Validation Analyst Resume Sample
Allan Predovic
84131 Dooley Locks,
Philadelphia,
PA
+1 (555) 485 1943
Work Experience
Senior Validation Analyst
12/2017
-
PRESENT
Boston, MA
- From the QA process, engage different parties within the business to determine next steps, requirements, and ensure completion of the CAP on a timely basis
- Work closely with CAP Coordinators and Compliance colleagues across the business to identify and raise emerging issues and opportunities
- Comfortable with data entry tasks to assure updates to corporate systems (i.e. iCAPs)
- Experience with data manipulation and analysis using excel
- Partners with Business/CAP owners to ensure that closed CAPs are correctly documented in corresponding corporate systems (currently iCAPS)
- Validate resolution plans to ensure they adequately address the root cause of identified issues found in the business lines and evaluate whether corrective actions are sustainable
- Conduct a detailed review of evidence to support the closure and remediation of issues
- Analyze testing results to verify the adequacy of business line remediation
Validation Analyst
08/2012
-
06/2017
San Francisco, CA
- Conduct credible challenge and provide business line risk management with value added feedback to verify underlying issues risk have been appropriately resolved
- Work closely with business line risk management, subject matter experts, and CBSS Issue Validation management to ensure additional matters of concern arising from the validation are properly remediated prior to the issue closure due date
- Identify trends, including repeat issues and inadequate corrective actions taken by business line
- Assist the Issue Validation Manager with summarization and delivery of the results to the appropriate issue owners, risk management partners and CBSS Chief Risk Officer
- Maintain Knowledge/Awareness of federal and state laws and regulations impacting Consumer Banking activities by monitoring industry news/articles/events, attending conferences, training, etc
- Work with technical teams to develop technical validation requirements and solutions
- Work with technical teams to deliver technical validation requirements and documents
CS Validation Analyst
04/2009
-
06/2012
Philadelphia, PA
- Ensures alignment with IT QA and the project teams requirements for validation
- Act as a resource to the IT Quality team to ensure that the validated state of the applications is maintained through change control and day to day maintenance activities
- Work in a team and serve as tactical IT liaison to the business through building and fostering a partnership
- Demonstrate strong understanding of the business area and its supporting technology as well as broad understanding of overall business unit
- Ensure solution delivery meets business needs and expectations through business requirements gathering process
- Be proactive in identifying solutions or opportunities that can help improve Business processes
- Be point of contact for business focused application questions and be able to identify and leverage resources across IT
Education
Kettering University
2005 - 2009
Engineer's Degree in Computer Science
Professional Skills
- Planning and Organization: Excellent planning and prioritization skills with the ability to multi-task and adapt
- Experience with computer system validation and proven experiencing working on validated projects
- Strong organizational, analytical, troubleshooting and problem-solving skills. Ability to analyses details and perform structured decision-making daily
- Strong organizational, analytical, troubleshooting and problem-solving skills
- Strong people influencing skills and an ability to ‘get things done’ for the business
- Strong troubleshooting skills, with the ability to analyze software defects and explain how errors are produced
- Strong troubleshooting skills and the ability to analyze software defects and explain how errors are produced
How to write Validation Analyst Resume
Validation Analyst role is responsible for software, training, analysis, design, advanced, computer, customer, technical, troubleshooting, organization.
To write great resume for validation analyst job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Validation Analyst Resume
The section contact information is important in your validation analyst 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 Validation Analyst Resume
The section work experience is an essential part of your validation analyst 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 validation analyst responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular validation analyst position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Validation Analyst resume experience can include:
- Model and enhance business process diagrams and other related models to capture business operations change requirements within defined opportunities or projects, modeling both current and future state
- Document or map business processes targeted for change via approved projects, both current and future state. Determine and document the impact of process changes for the process owner
- Solid verbal and written communication skills, including technical/business writing
- Strong meeting management and negotiation skills
- Prior proven experience in testing application in Water Fall or Agile /Scrum development process
- Very good verbal and written communication skills to collaborate with customers and remote team members
Education on a Validation Analyst Resume
Make sure to make education a priority on your validation analyst resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your validation analyst 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 Validation Analyst Resume
When listing skills on your validation analyst 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 validation analyst skills:
- Strong verbal and written communication and documentation skills including the ability to effectively communicate up and down
- Solid interpersonal skills – the ability to establish and maintain good working relationships
- Demonstrate advanced skills in test method development, test fixture design and development, data analysis and report writing
- Strong technical writing and investigation skills required
- Strong troubleshooting skills needed to analyse software defects and the ability to explain how errors are produced
- EU/APAC: Prior proven experience in software testing
List of Typical Experience For a Validation Analyst Resume
1
Experience For Senior Validation Analyst Resume
- Excellent Technical writing skills, especially as it relates to the CAPA/Complaint process and the actions associated with those activities
- Strong computer skills including Microsoft Office and databases
- Excellent facilitation, ,collaboration, verbal and written communication skills
- Previous experience in Quality Assurance, Quality Control, Manufacturing or Engineering is desired, but not an absolute requirement
- Display a solid technical understanding of engineering principles and procedures
- Performs validation/testing activities according to relevant ICON/Sponsor SOP's and appropriate regulations
2
Experience For Data Validation Analyst Resume
- Contribute to improving the team’s validation methodology and execution capabilities
- Perform independent validations of select FRM processes and controls, including interpretation of Basel relevant regulations and implementation thereof
- Assist in coordinating the performance and completion of validation studies in a timely manner.
- Perform other relevant tasks depending on the needs of the global validation department.
- Ensure compliance to governing SOPs, validation plans, and protocols throughout the project
- Proficient in reviewing executed validation documents (automation OQ, deviations, change managements, specifications, summary reports, etc.)
- Create and execute shipping validation test scripts and document test results in accordance with standards
3
Experience For CS Validation Analyst Resume
- Provides support and on-the-job training to more junior or less experienced team members
- Work on model validation reports with hiring manager and provide ad hoc support to him
- Provide training to colleagues and contractors on our approach to systems implementation and validation SOP’s
- Support the regulatory defense of validation protocols and summary reports during regulatory inspections and internal audits
- Support the continuous improvement initiatives for the validation of BSL manufacturing processes, equipment, and facility, utility, and control systems
- Leads/coordinates validation efforts of new equipment and changes to existing equipment
4
Experience For IRE Validation Analyst Resume
- Performs test script execution and completes validation documentation for simple edit checks
- Performs validation/testing activities according to relevant ICON/Sponsor SOP’s and appropriate regulations
- Provide guidance, training, and support to IT personnel in their qualification and validation efforts, to ensure compliance
- Experience with risk analysis and risk management practices and tools
- Experience with Oracle Agile processes and systems. Version 9.3.1 or above, (desired)
5
Experience For Business Validation Analyst Resume
- Prepare accuracy, precision, correlation, or stability samples for validation studies.
- Assist in the preparation of validation plans and reports and in performance of results analysis
- Distribute and/or ship validation, correlation, or stability samples within or to ILS owned facilities and/or collaborators.
- Maintain a readily accessible, up to date electronic library of completed validation, correlation, or stability study statistical experiments
- Be available to assist laboratory in assay validation experiments as necessary.
- Review and evaluate validation assessments for application systems/projects
6
Experience For Risk Process & Data Validation Analyst Resume
- Review/revise Validation Policy and SOPs as directed
- Validation Support for new releases and modifications to applications throughout the Software Development Life Cycle
- Implementation validation and post implementation support
- Experience in Business Analysis or Data analysis
- Expertise with Instrument/Equipment validations
- Create/Update system and validation documentation
- Support the model validation team to mitigate the model risks
7
Experience For Encounter Validation Analyst Resume
- Microsoft Suite experience (Heavy Excel)
- Production application support experience highly desirable
- Responsible as the Site Quality subject matter expert and technical leader for validation study methods, design and regulatory requirements
- Work with Allergan SMEs to develop and execute analytical method validations
- Ensure timely execution, review, and approval of Validation protocols/reports and SOPs
- Support regulatory changes through the provision of necessary validation documentation and change control activities
- Developing new and improving existing Standard Operating Procedures
8
Experience For Spreadsheet Validation Analyst Resume
- Compiling and maintaining the documentation for an assigned project and working closely with Quality Assurance to obtain their sign-off and approval
- Investigating, documenting and communicating software defects
- Assessing ongoing compliance with internal policies and regulatory requirements
- Determining necessary resources for project completion and communicating needs to Group Leader
- Leading testing resources both on site and off shore in daily operational activities for assigned projects
- Communicating status frequently and noting current issues to the Group Leader
- Leading by example with professional and collaborative conduct
9
Experience For Comp Software Validation Analyst Resume
- Understanding of Linux system - able to navigate and work in Linux
- Design and execute core data and data quality testing; reviewing and challenging automated controls and reporting logic
- Provide appeals support by reviewing, researching, investigating, and auditing Part C appeal cases
- Coordinates end-to-end testing efforts with internal and external interfaces, particularly in more complex end-to-end testing situations
- Analytical Problem Solving: Ability to identify, define and resolve problems using a structured methodology
- Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods
- Conduct testing activities according to relevant ICON SOP’s and appropriate regulations
10
Experience For Clinical / Validation Analyst Resume
- Communicate with lead/manager and/or project team regarding system testing progress and issues
- Off hours work sometimes required to implement initiatives and/or support a 24x7 manufacturing and packaging site
- Data mining and web scraping
- Work closely with CAPs Coordinators and Compliance colleagues across the business to identify and raise emerging issues and opportunities
- Partners with Business/CAPs owners to ensure that closed CAPs are properly documented in corresponding corporate systems (currently iCAPS)
- Interface with key stakeholders, governing bodies and business partners
- Develop and maintain record keeping for experiments performed
List of Typical Skills For a Validation Analyst Resume
1
Skills For Senior Validation Analyst Resume
- Good analytical skills, detail oriented with proven organizational skills
- Prior proven experience in testing various applications developed in Java, .Net, Oracle, MySQL and C++
- Strong oral and written communication skills, and the ability to teach others
- Client-focused approach and strong interpersonal skills
- Strong oral and written communication skills and the ability to teach others
- Experience –engine related systems experience (Design/Simulation/Validation)
- Experience – min. 2 years of experience with FMEA facilitation & validation execution
- Hands on Experience: Direct experience in the creation and execution of validation protocols
2
Skills For Data Validation Analyst Resume
- Programming Skills - MS-Access, VBA, Excel
- Lead/support shipping validation efforts and deliverables for projects requiring shipping validation
- Recent relevant verification and validation (V&V) testing experience, including (in-house, co-op or acquired outside)
- Laboratory and processing equipment validation experience
- Prior role with consulting or internal/external audit experience
- Fundamental training, knowledge, and experience with systems and software validation processes
- Support development and implementation of company policies regarding validation and cGMPs to proactively champion validation initiatives to meet the same
- Fundamental training, knowledge and experience with computer systems validation
- Experience performing instrument validations
3
Skills For CS Validation Analyst Resume
- Highly skilled in Computerized System testing and validation in the healthcare industry
- Experience in validation and / or commissioning required
- Solid knowledge of quality system validation processes
- Other degrees acceptable with 3-5 years of relevant and recent validation/qualification experience
- Advanced science and math skills
- The ability to effectively develop and manage complex project plans
- Computer skills; MS-Office, MS-Project, Pro-E
- Previous experience in writing and executing Method Validation protocols and reports
4
Skills For IRE Validation Analyst Resume
- Preparation of Validation Plans, Test Cases and Validation Summary Reports and executes Test Cases
- Understanding of GxP, GAMP, CFR’s as they relate to validation
- Understanding of the validation life cycle
- Enable data validation execution through designing and execution of core data test/ reviewing and challenging of automated control/reporting logic
- Experience analyzing and solving Medicare beneficiary and/ or provider issues in an office setting environment
- Experience analyzing and solving Medicare beneficiary and / or provider issues in an office setting environment
- Legal training, credit college training, or comparable commercial banking experience
- Experience in SDLC/CSV/Qualification Lead roles (and/or leading testing teams) on software Development or IT-related projects
- Experience with developing test cases for verification testing of micro-controller based embedded mixed signal hardware systems
5
Skills For Business Validation Analyst Resume
- Experience conducting worst-case circuit and timing analysis of analog and digital circuits
- Experience with core banking, investment and trading products, regulations and typologies
- Experience with core banking, investment and trading products
- Experience utilizing Microsoft Office Products including Word, Excel and Power Point
- Strong working knowledge of Microsoft Office suite, including Excel and Word
- Solid understanding of and capability of debugging electronic printed circuit boards
- Experience in Script writing, edit check testing in Rave, InForm, OC or OCRDC
6
Skills For Risk Process & Data Validation Analyst Resume
- Priorities and to manage multiple assignments with challenging/conflicting deadlines
- Leverage testing observations to contribute to improving the team’s validation methodology and execution capabilities
- Maintain the validation program for computer systems, facilities, equipment, manufacturing processes, and cleaning activities
- Technical Expertise: Thorough understanding of validation concepts, current and emerging trends
- Support execution of governance, risk assessment, process review and validation, monitoring and reporting
- Claims processing experience required
7
Skills For Encounter Validation Analyst Resume
- Experience with the design, development and verification of electronic medical equipment containing embedded micro-controller based mixed signal hardware
- Mortgage Banking experience
- Experience in using MS Word to create and maintain files
- Experience in using MS Outlook to manage emails and calendar invites
- More than 2 years of experience with systems or programming tools in use within the contract research organization (CRO)/pharmaceutical industry
- Good understanding of the software development life cycle (SDLC)
- Good understanding of IFRS / risk management concepts, e.g. Basel
8
Skills For Spreadsheet Validation Analyst Resume
- Subject matter or domain experience working in related industries
- Experience with systems or programming tools within the CRO/Pharmaceutical industry
- Experience with systems or programming tools in use at PPD or within the CRO/Pharmaceutical industry
- Experience in using Microsoft Outlook to manage emails and calendar invites
- Experience in using Microsoft Word to create and maintain files
- Strong technical understanding of the financial services regulatory environment , with a focus on Basel principles
- Experience- 2-5 years in medical device industry with test engineering background
9
Skills For Comp Software Validation Analyst Resume
- Experience with systems or programming tools in use within the CRO/pharmaceutical industry
- Knowledge and experience in the following areas
- Strong understanding of GDP and GLP
- Experience with relevant banking, regulatory and end-to-end loan process matters
- Experience with PC based mainframe systems, loan accounting system (AFS), and DEALS
10
Skills For Clinical / Validation Analyst Resume
- Strong working knowledge of computers, math and electronic designs
- Advanced skill in soldering, both surface mount and thru-hole
- Experience with engine testing is desirable
- Experience programming with SAS, SQL, and VBA
- Establish and maintain effective working relationships with peers, business line managers, and colleagues across the bank
List of Typical Responsibilities For a Validation Analyst Resume
1
Responsibilities For Senior Validation Analyst Resume
- Performs Edit Check/Listing validation activities according to relevant ICON/Sponsor SOP’s and appropriate regulations. Reviews Data Validation/Listing Specification (DVS) document created by study team. Tests the clinical study database, as per procedure. Executes formal test scripts and reports test results accurately in a timely manner
- Previous experience supporting Sales & Marketing
- Support order-based activity by reviewing customer prints and specifications to validate the company’s product meets all customer requirements
- Good understanding of clinical trial operational processes and terminology
- Good understanding of operational processes and GMP terminology
- Experience in applying information systems solutions to business problems
- Experience with using HP ALM
2
Responsibilities For Data Validation Analyst Resume
- Demonstrated understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines
- Provide QA review of executed validation documents such as protocols, deviations, and change managements
- Partner with cross-functional business teams, Risk Business Analysts Team and technology delivery teams to support all aspects of Business Validation needs
- Review requirements from business users perspective to ensures the Validation plans cover business requirements
- Conducting verification testing on new product designs including executing test cases and documenting results in a highly disciplined controlled manner
- Create methodologies for providing software testing support for the company’s products and assist in implementing these methodologies
3
Responsibilities For CS Validation Analyst Resume
- Conduct testing activities according to relevant ICON Standard operating procedures (SOP’s) and appropriate regulations
- Position requires standing and walking for extended periods of time
- Provide strategic guidance on applying right-sized, risk-based approach to CSV
- Release equipment back to GMP manufacturing as part of change control
- Have the ability to independently assess impact and re-testing requirements in the event of a deviation
- Work in alignment with business users to identify and document business test cases and their testing approach
4
Responsibilities For IRE Validation Analyst Resume
- Assists in coordinating the implementation of changes to improve performance
- Records and analyze results of testing sessions, prepares summary reports, and presents results
- Provides regression testing of product changes
- 1) Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate
- Troubleshoot desktop and mobile computing devices, network and peripheral issues
5
Responsibilities For Business Validation Analyst Resume
- Track issues/incidents in the internal tracking system
- Supports the manufacturing plant through implementation of process improvements
- Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, VIP measurements and implements/drives improvements
- Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal
- Track & Report on NPI Issues & managing NPI Issue Resolution
- Perform troubleshooting and calibration of instruments
- 7) Ability to solve routine design, engineering problems with assistance
- Mentor to Engineer colleagues executing containment and integration checks
- Attain, maintain, and apply a working knowledge of GCPs, applicable SOPs/WPDs, and process maps
6
Responsibilities For Risk Process & Data Validation Analyst Resume
- Review and critique SDLC documentation, including requirements, functional designs, system designs, and test plans
- BS in relevant Engineering/Science field
- With minimal guidance, schedules and leads an activity through the planning and execution
- Knowledge of the basic principles in various engineering disciplines
- 2) With minimal guidance, schedules and leads an activity through the planning and execution
- Support ongoing status dashboards for project leadership
- Attain, maintain and apply a working knowledge of cGMPs, applicable SOPs/WPDs, and Process Maps
- Analyze details and perform structured decision-making on a daily basis
7
Responsibilities For Encounter Validation Analyst Resume
- Possesses working knowledge of functions of other units in department
- Oversight for reporting on 2-3 Medicaid plans
- Periodic lifting of up to 35 pounds
- Analysis & Testing
- Maintains and completes study documentation in a timely manner
- Communicates with test lead and/or team regarding system testing progress and issues. Works closely with other supporting departments to ensure all testing issues are resolved in a timely manner and study timelines are met
- Attends and assists with audits. Participates in and contributes to internal user group meetings to share knowledge and provides latest update/features. Participates in Data Management department initiatives
- Serving as a member of the Validation oversight department responsible for Computer System Validation for IT systems, including defining/authoring all relevant SOP and Policy implementations; ensuring that all validation requirements have been met prior to system release
- Managing validation efforts and drafting/reviewing/approving/executing validation lifecycle documents related to computerized laboratory systems supporting in-process/release testing
8
Responsibilities For Spreadsheet Validation Analyst Resume
- Ensuring that validated computerized systems are maintained in a manner compliant with corporate and regulatory requirements (including 21 CFR Part 11), as well as maintaining their validated state through periodic system review and effective system administration (user management, data management, preventative maintenance, etc.)
- Serving as validation SME for Lilly-NJ during all company-wide audits and providing support in the performance of vendor audits for validated computerized laboratory systems
- Working with internal staff including technical staff, project and product managers and applications developers to assist with the review of project specifications
- Isolate defects in the software and report them in the quality tracking system. Interact with developers to help issue resolution.
- Approve system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support infrastructure qualification and system validation activities
- Represent IT Quality & Regulatory Compliance on cross-functional teams in support of SDLC activities
- Consult on the authoring and conformance of qualification and validation related deliverables and activities in regard to corporate SOPs and current regulations
- Assist in the development of IT Controls templates (SDLC deliverables, System Assessments, etc.)
9
Responsibilities For Comp Software Validation Analyst Resume
- Assist in the rollout of Quality Risk Management practices for IT
- Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines
- Detailed knowledge of the general computerized system development life cycle in a regulated environment and software quality assurance
- Supply technical guidance on corporate and site CSV policies and procedures
- Ensure CSV deliverables are appropriately reviewed and meet all requirements of corporate and site CSV policies and procedures
- Implement processes to maintain CSV compliance
10
Responsibilities For Clinical / Validation Analyst Resume
- Escalate CSV issues immediately to appropriate people
- Apply/share standard CSV best practices across Lilly
- Partner with customers to understand the business
- Create, revise, and implement CSV related documentation, ensuring all document are well written, usable/executable, and compliant with Corporate and Local policies and procedures
- Provide appeals support by reviewing, researching, investigating, and auditing Part D appeal cases
- Work with Product Lifecycle Management (PLM) system users and stakeholders to schedule testing cycles
- Create work schedules to enable changes to progress and complete on time, gathering input from IT team and business
- Work with company SDLC to implement small and large projects. Identify and update all documentation for all PLM projects
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