
- Ensure test requirements are reviewed, clear and testable
- Create and maintain test cases and test scenarios
- Gather and manage test data
- Support during User Acceptance Testing
- Quality Engineering - Coordinates quality decisions between different quality and engineering groups. Participates in the development or modification of validation packages; design plans; and risk management deliverables (e.g. FMEAs). Team member helping and interfacing with suppliers to deliver product meeting our quality requirements
- Developing quality reports to support assessments of quality-system effectiveness
Technical Quality Assurance Professional
02/2005
-
03/2011
Chicago, IL
- Directly supporting New Product Development of innovative products
- Providing subject matter expertise in the design control process
- Performing compliance audits and interfacing with external manufacturers and/or suppliers
- Supporting and influencing manufacturing and functional teams in efforts to prevent and correct quality issues during all phases of a product’s life cycle
- Proactively manage findings, responses and CAPAs arising from audits in the Audit Database, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management
- Participate in the development of the risk based PV audit program through evaluation of elements of the UCB clinical safety and Pharmacovigilance quality system and their effect on the overall state of compliance of the system
- Lead the preparation, hosting and follow up of Regulatory Authorities inspections related to clinical safety and Pharmacovigilance activities at the Central sites, and lead or assist at Affiliate inspections as deemed necessary and practicable
Education
Doane University - Crete Campus
1999 - 2004
Bachelor's Degree in Computer Science
Professional Skills
- Demonstrated excellent communication skills, verbal and written
- Strong Analytic skills to help with solving issues, reviewing/explaining defects, updating/reviewing documents, and planning
- Effective presentation skills with experience speaking to large teams
- Strong IT skills - MS Word, Excel & PowerPoint literate
- Excellent communication skills with internal teams, customers and suppliers
- Proven good oral and written communication skills
- Excellent oral and written communication skills with a high attention to detail
How to write Quality Assurance Professional Resume
Quality Assurance Professional role is responsible for database, languages, events, credit, training, integration, auditing, trading, java, equities.
To write great resume for quality assurance professional job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Assurance Professional Resume
The section contact information is important in your quality assurance professional 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
- Telephone number
Work Experience in Your Quality Assurance Professional Resume
The section work experience is an essential part of your quality assurance professional 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 assurance professional 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 assurance professional position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Assurance Professional resume experience can include:
- Through active participation on the PV Quality Council and through direct interaction with colleagues, escalate concerns and provide expert guidance on PV compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures
- Contribute data and feedback to Patient Safety, the Affiliate Network, and other functional groups relating to Key Quality/Performance Indicators and quality compliance status
- Manage external auditors as required, ensuring that findings from internal audits are distributed, and responses and CAPAs are tracked and followed up as necessary in the Audit Database
- Fluent in written and spoken English. Additional language skills would be an advantage
- Ensuring QMS training is conducted and effective
- Training others on quality system requirements and good documentation practices
Education on a Quality Assurance Professional Resume
Make sure to make education a priority on your quality assurance professional resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality assurance professional 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 Assurance Professional Resume
When listing skills on your quality assurance professional 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 assurance professional skills:
- Demonstrated experience in successful partnership with other functional areas (Business, Engineering, Manufacturing)
- Client/server and/or distributed testing skills, knowledge of protocols, database file structures and exposure to both on-line and batch based systems
- Experience in Internal Auditing with appropriate practical experience
- Effectively network and interact with a broad range of associates spanning varied disciplines and responsibilities
- Demonstrated experience driving quality process alignment
- Quality Assurance related experience supporting combination product medical devices or similar experience in the pharmaceutical industry
List of Typical Experience For a Quality Assurance Professional Resume
1
Experience For Technical Quality Assurance, Professional Resume
- Championing, improving, and administering quality processes to ensure effectiveness
- Ensuring effective organizational understanding of QMS structure, practices, roles, and impact
- Training and educating others on quality-system M&C, procedural and software requirements and good documentation practices to help ensure compliance
- Enhancing M&C quality systems (including software implementation and validation)
- Training others on quality-system requirements and good documentation practices to help ensure compliance
- Developing quality reports and metrics to support assessments of quality system effectiveness and product line goals and objectives
- Play an active role as Business QA in validation of computerized systems supporting UCB’s Pharmacovigilance System
- High level of personal integrity with a strong commitment to patient welfare and ethical behavior
2
Experience For Wealth Management Compliance Testing Quality Assurance Professional Resume
- Establishing, maintaining, and monitoring key process indicators (KPI’s) to ensure the company is meeting quality objects and strategic planning goals
- Advising various teams (e.g., sterilization, packaging, document control, maintenance and calibration, environmental monitoring and control, etc.)
- Supporting manufacturing teams in the resolution of issues and in driving improvements
- Understanding and using product and process metrics to support decision making
- Providing coordination and support for customer complaint investigations, nonconforming material investigations and corrective and preventive actions
- Interfacing with customer quality representatives and responding to customers with updates until issue closure
3
Experience For Technical Quality Assurance Professional Resume
- Identifying and managing actions to mitigate risks that exceed defined risk acceptance criteria
- Leading cross functional teams where required, setting targets and deliverables
- Understanding and aligning actions to the global quality strategy
- Helping manufacturing with daily issues related to quality-system requirements
- Leading audit readiness for final product processing areas
- Participating in and performing quality system compliance audits
- Partnering with other associates and facilities on projects to improve procedures, processes, and the quality system
4
Experience For IT Quality Assurance Professional Resume
- Ensuring constant audit readiness for product line and assist in audit preparation and coordination to deliver successful audit results
- Influencing teams on quality behaviors and interpretations
- Interacting with suppliers to ensure a robust supply of materials and services
- Co-operating with quality associates from other plants on issues or project work, and participating in some global teams
- Experience in leading full range of Pharmacovigilance audits for internal processes/units and external partners or vendors, and in managing/hosting regulatory inspections or third party audits with depth of understanding of the theory and practice of quality management
- In depth knowledge and understanding of Pharmacovigilance systems in the pharmaceutical industry and of applicable regulations, computerized system validation, GVP principles, and practice. Able to apply theoretical knowledge in practical situations
- Demonstrated self-starter, highly reliable, with positive, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility
- Confident presenter and communicator, able to give presentations to interdepartmental audiences and represent company with external inspectors, and deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients
5
Experience For Senior Pharmacovigilance Quality Assurance Professional Resume
- Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management during audit process
- Supporting the maintenance and improvement of the Quality Management System
- Leading customer, internal and external audits
- Championing well defined quality improvement projects to support continuous improvement of systems, processes, and products related to operations
- Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
6
Experience For Ccar / Basel Quality Assurance Professional Resume
- Preparation of project QA deliverables and providing assistance to project’s staff in preparation of various procedural documents
- Work with various teams on forming integration, development and implementations requirements
- Test real-time and batch code integrated with other core banking systems. Regression test integration code to ensure functionality, stability and performance
- Drive and lead improvements in Quality Assurance & SHE resulting in improved supplier / customer satisfaction
- Supports quality of materials, manufacturing, and products in a GMP environment
- Able to travel nationally and internationally as business necessitates, up to 30% of time on average
- Forecasting projects’ QA resources needs and coordinating with the Manager, Quality Assurance Candu Projects to ensure that QA personnel are assigned to various projects and have the knowledge and qualifications required for the scope of work
- Review of QA requirements for Procurement; assessment of Subcontractors’ QA Programs, and QA contribution to selected aspects of Procurement, like review of EQR’s, etc.
- Develop & maintain the Business Management System (BMS) to cover all aspects of the company and to safeguard the company’s ISO9001 certification
7
Experience For Senior Quality Assurance Professional Resume
- Provide Quality support and approval of NCR’s, CAPA’s and Change Controls
- Assist with the development of and understands the success criteria for the integration of the various features that needs to be available for the product
- Assist with the development of and understands the success criteria for client consumption of the product
- Assist in the creation of the plan/timeline to test code integration and product configuration required for each client
- Drive client testing of code/implementation configurations, acceptance of the solution, production readiness and go-live activities with the client as well as internal Fiserv teams
8
Experience For Quality Assurance Professional Markets Manager Resume
- Create the turnover documentation to enable Implementations and Client Technical Support to manage the integration post go-live
- Dealing with incoming goods quality and communicating directly with suppliers on Gore’s specifications and standards and working with suppliers for the satisfactory resolution of nonconformances
- Contributing to or driving internal review meetings, presenting data, making recommendations and taking commitments
- Facilitating root cause analysis and corrective action identification through the use of quality problem solving tools (e.g., 5 Whys, 8D, Ishikawa Diagram)
- Identifying appropriate critical metrics, extracts and presents metric data
- Liaise and engage with other functions at all levels within the company, and with Customers & Suppliers on matters of Quality Assurance & SHE
- Produce an annual audit programme, conduct audits & assessments of the company’s BMS in accordance with the plan, write and distribute audit reports, and manage non-conformance actions
- Represent the company at supplier and customer meetings / premises
- Support the development and winning of new business as part of the company's strategy to grow its footprint both in KSA and abroad. Contributing to strategic decisions regarding new markets, capability and staff development etc
9
Experience For Project Quality Assurance Professional With French Resume
- Assess Suppliers, including on-site audit activities. Project manage the transfer in of new Suppliers and facilitate their attaining of Approved Supplier status
- Be an agent of change to develop the business, its people and its processes to meet the future company direction in regard to Quality Assurance & SHE
- Providing hands-on coordination and support for nonconforming product (NCR) investigations and corrective and preventive actions (CAPAs) from initiation to completion to ensure systematic issues are addressed in a timely manner
- Evaluates analytical data and releases Zoetis bulk and finished products that conform to corporate, customer, and regulatory specifications
- Conducts and reviews deviation investigations related to the manufacturing, packaging, testing of product, sterility assurance, and all other GMP functions. Provides guidance and oversight in identifying root cause and preventative/corrective actions
- Evaluates and approves changes to manufacturing and packaging equipment and processes, testing, IT systems and other GMP documents and programs. This includes change control that is internal to Kalamazoo, as well as regulatory or market-driven changes
- Good communication skills to deal with all levels of customers, both internal and external
10
Experience For Clinical Quality Assurance Professional Resume
- Demonstrated ability to pay close attention to detail and accuracy
- Train associates supporting the Analytical Testing Labs on Quality System requirements and Good Documentation Practices
- Review protocols and reports for validations/requalification activities in support of the Analytical Testing Labs
- Support and help prioritize activities involved with both Quality System and lab operational improvements
- Develop quality reports to support assessments of Quality System effectiveness within the Analytical Services Team labs
- Providing direct support to the Maintenance and Calibration (M&C) function and activities
- Participates in internal GMP audits and supports customer and regulatory audits
List of Typical Skills For a Quality Assurance Professional Resume
1
Skills For Technical Quality Assurance, Professional Resume
- Language skills: Fluency in English and at least one of CEE languages (e.g. Polish, Russian,...)
- Experience analyzing and solving issues, reviewing/explaining defects, updating/reviewing documents, and planning
- Experience on testing activities in a scrum environment, writing and executing test cases, and raising and tracking defect
- Experience supporting sterilization, packaging, and labeling
- Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in Pharmacovigilance-related areas
- Experience designing or developing Quality System procedures
- Thorough understanding and demonstrated use of problem-solving and quality improvement tools and techniques
- Experience testing with multiple browsers and using the associated development tools
- Experience working in a software testing lifecycle environment
2
Skills For Wealth Management Compliance Testing Quality Assurance Professional Resume
- Detailed understanding of the ISO 9001 standard with auditing experience
- Prioritize and multi-task, setting and meeting timelines
- Experience supporting or working within a pharmaceutical or medical device quality system environment
- Experience supporting an aseptic manufacturing environment is highly desired
- Experience in executing load tests using dedicated tools (e.g. Visual Studio, Load Runner, JMeter or similar)
- Relevant client facing experience and supported by numbers/achievements
3
Skills For Technical Quality Assurance Professional Resume
- Logical approach in assessing effectiveness of corrective actions
- Experience working with endovascular and catheter-based technologies
- Experience of working within a multi-functional environment
- At least three years of experience in a quality assurance role having direct responsibility for all QMS activities
- Experience working in an AS9100 quality system
- Qualified in Engineering, Quality Assurance or Business Assurance with 6 years’ experience of quality management systems and regulatory frameworks
4
Skills For IT Quality Assurance Professional Resume
- Experience in software testing
- Quality Assurance related experience supporting combination product medical devices or in the pharmaceutical industry
- Demonstrated working knowledge of FDA medical device or pharmaceutical quality system regulations and ISO medical device or pharmaceutical industry standards
- Experience working with cardiac, vascular or catheter-based technologies
- Experience working with Microsoft Test Manager (MTM) and Visual Studio Team Foundation Server. (TFS 2015 UP)
- Experience working with Microsoft SQL Server 2008 or greater
- Experience working with external clients on a periodic basis
- Experience with textiles and/or textile manufacturing
- Experience with technical aspects of laboratory work such as testing, sample, and solution preparation
5
Skills For Senior Pharmacovigilance Quality Assurance Professional Resume
- Demonstrated working knowledge of FDA quality system regulations
- Zero to five years of QA/QC experience in a GMP Pharmaceutical manufacturing environment are desired
- Three to five years of QA/QC experience in a GMP Pharmaceutical manufacturing environment are desired
- Experience in IT Service industry
- Understanding of multi-tiered architectures, networking and relational databases
- Understanding of basic software testing concepts such as Black Box, White Box, Regression, Negative and Boundary
- Be energized by working in a world-class manufacturing facility collaborating on cross-functional teams
6
Skills For Ccar / Basel Quality Assurance Professional Resume
- Test electronic trading applications which support equities, options and futures
- Write, maintain and execute test plan for new functionality/bug fixes as well maintaining the automation suite
- Basic knowledge on Visual Studio and programming languages
- Basic knowledge on Visual Studio and programming languages (at least to easily navigate through the automation code)
- Competency with various applications, to include database, spreadsheet, word processing, presentation and electronic mail
7
Skills For Senior Quality Assurance Professional Resume
- Be passionate about providing quality assurance support for a world-class manufacturer
- Experience in managing large sales teams across multiple countries/geographies. Ideally, have in-depth experience in people management and a proven record of driving teams to target attainment
- Second line management experiences
- Domain expertise in Risk Analytics, Enterprise Credit Risk, Market Risk, Credit Risk and/or Corporate Treasury
- Responsible for quality standards and procedures, quality assessment of SDLC artifacts; software test planning (customer), software testing, test cycle management
8
Skills For Quality Assurance Professional Markets Manager Resume
- Design, implementation, and measurement of quality techniques and standards related to the quality of and adherence to conformity of products and services. Participate in the Functional and UI design process as required, providing guidance and consultancy to team members and project stakeholders
- Present information effectively in communications with peers and management regarding team progress, roadblocks and general feedback. Work successfully in a team environment and demonstrate a willingness to help team members in achieving their project assignments
- Experience working and collaborating effectively in a team environment
- Demonstrate strong support for our unique culture
- Demonstrated ability to initiate, prioritize, and drive projects to completion
9
Skills For Project Quality Assurance Professional With French Resume
- Provide strong functional leadership to teams in our non-hierarchical structure
- Development experience in; Python, VB, Java, C++, Perl/Shell
- Experience in the fields of Safety, Health & Environmental (SHE) Management
- Experience in the development of assurance systems
- Experience within the Internal Audit, External Audit or Compliance Exam related fields
10
Skills For Clinical Quality Assurance Professional Resume
- Experience in a Quality Assurance role in the medical-device, pharmaceutical, or biotech industry
- Quality Assurance experience in a medical-device, pharmaceutical, biotech or other regulated industry
- Quality Assurance related experience in a medical-device, pharmaceutical, biotech or other regulated industry
- Strong knowledge of ERP and PLM systems
- + 3 years of experience as a QA
- Experience working with Kendo UI for ASP.NET or similar Web UI frameworks
- Experience in the software quality assurance industry
- At least two years experience in supplier interactions (audits, issue resolution, etc.)
List of Typical Responsibilities For a Quality Assurance Professional Resume
1
Responsibilities For Technical Quality Assurance, Professional Resume
- Experience working with ASP.NET web applications
- Experience supporting audits
- Experience in CAPA, Customer Complaints and Document Control systems
- Experience in a quality assurance role in the medical device or pharmaceutical industries
- Strong knowledge of PLM systems
- Quality Assurance experience in a medical device, pharmaceutical, biotech or other regulated industry
- Experience in a quality assurance role in the medical devices or in the pharmaceutical industry
- M&C experience in a medical device or pharmaceutical industry role
2
Responsibilities For Wealth Management Compliance Testing Quality Assurance Professional Resume
- Strong knowledge of M&C calibration software system (such as Blue Mountain Regulatory Asset Management (BM-RAM))
- Experience with test automation tools (e.g. HP QTP / UFT, MS Visual Studio, SOAtest, Fitnesse, Selenium, JMeter)
- Good knowledge of XML, HTML
- Coordinate and support Analytical Testing lab trending reviews as needed in support of Quality System requirements
- Conduct, support, and/or drive investigations as needed for lab quality events within the Analytical Testing Labs
- Partner and guide manufacturing and quality teams to establish and maintain system documentation in compliance with lab quality requirements
- Independently provide Real Time Quality impact assessments and decisions (24/7) on Drug Product issues as needed
- Supporting the day to day manufacturing process including problem solving, CAPA and nonconformance investigations and respond with appropriate risk based decision making
- Working and communicating with the QA and cross functional teams as well as non-QA organizations across the product line and MPD to support a quick and robust decision-making process in support of quality system requirements
3
Responsibilities For Technical Quality Assurance Professional Resume
- Advising, collaborating with, and influencing cross functional teams (e.g. Manufacturing, Engineering, Operations, Environmental Monitoring, Maintenance and Calibration, Regulatory, Document Control, etc.)
- Leading facility efforts to address product issues by providing direction to the implementation of effective corrective actions and monitoring the results of post-implementation effectiveness
- Supporting external certifications, audits, and standards
- Specific Functional Responsibilities Include
- Support CTE Certification specific to CardValet (API) , WebServices - Instant Issue, WebServices (Excludes Instant Issue leveraging the following applications: Client Central CTE, mConsole, INTEL ESG and WebFastest Simulator
- Respond to all client, vendor and account manager requests (email, voice mails) within one business day
4
Responsibilities For IT Quality Assurance Professional Resume
- Ensure Plan View is updated weekly
- Ensure Work Day is accurate and reflects all R&R time taken to date
- Update SIMBBA on a daily bases
- Partnering with the Analytical Services Team to ensure that testing support, documentation, test methods, and procedures are validated and in compliance with the GORE MPD Quality System
- Serve as the QA champion for the Analytical Services Team and as the QA Audit Coordinator for all audit activity
- Provide hands-on coordination and investigation within Analytical Services Team labs of failure investigations from initiation to completion to ensure time-sensitive activities, documentation and approvals are completed
5
Responsibilities For Senior Pharmacovigilance Quality Assurance Professional Resume
- Work and communicate within and outside of MPD QA organizations to support a quick and robust decision-making process in support of Quality System requirements
- Cross-train and provide back-up support to other Lab Support Quality Assurance Associates in support of Business needs
- Driving and providing hands-on coordination and support of corrective and preventive actions (CAPA), nonconforming product (NCR) and Notice of Activity (NOA) processes related to M&C
- Driving and supporting continuous improvement M&C activities based on monitored and measured data, audit results, prioritized projects, operational feedback and other inputs
- Working and communicating with QA, M&C, technical and other roles across MPD to support a quick and robust decision-making process in support of quality system requirements
- Advising and working with various teams (e.g. M&C, product line manufacturing teams, engineering, raw materials inspection, environmental monitoring and control, etc.)
6
Responsibilities For Ccar / Basel Quality Assurance Professional Resume
- Assure the application of BT’s standard processes
- Basic knowledge on Web services and REST services
- Sound knowledge of FDA medical-device quality system regulations and ISO medical-device industry standards
- Work independently, as well as part of a diverse team
- Set and meet aggressive timelines
7
Responsibilities For Senior Quality Assurance Professional Resume
- ISO 13485 Lead Auditor Certification
- ISTQB or related certification
- Microsoft Certified Professional MCSA Web Applications
- Proficiency with the Microsoft Office Suite (Outlook, Word, Excel, Power Point) and with various browsers
- Basic computer literacy (MS Word, Excel, PowerPoint)
8
Responsibilities For Quality Assurance Professional Markets Manager Resume
- Work independently as well as be a highly collaborative part of diverse teams
- Willingness to travel: 10 to 15%
- Knowledge of test methods and standards related to textiles (Color Fastness, Shade, Tear Strength, etc...)
- Demonstrated working knowledge of FDA medical device quality system regulations, ISO medical device industry standards and ISO 10012, Measurement Management Systems
- Knowledge of the application of Life Cycle Management
- Innate ability to summarize findings, discussions and research
- Advanced ISTQB certificate
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