Quality Assurance Professional Resume Samples

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A O'Keefe

Antonetta

O'Keefe

4795 Omari Ville

Dallas

+1 (555) 399 7612

4795 Omari Ville

Dallas

Phone

p +1 (555) 399 7612

Experience Experience

New York, NY

Quality Assurance Professional

New York, NY

Nienow-Grant

New York, NY

Quality Assurance Professional

Establishing, maintaining, and monitoring key process indicators (KPI’s) to ensure the company is meeting quality objects and strategic planning goals
Training, teaching, coaching, and mentoring associates
Supporting, maintaining, and improving all facets of the Quality Management System for ISO 9001 & AS9100 (taking a process approach)
Championing QSPs (writing procedures; providing training and guidance for application)
Developing procedures and initiating change documentation in support of new and existing products
Writing defensible rationales that follow good technical writing practices (background, supporting evidence, broader justiﬁcation and a decisive conclusion)
Facilitating troubleshooting and problem solving efforts

Chicago, IL

Clinical Quality Assurance Professional

Chicago, IL

Huel-Thiel

Chicago, IL

Clinical Quality Assurance Professional

Assisting in providing compliance training to Clinical Affairs associates
Be passionate about providing clinical quality assurance support for a world-class manufacturer
Working cross-functionally in identifying and resolving technical issues
Documenting/reviewing audit observations and responses; evaluating impact and making recommendations for improvement initiatives
Assisting with the clinical vendor qualification and selection process
Providing compliance guidance and advice to the Clinical Study Teams and Functional Groups
Participating in Clinical Affairs Process Improvement initiatives

present

San Francisco, CA

Technical Quality Assurance, Professional

San Francisco, CA

Buckridge LLC

present

San Francisco, CA

Technical Quality Assurance, Professional

present

Provide input to walkthroughs of Functional and Technical specifications and assist in the process of refining work estimates
Create test strategies, test plans, and execute automated test scripts via web-based simulation tool
Work with the development personnel to determine solutions of reported issues
Manage the technical and business aspects of client testing
Conduct system evaluation to determine client workflow, document usage, and business procedures to verify proper product usage
Join a team of bright engineers and business analysts as they create Fiserv's next generation Lending Solution
Identify defects within the software and notify affected parties as well as assist in problem resolution related to testing

Education Education

Bachelor’s Degree in Computer Science

Auburn University

Bachelor’s Degree in Computer Science

Skills Skills

Knowledge of QA processes applicable to Design and other nuclear life-cycle phase and quality assurance activities
Demonstrated ability to learn new skills quickly and convey to other team members
Knowledge of QA standards applicable to nuclear industry, i.e. CSA N286 and N285 series, CSA Z299, ISO 9001, ASME NQA-1
Understands skill deficiencies and assesses risks to minimize impact on IBM and the customer, directs the implementation of solid solutions
Business unit professional mastery related to sales; strategies and objectives in leading edge or critical situations
Ability to prepare, review and accept QA Manuals/Plans, procedures, operating instructions and various product technical and QA documents and records
Understands customers' business and builds a successful partnership and maintains or improves this relationship through ongoing organizational relationships within IBM
Manages unit or leads business unit in meeting sales objectives. Develops and implements product; market and/or business strategies with executive review. Has vision of overall strategies
Auditing, self-assessment and root cause assessment skills. Knowledge and use of formal quality assurance problem analysis tools (i.e. root cause analysis) would be an asset
Accountable for business unit projects or programs

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Quality Assurance Professional Resume Examples & Samples

Achievement of TSS line of business sales performance as measured in revenue, profit and signings,
TSS sales strategy deployment in IMT of CEE, - Develops and plans business strategies to meet the required objectives
Responsibility for identifying all business opportunities within the business unit. May lead other managers
Leads sales efforts of all professionals engaged in the selling of IBM products and services within Technical Support Services (TSS) team across CEE countries
Responsibility for TSS Sales eminence and high performance culture
F2F, BP and inside sales channels management from perspective of staffing, resources performance, business controls posture, and productivity,
Collaboration with rest of TSS, GTS and with other IBM brands
Discharges the basic management responsibilities and assumes additional responsibilities as assigned
Business unit professional mastery related to sales; strategies and objectives in leading edge or critical situations
Teamwork at highest levels within business unit; function; divisions as well as relationships with customer
Plans and conducts complex negotiations reaching lasting agreements and commitments
Understands customers' business and builds a successful partnership and maintains or improves this relationship through ongoing organizational relationships within IBM
Anticipates, creates and defines innovative and visionary concepts in a strategic environment
Resolve staffing and skill issues through the timely and accurate deployment of resources
Understands skill deficiencies and assesses risks to minimize impact on IBM and the customer, directs the implementation of solid solutions
Manages unit or leads business unit in meeting sales objectives. Develops and implements product; market and/or business strategies with executive review. Has vision of overall strategies
Contribute to policy making
Recognized as a leader and expert by members of the field; related functions and multi-organizations with full responsibility to define, decide on tools, processes, priorities, skills and resources required to meet objectives
Accountable for business unit projects or programs
Polish: Fluent

Quality Assurance Professional Resume Examples & Samples

Working closely with the Software Development team to identify and resolve issues both during development and testing cycles
Developing test cases based on product requirement documents
Performing manual and automated end-to-end testing based on new and existing test scripts
Filing and resolving defects reported against the software products
Assisting with Customer Support, Customer Engineering, and Sales team issues encountered by current and prospective customers
Developing tools and processes that aid in the speed and efficiency of Quality Assurance testing efforts
Demonstrating technical proficiency, and possesses analytical and communication skills
A background in technical support or development
Experience testing and troubleshooting web and client based applications
Testing and troubleshooting skills across the previously mentioned technical domains
Experience with SQL and scripting languages such as Python a plus
Testing software and finding bugs as well as suggesting ways for product improvement
Cross team communication and documentation skills
Demonstrated ability to learn new skills quickly and convey to other team members
Flexibility of schedule to assist in product deployments during off peak hours

Quality Assurance Professional Resume Examples & Samples

You will be required to Perform Call monitoring, Ticket checks & Call Calibrations - Achieve targets
Enable the operations teams achieve & exceed client metrics
Effective Coaching & feedback to entire span of agents/ service representatives
Monitor team performance, generate reports, trends & dashboards
Take new actions within & across teams, to improve productivity and share best practices
Act as a catalyst to drive adherence to all aspects under the GDF implementation

Quality Assurance Professional Markets Manager Resume Examples & Samples

Software testing: back end, front end, workflow, batch, ETL, etc
Global Delivery
Development experience in; Python, VB, Java, C++, and Perl/Shell
Communication, influence and presence
Domain expertise in Enterprise Credit Risk, Market Risk and/or Credit Risk
Experience working with Vendors

Quality Assurance Professional Resume Examples & Samples

Schedule and Conduct End-to-End Test in QA with all the systems and users affected by the release
Knowledge of FIX protocol is required
Knowledge of Exchange or Client Connectivity is a plus
Knowledge of Smart Routing/Algorithmic Trading Engine Testing huge plus
Knowledge of Equities Market is required
Basic knowledge of UNIX/Linux commands and text editors(VI) is required

Quality Assurance Professional Resume Examples & Samples

At least 2 years experience on similar role
Project Administration
Audit & Control Procedures
Quality Assurance Methodology
Detail and process oriented
English language: fluent
At least 4 years experience on similar role

Senior Quality Assurance Professional Resume Examples & Samples

For specific site(s) assure a yearly determined value of complaints reduction and work with the local sites to assure the reduction
Provide monthly bowler data (Develop Pareto and project funnels to forecast reduction)
Assess and implement pro-active activities to predict or prevent failures from occurring
Work with R&D, Supply Chain, Ops and RAQA to identify and solve major challenges using monitoring
Develop and roll-out RA/QA training, workshops and webinars and conduct training programs
Perform QSR internal audits at site and related facilities
Performs special projects at the direction of the Director, Global Quality
Implement Engineering Change strategies for new products and changes to existing products
Provide periodic Regulatory and Quality management System (QMS) assessments for executive management
Maintain regulatory documentation as it relates to Customer Complaint Handling and Corrections
Bachelor's degree (B. A. or B.S.) in a science discipline from a four-year college or university
10 plus years Quality Systems experience in an FDA/ISO regulated environment
10 plus years of project/program lead experience
5 plus years regulatory affairs experience desired
5 plus years IVD experience desired
Experience and comprehensive understanding of Regulatory compliance in the Manufacturing or Importing/Distribution of Product globally
Experience in Product Reliability programs that effectively reduce performance issues and warranty impact
FDA, cGMP., cGDP and related audit readiness planning and implementation
Ability to comprehend scientific applications issues and solve problems effectively
Ability to interact with various people in a calm and positive manner
Ability to effectively communicate information to groups of participants at all levels of organization
Proficient in computer skills and knowledgeable in required Complaint Handling software (Master Control a plus)

IT Quality Assurance Professional Resume Examples & Samples

Create manual or automated test scripts as needed and make sure defined coding standards are followed
Execute test cases as per defined criteria and maintain test results
Ensure all defects are correctly reported, analysed, assigned or escalated when needed
Test management
Minimum 2 years of experience with software testing
Good knowledge of any scripting language (or programming language)
Basic experience with SQL
ISTQB Foundation certificate

Project Quality Assurance Professional With French Resume Examples & Samples

Governs and directs all quality resources on the project
Manage the accomplishment of the Inspection and Test plan, and Suppliers Quality Plan
Report on quality performance (Escapes, NCC) to the Head of Project Quality Assurance
Ensure Product Configuration Integrity according to the As Built Baseline
Support proper implementation of changes (Change Management)
Have a specific communication responsibility to the Head of Project Quality Assurance and Head of Quality in the site regarding Quality issues
Review together with receiving sites the Escapes and Non Conforming products
Organizational freedom and independence to resolve matters pertaining to quality or stop Production if critical requirements are not met
Assure facilitation of special tools and methods in the Quality context (e.g. PFMEA, PPS)
Review and report to the Head of Project Quality Assurance the progress and execution quality against the agreed upon requirements and acceptance criteria
Co-ordinate the identification, qualification, execution and risk exposure of Special Processes
Assure the application of BT’s standard processes
Analyse all relevant Non-Conformity Costs (NCC) within the product and drives their minimization, reporting them to the Project Manager
Re-strengthen and support a reliable root-cause analysis process within the team
Bachelor or Masters’ Degree in Engineering
Good experience in a relevant/similar role in quality or Project Management, in an industrial background
Good experience in working in a project environment
Very good customer interfacing experience and abilities
Root cause analysis knowledge is desirable
Project management experience would be beneficial
Knowledge of Quality-related methods and tools (APQP, FMEA, 8D…)
Fluent in English, intermediate in French
Spanish is highly desirable

Clinical Quality Assurance Professional Resume Examples & Samples

Be passionate about providing clinical quality assurance support for a world-class manufacturer
Participating in setting up and maintaining quality systems that are compliant with applicable clinical regulations and standards
Identifying needs and then helping to develop and implement a plan for OUS CQA support
Assessing compliance of Sponsor/Investigator/Monitor/Vendor to the protocol, ICH GCP guidelines and all applicable regulations. This includes the documentation/data that is generated, documented, and reported
Planning, scheduling, and conducting or overseeing internal and external quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analyses of clinical trials
Documenting/reviewing audit observations and responses; evaluating impact and making recommendations for improvement initiatives
Assisting with the clinical vendor qualification and selection process
Supporting Clinical Affairs in problem solving at investigational sites and contracted vendors
Providing systems compliance oversight of computer systems implemented to support clinical activities as needed
Providing compliance guidance and advice to the Clinical Study Teams and Functional Groups
Providing compliance guidance and leadership for regulated activities including the preparation and coordination of inspections/audits by regulatory authorities for clinical trials
Working cross-functionally in identifying and resolving technical issues
Keeping abreast of and interpreting current worldwide regulatory requirements; advising leadership on the possible ramifications of regulatory changes
Supporting departmental, functional, divisional and corporate quality goals and priorities
Assisting in providing compliance training to Clinical Affairs associates
Participating in Clinical Affairs Process Improvement initiatives
Actively sharing knowledge with other Quality Assurance team members to build divisional bench strength and knowledge regarding Clinical Affairs and applicable regulations
Serving as Investigator for CAPAs initiated within Clinical Affairs
Bachelor's degree in the life sciences, applicable information technology or at least 5 years of equivalent experience in the Biotech, Medical Device or Pharmaceutical industries
At least three or more years of experience in a medical device, pharmaceutical, biotech industry, or equivalent contract research organization with experience applying quality system policies and procedures with regards to clinical trials both with regions within the US and outside of the US
Experience in clinical and/or quality system compliance and auditing
Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, Lotus Notes)
Strong working knowledge of GCP's and all applicable regulations
Working knowledge of 21CFR Part 11 and application of predicate rules with respect to clinical processes and systems
Working knowledge with clinical research lifecycle, EU Directives, HIPAA, and Subject Data Protection regulations and laws
Working knowledge of clinical trial operations
Organizational skills, flexibility, and ability to multi-task
Demonstrated ability to work in a dynamic team environment
Ability to handle multiple projects and priorities with competing resources
Travel 25% as necessary to achieve business and project objectives
Experience in/with

R&D Quality Assurance Professional Resume Examples & Samples

Responsible for ensuring Quality oversight to all functions within the site R&D organization and for global projects
Responsible for establishing and maintaining the quality systems for the site. Will support the rollout of quality processes for the site, function or region
Coordinate preparation activities for regulatory authority inspections to enable inspection readiness at the site. Takes delegation for hosting inspections
Provide quality and compliance training to R&D personnel. Independently develops training presentations on GXP or compliance topics as needed, acts as a key contact for training topics
Has the depth and/or breadth of expertise and technical knowledge to be recognized as an expert in quality compliance for R&D area
Responsible for maintenance (initiation, review, renewal, etc.) of Quality Agreements with third parties for development activities
Builds relationships with business partners internal and external to R&D Quality and/or key R&D business area. Interacts with regulators, customers, and other outside stakeholders on business issues
Responsible for planning and conducting: GRP, GCP or GLP study protocol reviews, vGCP in-life and data/reports reviews/audits; site process self-inspections; and GRP, GMP, GLP or GCP qualification and oversight activities for work completed at third parties. Issues self-inspection reports, and reviews and approves responses and corrective actions. Considered an expert in at least one GXP standard area, and proficient in other GXP areas
Leads large scale projects or programs with moderate and higher risks
Independently completes release of investigational batches (drug substance/API, Drug product, vaccines), seed and cell lines, and other development materials as per Elanco R&D Quality System requirements
Responsible for the execution of the site quality assurance and compliance strategy for development through appropriate use of GCP (VICH GL9), OECD GLP, GMP, USDA and/or other relevant external standards and Elanco/Eli Lilly Quality System requirements
Provides expert quality compliance consultation to Regulatory affairs
Performs quality oversight of regulatory submission documentation for technical and clinical operations involving Site R&D operations
Establishes communication and reporting mechanism to assure adequate decisions and management attention is appropriately directed. Assures there is appropriate governance and management escalation processes for Quality within Site R&D
Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, anti-harassment, and health, safety and environment (HSE) policies
Bachelor's Degree in Pharmacy, Science, Engineering or related scientific degree
7 years experience in a regulated environment in product research and development
Demonstrated vaccine/animal health development experience, with a proven track record in R&D-related Quality Assurance
Experience with quality systems processes and training
Proven ability to operate in a business focused R&D Quality organization recognized as an expert and partner to both the R&D organization and CRO/CMO business partners
Expert knowledge in one of the following: GCP (VICH GL9), GMP or GLP compliance in one or more global regulatory requirements (USDA, CFIA, MHRA/VMD, EMA)
Expert technical knowledge in one or more of the following fields for product development: technical development, biologics manufacturing, microbiology, clinical and/or safety
Experience with quality compliance for regulatory submissions in support of veterinary health registrations
Ability to negotiate favorable outcomes while maintaining positive working relationship
Skilled in risk-assessment methodologies, and project organization
Able to interpret regulations and policies, and to communicate and respond to associated questions
Ability to define problems, collect and review data, establish facts and draw valid conclusions
Strong leadership skills. Ability to effectively work with teams
Strong analytical skills. Ability to set priorities and manage multiple tasks

Quality Assurance Professional Resume Examples & Samples

Providing training to the MPD organization to sustain consistent design control processes
Enhancing quality systems as part of continuous improvement objectives
Developing procedures and initiate change documentation in support of new and existing products
Supporting day to day manufacturing processes including problem solving, CAPA and non- conformance investigations and respond with appropriate risk based decision making
Collaborating with and influencing cross functional teams (e.g., technical, operations, regulatory, document control, maintenance and calibration, environmental monitoring and control, etc.)
At least 3 years of experience in Quality Assurance and/or Quality Engineering supporting new product development in the medical device industry
Experience integrating outsourced manufacturing into the design control process
Sound knowledge of FDA quality system regulations and ISO standards (eg. 21 CFR 820, ISO 13485, etc..)
University degree in Engineering or Science

Quality Assurance Professional Resume Examples & Samples

Be passionate about quality system processes and their continuous improvement in support of state-of-the-art implantable medical devices
Supporting the day to day manufacturing process including problem solving, CAPA and non conformance investigations and respond with appropriate risk based decision making
Support new product development and design control activities
Enhancing quality systems (including software implementation and validation)
Training, teaching, coaching, and mentoring associates
Colloborating with and influencing cross functional teams (e.g.,technical, operations, regulatory, document control, maintenance and calibration, environmental monitoring and control, etc.)
Minimum of 5 years' experience in a Quality Assurance role in the medical-device, pharmaceutical, or biotech industry
Strong knowledge of/experience with quality system implementation and maintenance
Proven track record of increasing responsibilities
Experience in Pharmaceutical or Combination Product manufacturing

Project Quality Assurance Professional Resume Examples & Samples

Review customer specifications and define quality requirements
Ensure company directives and processes are deployed and enforced within the project
Conduct project audits to monitor compliance to customer contract, to the change management and configuration management processes, etc
Support project during external audits by customer, BT Group and/or third party auditors
Define the Quality deliverables and ensuring timely delivery at the right specification/acceptance criteria
Manage the non-conforming products/services and quality related customer complaints
Support with investigation of deviations
Has the responsibility to reject or block any non-conforming deliverables, which could result in safety or quality related problems
Will be the interface with the customer regarding Quality, Safety and Environmental issues.You will also be included in the overall quality and traffic safety work as a member of the QHSE department. This includes internal audits, work in the management system, etc
Excellent understanding of concepts and procedures within Quality Assurance
Experience of Advanced Product Quality Planning
Experience of Project and system auditing, gate review, configuration management
Comfortable solving complex problems; analyzing possible innovative solutions using technical experience and judgment

Ccar / Basel Quality Assurance Professional Resume Examples & Samples

Analyzing identified issues for their impact on capital and other upstream and downstream processes or systems, as well as communicating and escalating observations
Cultivating relationships across the Finance organization with key constituency groups, such as Regulatory Reporting, Product Controllers, Operations, Treasury, Technology, Credit Risk, and Market Risk
Prior audit or consulting experience

Quality Assurance Professional Resume Examples & Samples

Bachelor’s degree in relevant field and 8 years of relevent experience; or
HS/GED and 10 years of relevant regulatory auditing experience
Computer skills, commensurate with Essential Functions and including ability to learn a validated

Quality Assurance Professional Resume Examples & Samples

Be energized by collaborating with cross-functional teams
Providing QA systems process improvement, and product-based support to manufacturing operations, customer service, and design teams
Providing QA systems implementation support to New Product Development teams
Team involvement with operational improvements, document changes, product development, design control, and systems enhancement activities (including equipment, process, and software validation)
Supporting internal nonconformance and customer complaint investigations to ensure effective corrective actions, prevention-based improvements, and post-implementation effectiveness
Partnering/advising various functional teams (e.g., Raw Materials, Inspection, Document Control, Maintenance and Calibration, Environmental Monitoring and Control)
Participating with supplier evaluation, audits, selection and approvals
Assisting with the developing and delivering associate training related to Quality System requirements (e.g.: cGMP)
Participating in activities related to customer and third party inspections or audits (e.g., FDA, ISO Registrar)
Internal compliance auditing
At least 3 years' experience in a Quality Assurance or Quality Engineering role in an industry with high quality demands and regulation/customer requirements
Demonstrated ability to understand complex system requirements and translate them into practical implemented procedures /systems using simple terms
Demonstrated mindset of continual improvement
Demonstrated excellent business judgment and decision making skills
Track record of keeping commitments, owning and driving improvements, and getting solid, tangible results
Demonstrated ability to effectively influence individuals and teams across the organization
Demonstrated strong interpersonal skills (e.g. conflict resolution, teaming, written & oral communication etc.)
Demonstrated ability to understand ISO and GMP quality system principles
Demonstrated ability to drive development of Quality System records and processes during New Product Development projects

Quality Assurance Professional Resume Examples & Samples

Making operational improvements
Performing product development and design control activities
Selecting and approving suppliers
Advising various teams (e.g., raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, etc.)
Reviewing complaints
At least 4 years' experience in a Quality Assurance, Quality Engineering, or related Quality focused role in the medical-device, pharmaceutical, or biotech industry
Sound knowledge of FDA medical-device quality system regulations and ISO medical-device standards

Quality Assurance Professional Resume Examples & Samples

Providing a clear understanding of the Core Technology quality management system requirements (provided by standards, business partners, and regulations)
Giving guidance, interpretation, and assistance in application of quality system procedures and practices that support product realization (e.g., partnering in new product development activities, or assisting in the prevention/correction of quality issues during all phases of operations)
Translating quality standard requirements into productive procedures, practices, and behaviors
Influencing associates to consistently think and act (proactively and reactively) to support high-quality products, while providing the context for, and the value of, performing various activities
Supporting and influencing manufacturing and functional teams in efforts to prevent and correct quality issues during all phases of a product’s life cycle
Demonstrating familiarity with processes and products that they've supported previously; understanding their relationship with the product specification; aware of the process inputs that affect product quality and FFU
Facilitating troubleshooting and problem solving efforts
Certifying that product batches meet requirements for shipment
Reviewing and approving quality related documents
Writing defensible rationales that follow good technical writing practices (background, supporting evidence, broader justiﬁcation and a decisive conclusion)
Championing QSPs (writing procedures; providing training and guidance for application)
Championing continual improvement of the quality management system
Preparing for and participating in customer, third party, or regulatory audits
Conducting internal quality audits and external supplier audits (lead auditor and team member)
Co-facilitating or participating in leadership reviews of quality system effectiveness
Technical degree OR at least 4 years of Engineering, Quality, Operations, or other related experience in a regulated manufacturing environment
At least 3 years of quality-related experience within an ISO or GMP quality system manufacturing environment
Experience in auditing for compliance to requirements and procedures
Experience implementing quality system requirements within a manufacturing environment
Working knowledge of quality system requirements (e.g. ISO 9001, ISO 13485) and typical document architecture
An understanding of the application of statistical tools and techniques, which could include: statistical process control, design of experiments, confidence claims and sampling plans, measurement systems analysis, and gauge R&R
Perception, observation, and attention to detail; ability to distinguish where detail does and does not add value
Curiosity and persistence in problem identification and solution
A systematic thought process during application of procedures or when considering changes; ability to consider broader implications
Experience supporting product development efforts from a quality perspective
Proven track record of building effective relationships, through integrating, partnering and leading by example within the Gore culture
A desire to contribute by providing leadership
Experience working within QSI Released Documents, Engineering Change Request, Corrective action and NCMR databases
Experience serving as a mentor or sponsor
Experience functioning as a lead auditor

Technical Quality Assurance, Professional Resume Examples & Samples

Perform assigned tests to ensure code is functioning as defined
Develop and execute manual scripts to support testing requirements
Prepare test plans and test cases to ensure the product adheres to the system/application requirements
Analyze testing output based upon predefined input
Document and communicate test results to senior team members
Help with reviews of system/application requirements (functional specifications) for quality and completeness
Bachelor's degree in Computer Science, Information Technology or equivalent. Experience will be considered in lieu of degree
Minimum three years of experience in software quality assurance testing including IVR (Integrated Voice Recognition)
Experience on eCommerce, and mobile technologies
Basic knowledge of SQL or Oracle, Microsoft Office applications

Senior Pharmacovigilance Quality Assurance Professional Resume Examples & Samples

Execute the Pharmacovigilance audit program (including audits of Central sites, Affiliates, Licensee, Contractors, specific processes and safety documentation) in support of clinical safety and Pharmacovigilance activities related to UCB products
Play an active role as Business QA in validation of computerized systems supporting UCB’s Pharmacovigilance System
Upon the request of/with the approval of the Head PVQA, perform other tasks within competence (as determined by relevant training, experience and/or qualifications)

Technical Quality Assurance, Professional Resume Examples & Samples

Manage the technical and business aspects of client testing
Review new project business requirements and technical documentation and translate project requirements into testing methodologies
Support CTE Certification specific to CardValet (API), WebServices – using JavaScript/JSON to test the WebServices
Create test strategies, test plans, and execute automated test scripts via web-based simulation tool
Participate on project teams as a subject matter expert
1+ years of experience performing QA over WebServices
Experience OOP, JavaScript and JSON would be necessary
Advances English level B2+
Experience with testing automation
Affinity with the financial industry is desirable
Experience creating and maintaining metrics reports

Quality Assurance Professional Resume Examples & Samples

Supporting, maintaining, and improving all facets of the Quality Management System for ISO 9001 & AS9100 (taking a process approach)
Defining, implementing, training, maintaining, and monitoring processes and procedures to ensure company is meeting all regulatory and QMS requirements
Establishing, maintaining, and monitoring key process indicators (KPI’s) to ensure the company is meeting quality objects and strategic planning goals
Taking the lead during customer audits and source inspections
Conducting and leading projects and investigations across cross functional teams (e.g., technical, operations, regulatory, document control, sales, product management, etc.)
Performing or supporting root-cause analysis and corrective action identification through the use of quality problem solving tools (i.e. 5Why, 8D, Ishikawa Diagram)
Developing Qualification/ Acceptance Test Procedures in compliance with customer requirements
Ensuring that documentation of improvements are completed and approved as needed
Demonstrating initiative and job knowledge by suggesting ideas, discovering new and better ways of accomplishing goals and find innovative, well thought-out solutions to problems
Bachelor's Degree in a technical discipline with at least 7 years' experience in a Quality Assurance related role
At least 2 years of work experience with AS9001 in the aerospace industry
Strong knowledge of or experience with quality system implementation and maintenance
Excellent prioritization, planning, and organizational skills with proven track record of consistently finishing projects, producing results, and driving sustainment
Strong interpersonal skills and a proven track record of working, influencing, and building trusting relationships across functions
Certified as an internal auditor
Experience implementing a QMS process approach

Technical Quality Assurance, Professional Resume Examples & Samples

Ideal candidates are skilled in Requirements Analysis, tests case creation and execution, bug reporting and resolution as well as release preparation and production support, all within an agile environment
Additionally, the person must be team-focused with collaborative team skills (CI, iterative development, etc.) and a strong desire to learn
Experience with agile methodologies and: MSVS/TFS/MTM, ASP.NET, SQL, XML, SOAP and automation testing frameworks preferred
Join a team of bright engineers and business analysts as they create Fiserv's next generation Lending Solution
Work with the development personnel to determine solutions of reported issues
Conduct system evaluation to determine client workflow, document usage, and business procedures to verify proper product usage
2 to 4 years' experience in software industry with an in-depth understanding of QA methodologies associated with Agile/Scrum
Experience working with .NET Web based applications (solid understanding of web application and architecture)
Working knowledge of front-end and back-end applications
Advanced English Level (B2)
Previews experience on programming, database or web development
Previews experience in a financial entity (e.g. bank, stockbrokerage), investment experience, or similar
Microsoft Test Manager, ISTQB

Senior Quality Assurance Professional Resume Examples & Samples

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
Participating in execution of projects, and coordinating other QA staff contribution to projects, ensuring that projects’ QA requirements are well established and understood; quality problems are reported, investigated and promptly addressed; assessments and audits are planned and executed; quality verification is effective and performed as planned; manage supplier quality, administration of non-conformance reporting (ProAct) and corrective and preventive action programs
Preparation, maintenance and assistance in implementation of QA Plans and procedures meeting the requirements of all applicable standards including but not limited to CSA N286, CSA Z299, ISO 9001 and ASME NQA-1 standards as well as all applicable regulatory requirements
Producing and providing oversight on production of QA deliverables, review of various technical documents and records, review of QA requirements for Procurement, QA verification and reporting activities
Participating in Proposal preparation and Contract Review process providing estimates on QA effort, identifying QA requirements and deliverables, and verifying that QA requirements for proposed/contracted scope of work are adequately defined
Providing advice and guidance to project staff as well as his/her own team members on QA standard requirements, and working with the project management and staff to address QA related issues
Relevant Honours Degree from a University of recognized standing, preferably in engineering, plus a minimum of 5-10 years of practical experience in quality assurance
Knowledge of QA standards applicable to nuclear industry, i.e. CSA N286 and N285 series, ASME codes for nuclear and non-nuclear pressure boundary items, CSA Z299, ISO 9001, ASME NQA-1
Knowledge of QA processes applicable to Design and other nuclear quality assurance activities
Ability to prepare, review and accept QA Manuals/Plans, procedures, operating instructions and various product technical and QA documents and records
Ability to read and interpret engineering drawings and review supplier documents including Inspection and Test Plans and inspection procedures
Auditing, self-assessment and root cause assessment skills. Knowledge and use of formal quality assurance problem analysis tools (i.e. root cause analysis) would be an asset

Quality Assurance Professional Resume Examples & Samples

Preparation, maintenance and assistance in implementation of Quality Assurance Manuals, QA Plans and procedures for QA Programs meeting the requirements of CSA N286, CSA Z299, ISO 9001 and ASME NQA-1 standards and applicable regulatory requirements
Planning and administration of audits and self-assessments; and conducting self-assessments, audits and root cause assessments, as required
Administration of non-conformance reporting and corrective and preventive action programs, actions tracking and reporting of performance indicators
Preparation of project QA deliverables and providing assistance to project’s staff in preparation of various procedural documents
Providing QA input to preparation of technical documents and participating in Review & Comment of technical documents
Providing advice and guidance to project staff on QA standard requirements, and working with the project management and staff to address QA related issues
Development of training programs on various QA Program aspects and delivery of that training to project staff
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
Supporting the Licensing group in interfacing with the Regulators on QA matters
Relevant Honours Degree from a University of recognized standing, preferably in engineering, plus a minimum of 3-5 years of practical experience in quality assurance
Knowledge of QA standards applicable to nuclear industry, i.e. CSA N286 and N285 series, CSA Z299, ISO 9001, ASME NQA-1
Knowledge of QA processes applicable to Design and other nuclear life-cycle phase and quality assurance activities

Quality Assurance Professional Resume Examples & Samples

Represent the company at supplier and customer meetings
Liaise and engage with other functions
Support the Head of Quality & Quality Manager and deputise in their absence
Develop & maintain the Business Management System (BMS) to cover all aspects of the company and to safeguard the company’s ISO9001 certification
Facilitate the provision of appropriate processes to enable efficient operation and growth of SMSCMC in accordance with Business Strategy
Chair scheduled management reviews, managing actions to closure and maintaining accurate minutes

Quality Assurance Professional Resume Examples & Samples

Providing hands-on coordination and support for execution of the nonconforming product (NCR) and corrective and preventive actions (CAPA) processes
Providing hands-on coordination and investigation of failure investigations (FIR) from initiation to completion to ensure time-sensitive activities, documentation and approvals are completed
Participating in compliance audits
Advising and working with various teams (e.g. raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, manufacturing, engineering, etc.)
Provide hands-on mentoring and guidance for situational compliance issues
Supporting documentation for new and existing products
Developing quality reports to support assessments of quality system effectiveness
Bachelor’s degree, OR a 2-year degree plus at least 2 years medical device experience in a quality, manufacturing or operations role
At least 5 years of Quality Assurance related experience in a medical-device, pharmaceutical, biotech or other regulated industry
Strong interpersonal and influence skills
Bachelor’s degree in an applicable science or engineering, OR a 2-year degree plus 2-5 years medical device experience in a manufacturing or operations role

Wealth Management Compliance Testing Quality Assurance Professional Resume Examples & Samples

Perform a second review of the work paper documentation and corresponding reports relating to the examinations conducted by Branch Exams, Non-Branch Exams, and Targeted Assessments. These reviews will be detailed in scope and will determine if Global Testing Standards and Risk Based Protocols have been achieved
Work with examination staff and management in order to establish key performance indicators and adjust periodically to changing conditions
Based upon results of quality assurance reviews, advice management on process adjustments and provide training, tools and techniques as applicable
Generate periodic reporting regarding the results of the quality assurance program and key performance indicators to Compliance Management
Maintain an active liaison with Industry colleagues and associates within the Examination field to ensure that our audit practices are up-to-date and adequate, factoring in all relevant Regulatory Requirements and guidance
Develop good working relationships with internal Compliance, Legal and Risk groups
Participate in the Compliance Department’s Efficiency Review Program by providing audit management expertise to the teams tasked with performing such reviews
Act as a catalyst for change and improvement in performance and quality by providing ongoing recommendations to senior exam management to enhance current practices and provide added value to the inspection process
Act as a key contact with Internal Audit during their periodic reviews of the Compliance Inspections area
Ensure that Inspection Department policies and procedures are up to date and reflect real time changes as a result of quality assurance deliverables
5 plus years’ experience within the Internal Audit, External Audit or Compliance Exam related fields
Prior experience in planning and executing audits in accordance with professional standards and a solid understanding of auditing practices, audit metrics and audit reporting processes
Detail oriented with strong written and verbal communication skills
Prior managerial experience preferred
Ability to handle large workload with strong organizational and planning skills

Quality Assurance Professional Resume Examples & Samples

Provide support for the implementation and improvement of Quality Management Systems
Provide Quality support and approval of NCR’s, CAPA’s and Change Controls
Provide Quality input for the development and review of documents
Ensure J&J standards are effectively implemented, and support on-going compliance
Support continuous improvement initiatives through active project participation
Supplier Management including establishing and maintaining Quality Agreements
Provide Quality support for internal, external and corporate audits
Management of recalls and stop shipments
Provide Quality input for the introduction of new product, product divestment and acquisition
Support for product design approval for Special Request Instruments and novel products including Mobile Medical Apps
Enable Business Units in process improvement, systems support and compliance gap remediation
Facilitate the collection of Quality metrics and ensure input into the reporting systems

Quality Assurance Professional Resume Examples & Samples

Be passionate about providing quality assurance support for a world- class manufacturer
Providing Quality Assurance (QA) systems process support while engaging with diverse functional teams including product development, operations, and customer support
Supporting internal non-conformance and customer complaint investigations to ensure effective corrective actions, prevention-based improvements, and post-implementation effectiveness
Acting as the Quality Systems Subject Matter Expert for various functional teams (e.g., Raw Materials, Inspection, Document Control, Maintenance and Calibration, Environmental Monitoring and Control)
Assisting with developing and delivering associate training related to Quality System requirements (e.g.: cGMP)
Auditing for internal compliance
Demonstrated understanding of ISO and GMP quality system principles within a Medical Device, Combination Products, Pharmaceutical, and/or Bioprocessing manufacturing environment

Technical Quality Assurance, Professional Resume Examples & Samples

Requirements Analysis, tests case creation and execution, bug reporting and resolution as well as release preparation and production support, all within an agile environment
Provide input to walkthroughs of Functional and Technical specifications and assist in the process of refining work estimates
Present information effectively in communications with peers and senior project management
Bachelor's degree in Computer Science, Information Technology, or equivalent, or 3 years of experience of experience designing UI for web applications
2-3 years of experience working with Microsoft SQL Server
Working experience w/ .Net, C#, ASP.NET, AJAX and MVC
Understanding and experience developing n-tier applications (using web services, WCF)
Web UI testing experience CSS3/HTML5, Responsive UI (Bootstrap), AngularJS or any web UI frameworks like jQueryUI, Semantic-UI
Previous experience working with Telerik UI is a plus
Knowledge and experience setting up and configuring websites in IIS 7.5 and up

Technical Quality Assurance Professional Resume Examples & Samples

Participate in the Functional and UI design process as required, providing guidance and consultancy to team members and project stakeholders
Design, plan, review and execution of test cases. Document and follow up findings on a timely manner during all stages of application lifecycle
Provide input to walkthroughs of Functional and Technical specifications and assist in the process of refining work estimates and requirements
Demonstrate the ability to present information effectively in communications with peers and senior project management
Work successfully in a team environment and demonstrate a willingness to help team members in achieving their project goals if required
Agile/SCRUM, ISTQB certification, preferred
2 to 4 years' experience in fast-paced software industry with an in-depth understanding of QA methodologies associated with Agile/Scrum on .NET Web based projects
Solid understanding of web application and architecture on both front-end and back-end applications
Ability to document and track defects, as well as produce detailed reports using defect tracking tools during all software development lifecycle
Advanced English Level B2
Experience using Microsoft Visual Studio/Microsoft Test Manager/SQL Server preferred
A plus if the engineer has had programming, database or web development work experience
A plus if the engineer has had work experience in a financial entity (e.g. bank, stockbrokerage), investment experience beyond the average person or experience and/or an understanding of financial regulations, processes and procedures
Experience with consumer lending preferred
Experience working on mobile enabled web applications