Validation Analyst Resume Samples
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Validation Analyst Resume Samples
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EL
E Lindgren
Era
Lindgren
50463 Cummerata Mills
New York
NY
+1 (555) 583 2635
50463 Cummerata Mills
New York
NY
Phone
p
+1 (555) 583 2635
Experience
Experience
San Francisco, CA
Validation Analyst
San Francisco, CA
Rogahn, Feeney and Luettgen
San Francisco, CA
Validation Analyst
- Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance
- Running validation tests, producing validation output summaries and assisting in the interpretation of test conclusions
- Assisting in the production of validation reports throughout the year
- Assisting in developing and maintaining a robust technical validation framework
- Assisting in the validation of model changes implemented by the Capital Modelling Team
- Create high quality QAT validation reports that are consistently clear, factually accurate and concise
- Isolate defects in the software and report them in the quality tracking system. Interact with developers to help issue resolution
Detroit, MI
Senior Validation Analyst
Detroit, MI
Block and Sons
Detroit, MI
Senior Validation Analyst
- Working with application developers in resolving issues and retesting applications
- Creating associated validation documentation using defined documentation methods
- Communicate with test lead and/or project team regarding system testing progress and issues
- Developing and utilizing test data sets that support the implementation of test plans and procedures
- Coordinate internal testing projects such as core testing efforts and tools/application solutions projects
- Tracking all software versions, features, bugs and validation efforts for all software created and/or modified by the Development teams
- Exploring new opportunities to add value to organization and departmental processes
present
Boston, MA
Software Validation Analyst, Intermediate
Boston, MA
Cummings, Schinner and Keeling
present
Boston, MA
Software Validation Analyst, Intermediate
present
- Assists in the development of schedules and budgets and associated progress reporting
- Develops product knowledge through formal and informal training, OJT, and self-study
- Investigates test anomalies through analysis of data files, design documentation and interaction with development departments
- Create accurate and concise test procedures
- Participates in marketing activity by estimating new project work costs, drafting proposed commissioning and cut over plans and responding to project RFQs
- Perform the independent review of test results
- Performs commissioning tests in plant and at project sites
Education
Education
Bachelor’s Degree in Computer
Bachelor’s Degree in Computer
Emory University
Bachelor’s Degree in Computer
Skills
Skills
- Ability to attain, maintain and apply a working knowledge of GCPs, applicable SOPs/WPDs, and Process Maps
- Demonstrable evidence of interpreting & manipulating data clearly and accurately with the ability to extract & clearly articulate key points
- Strong attention to detail and problem solving skills
- Good organization skills and time management skills with the ability to adapt and adjust to changing
- Strong oral and written communication skills and ability to teach others
- Ability to establish and follow robust, logical and auditable processes to complete a task or project
- Excellent attention to detail and a meticulous eye for identifying inconsistencies or inaccuracies in data entry or data outputs
- The role would suit highly driven self-starters, with a strong desire to challenge and deliver
- Ability to build effective working relationships (internally/externally), establishing credibility amongst a wide and demanding client group (if applicable)
- Client focused approach with strong interpersonal skills
15 Validation Analyst resume templates
Read our complete resume writing guides
1
Credit Validation Analyst Resume Examples & Samples
- Candidate should have advanced degree in Economics, Statistics, Mathematics or related field with 2 to 5 years of experience
- Programming background in SAS is required. Familiarity with VBA, C/C++, SQL, MATLAB, SPSS, S-Plus, R is preferred
- Knowledge of credit risk management, economic capital and stress testing concepts
- Strong verbal and written communication skills are necessary (ability to explain complex ideas in simple, non-technical language)
- Strong background and practical experience working with statistical and econometric concepts
- A strong aptitude to independently perform and reproduce technical calculations
- Advanced analytical abilities and the ability to work efficiently and effectively with multiple managers across the bank
- Familiarity with Linear Algebra
- Strong critical thinking skills to provide effective challenge to models developed internally and by vendors
2
External Validation Analyst Resume Examples & Samples
- Review and prepare ISDA documentation, both structured and vanilla, applying information from deal tickets, broker confirmations, counterparty specific information and term sheets and trade booking systems
- Review and resolve queries on confirmations with front office, trade management and other departments to obtain additional information as required and to resolve discrepancies
- Deliver proactive, prioritised service to all clients, with special attention to Key Accounts and Platinum clients
- Delivery results in reaching new regulatory requirments on confirmation timeliness
- Review existing approved ISDA. Ensure approved CS templates are maintained and refreshed to reflect most recent ISDA and industry best practices and approved Legal and Front Office approvals
- Demonstrate initiative in participating in projects, process inprovements
- Organise and prioritise workload, be aware of deadlines and ensure that they are met
- Checks through all queues at EOD ensuring all comments are updated and trades are adhering to Daily Control Checklist
3
External Validation Analyst Resume Examples & Samples
- 2 years Investment Banking Experience processing OTC Derivatives
- Pro-active and highly motivated with a willingness to learn
- Good English communication skills, both oral and written
4
Risk Process & Data Validation Analyst Resume Examples & Samples
- Support execution of governance, risk assessment, process review and validation, monitoring and reporting and technology strategy as it relates to results and MI reporting
- Strong risk, process and control validation/testing and/or assessment skills. Prior role with consulting or internal audit experience is an advantage
- Strong technical understanding of the financial services regulatory environment, with a focus on Basel principles as it relates to Market, Credit and Operational risk capital requirements and practices
5
Operations Document Validation Analyst Resume Examples & Samples
- Validate client documentation is executed properly and accurately according to Chase purchasing requirements
- Place conditions on loan for correspondent to review when a document does not meet guidelines
- Exception processing due to review of detailed feedback from correspondents in response to deficiencies notated on their file
- Experience in a prior compliance, closing, processing, title or underwriting role preferred
- At a minimum, must be familiar with the following documents as applicable: FHUD, TIL< GFE, Note, Credit Reports, Tax transcripts, W-8/W-9, IRS 4506-T and Underwriting forms such as a DU or LP. FHA and VA document reviews are required as well. Must be able to review employment, income and asset documentation
- Competency with the following applications as applicable: Microsoft Word, Outlook and EXCEL, ADOBE Acrobat, FHA Connection and Web searches
6
IPB Control & Validation Analyst Resume Examples & Samples
- Experience in audit / examinations environment is a must
- 5+ years of previous banking experience (AML and Operational Risk Management experience is a plus)
- Bilingual in English/Spanish is a plus
7
Senior Issue Validation Analyst Resume Examples & Samples
- Seven to ten years of experience in an applicable risk management environment
- Bachelor’s degree in accounting or relevant area of study
- A combination of at least seven years progressive experience in public accounting, federal regulator, financial institutions, internal audit, and/or consulting
- Ability to analyze and clearly identify underlying issue risk, measurement criteria, cause, exposure and recommendations
- Strong oral, written, interpersonal, communication, relationship building and persuasion skills
- Background in regulatory laws and regulations with consumer and small business focus
- Strong accuracy and attention to detail
- Federal Regulator, Financial Institution Internal Audit, or Big 4 experience
- Prior leadership of staff that perform testing/monitoring activities
- Experience with TeamMate Electronic Work Papers package
- Accountable for and able to manage time effectively and work under minimal supervision both individually and as part of a team
- Ability to plan, analyze, and coordinate issue validation projects effectively
- PC literacy (MSWord, Excel, Access, electronic mail such as Lotus Notes or Outlook)
- Applicable professional certifications (CIA, CPA, CAMS, CFE, etc.)
8
Data Validation Analyst Resume Examples & Samples
- Work in a highly collaborative environment with minimal supervision
- Ability to work on multiple priorities and/or projects simultaneously
- 2 years’ experience
- Ability to multitask and meet strict deadlines
- SAS and R experience also a plus
9
Associate Validation Analyst Resume Examples & Samples
- Support internal software validation on deployed instrumentation and enterprise platforms
- Support Operations staff on deployment of GMP instrumentation
- Performs unit system testing to include review and approval of instrument computer software systems
- Assists in developing Standard Operating Procedures and testing procedures for emerging technologies and performance qualification (PQ) regiments for existing technologies
- Assists in the periodic review of software life cycles
- Provides support to department investigation teams regarding Deviations, or discrepancies observed during CSV execution
- Demonstrate proficiency in application of quality principles, concepts, and practices
- Have good communication and writing skills. May be required to talk with auditors and regulatory compliance officials
- Requires 4-yr degree in computer, biological or life sciences or related area, or equivalent combination of education, training and professional experience that provides the required knowledge, skills and abilities
- Fundamental training, knowledge and experience with systems or software validation processes
- Competent with MS Word, MS Excel, MS PowerPoint
10
Senior Validation Analyst Resume Examples & Samples
- 50% Serves as Validation Support for new releases and modifications to applications throughout the Software Development Life Cycle. Prepares Validation Plans, Test Cases and Validation Summary Reports and executes Test Cases. Reviews and approves all change controls associated with the validated systems per SOP. Reviews PQ and change control documentation with the IT Project Manager per SOP. Meets with project teams on a regular basis to ensure effective communication and accuracy in testing. Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer. Updates test scripts where required based on requirement changes or upgrades in application functionality. Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably proving the software functions correctly. Creates, updates, and manages data within the testing environment sufficient to accurately test software functionality. Works with IT Project Manager to address any PQ related issues arising from client or internal audits
- 20% Supervises the daily activities of other validation analysts or associate validation analysts performing the same or similar tasks. Assigns, monitors and reviews progress and accuracy of work. Directs efforts and provides technical guidance on more complex issues. May be required to complete tasks of subordinates when the need arises. May initiate and communicate a variety of personnel actions (e.g. performance and salary reviews, time off requests, timesheet and expense report approvals)
- 15% Manages assignments to meet deadlines and produce high quality deliverables. Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs/WPDs. Monitors own assignments; evaluates and shifts priorities and assignments to meet deadlines and deliver high quality work. Communicates pro- actively with all Project team members and provides regular feedback to management concerning timeline/budget or resource constraints
- 10% Participates in departmental and corporate process initiatives. Cross trains and mentors validation analysts on systems of expertise. Trains personnel resourced to validate software releases, including internal testers, contractors, and temporary employees
- 5% Prepares for and represents department within relevant system related client / audit forums. Represents IT Validation in sponsor audits. Participates in or conducts vendor audits as appropriate for tools or systems in use
- Fundamental training, knowledge and experience with systems and software validation processes
- 4 years experience with systems or programming tools in use at PPD or within the CRO/Pharmaceutical industry
- Experience in clinical research, or alternatively in another highly regulated technical environment
- Competent with MS Word, MS Excel, MS PowerPoint, MS Project
- Demonstrates positive attitude, enthusiasm toward work and the ability to work well with others
- Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
- Good understanding of clinical trials operational processes and terminology
- Good understanding of software development life cycle (SDLC)
- Proven ability to learn new computer software with minimum of instruction
- Strong troubleshooting skills needed to analyze software defects and the ability to explain how errors are produced
- Ability to assess the cause of test failures
- Ability to realize validation process needs and provide solutions
- Demonstrated experience in identification and resolution of technical problems in a professional environment
- Ability to develop and maintain Project Schedules within MSProject
- Must be able to set and meet timelines and be able to negotiate schedule changes in response to project demands
11
Validation Analyst Resume Examples & Samples
- In depth knowledge of business functional area with strong understanding of business unit (Or if new to business area, shows strong learning agility to achieve in depth knowledge)
- Understands the technology offerings applicable to the business when assisting in the design of solutions
- Has knowledge of and utilizes software lifecycle methodologies
- Systems validation experience (depending on skill level — more time for advanced skills and commensurate salary), especially experience that leverages technology as part of the solution
- Experience working on projects in a collaborate team environment
- Good interpersonal, verbal and written communication, including good presentations
- Builds excellent relationships with key internal and external customers based on trust and confidence
- Minimum travel both domestically and internationally
- Support vendor lifecycle activities as required - Application Change
12
Operational Risk Process Validation Analyst Resume Examples & Samples
- Partner with Model Validation and Regulatory Reporting teams to support a unified validation program end-to-end
- Strong technical understanding of the financial services regulatory environment, with a focus on Basel principles as it relates to Capital and Federal Reserve Capital Planning capital requirements and practices
- Series 7, 46 or 99 would be advantageous
13
Validation Analyst Resume Examples & Samples
- Requires 4-yr degree in computer, biological or life sciences or related area, or equivalent combination of education, training and professional experience that provides the required knowledge, skills and abilities
- 2 years experience with systems or programming tools in use at PPD or within the CRO/Pharmaceutical industry
- Client focused approach with strong interpersonal skills
- Strong oral and written communication skills and ability to teach others
- Ability to attain, maintain and apply a working knowledge of GCPs, applicable SOPs/WPDs, and Process Maps
- Ability to review and critique SDLC documentation including Requirements, Functional Design, System Design, and Test Plans
14
Computer Validation Analyst Resume Examples & Samples
- Work closely with internal and external teams to provide the necessary design, configuration, deployment, and support during the implementation of the client's computer system
- Validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, and Standard Operating Procedures
- Managing Vendor Installations and Vendor Validation Documentation
- Test Execution and Deviation Management
- Planning and scheduling of validation and Validation Lifecycle deliverables
- Seven years experience in a regulated industry or 5 years with related technical knowledge including data integrity related to quality control data from chromatographic systems. Experience with laboratory metrology and instrumentation compliance. Project Management and/or prior management experience preferred
- Experience with SAP, EDMS, Trackwise, or similar systems
- Candidates should have strong Biotechnology and Pharmaceutical process understanding
- Candidate must have strong communication and organizational skills
- Understanding of the Validation Lifecycle (GAMP 5)
- Understanding of GxP, GAMP, CFR’s as they relate to validation
- Understanding of applying SOPs, work instructions, and regulatory requirements for validation of computerized systems
15
Validation Analyst Resume Examples & Samples
- Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance
- Travel (approximately 2%) domestic and/or international
- Conduct testing activities according to relevant ICON SOP’s and appropriate regulations
- Write and execute formal test scripts and complete associated documentation and ensure test results are reported accurately
- Assist in validation plans and reports and in performance of results analysis
- Import data as needed into a statistical analysis tool evaluator
- Maintain a readily accessible electronic library of completed validation or stability study statistical experiments
- Able to assist laboratory in assay validation experiments
- Prepare accuracy, precision, correlation, or stability samples for validation studies
- Complete test script writing and execution for simple to moderate complexity systems
- Communicate with lead/manager and/or team regarding system testing progress and issues
- Complete assigned tasks within timeline constraints and report any quality issues to lead or manager in a timely manner
- Other responsibilities may be assigned as required
- Experience in assay validation in a clinical laboratory setting
- Bachelors Degree in Medical Technology, Biomedical or equivalent science
- Minimum 5 years of experience in software testing
- Successfully manage multiple tasks and timeline
- Liaise professionally with team members and system users
- Basic understanding of SQL and database concepts
- Perform assigned tasks with minimal supervision
16
Ibmo Equities Validation Analyst Resume Examples & Samples
- Trade Validation and new deal analysis review
- Ensure all the trade economics, pay-off profiles are correctly captured in the risk management system
- Management of daily MI and Approximate Booking
- Provisions calculation and analysis
- Analysis of trading portfolio including obtaining expert product knowledge
- Performance and monitoring of Key Controls and Reconciliations
- The role will require close contact with various Ops teams, IT and the front office, and clients so good communication skills are essential to this role
- Ensure any areas of concern are identified and escalated to senior management and the business as necessary, while attempting to implement both short term and long term resolutions if the problem is reoccurring
- Manage available time to ensure most efficient team output, while ensuring no controls are compromised.The role holder will also be required to feed requirements and attend working groups related to the build out of our strategic architecture to ensure that all the validation/deal review requirements are taken into account. This will also need to be effectively communicated through to our offshore team and the necessary training is provided to ensure that new processes are implemented effectively
- This section should include
- This is a challenging role with a wide variety of exotic products and high volumes environment with various deadlines to meet on a daily basis, candidate must be able to think on their feet and have a high level of competency in many skill sets
- The role is suitable for candidates who are detail-oriented with strong communication both written and verbal skills
- Minimum of two years experience working with exotic derivatives in a trade support or similar non-Back Office line function in an Investment Bank or equivalent institution
- Experience and understanding for trade lifecycle and familiarity with, complex payout calculations
- Strong people influencing skills and an ability to ‘get things done’ for the business
- A systems-based approach, understanding workflow diagrams and decision trees. This informs a significant amount of our day-to-day in resolving issues with structures
- Good sense of timeliness and can work under pressure to observe the deadline
17
Business Validation Analyst Resume Examples & Samples
- Previous experience in a regulated environment is desired (2-5 years of computer system validation experience and 3+ years of overall industry experience desirable)
- 2+ years experience and knowledge of regulatory requirements related to computer system validation (including 21 CFR Part 11)
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
- Must maintain a working knowledge of cGMP and cGXP regulations related to laboratory and database applications
- Must have the ability to manage multiple, simultaneous projects, ensuring that deadlines are met (being responsive reliable and flexible to shifting demands)
- Excellent teamwork and communication skills (both oral and written) required
- Ability to take initiative, to be assertive, and to build quality working relationships
- Must maintain good problem solving, project management, and organizational skills
- Experience with the validation of stand-alone and client/server systems desired
- Understanding of analytical methods used in laboratory operations is desired
18
Senior Validation Analyst Resume Examples & Samples
- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance
- Travel (approximately 5%) domestic and/or international
- Conduct testing activities according to relevant ICON Standard operating procedures (SOP’s) and appropriate regulations
- Write and execute formal test scripts and complete associated documentation and ensure test results are reported accurately
- Complete test script writing and execution for moderate to complex systems
- Function as testing lead for assigned projects including, but not limited to, planning the test effort and write test scripts ensuring system performs as intended
- Communicate with test lead and/or project team regarding system testing progress and issues
- Liaise with technical project manager in the testing and implementation of systems
- Coordinate internal testing projects such as core testing efforts and tools/application solutions projects
- Mentor/train other staff members as required
- US/LATAM/CAN: minimum 7 years of experience in software testing
- EU/APAC: In depth proven experience in software testing
- Successfully manage multiple tasks and timelines
- Liaise successfully with other teams and clients
- Moderate understanding of SQL and database concepts
- US/LATAM/CAN: minimum 1 year of experience in Test Automation Tools or Application Lifecycle Management (ALM) is preferred
- EU/APAC: Prior relevant experience in Test Automation Tools or Application Lifecycle Management (ALM) is preferred
- In depth proven experience in testing application in Water Fall or Agile /Scrum development process is preferred
- In depth proven experience in all aspects of Software testing Life Cycle (STLC) such as Test Plan preparation, Test Script preparation, Test execution, Defect reporting and tracking is preferred
- In depth proven experience in Black Box Testing, Graphical User Interface (GUI) Testing, User Acceptance Testing, Database Testing, System, Functional, Smoke, Sanity, and Regression Testing is preferred
- In depth proven experience in testing various applications developed in Java, .Net, Oracle, MySQL and C++ is preferred
- In depth proven experience in testing Web Services is preferred
- Perform assigned tasks with little or no supervision
- Bachelor’s degree, or local equivalent, in information systems, science, or related discipline or relevant experience
- An alternative combination of experience, education and training determined by management to be equivalent to the foregoing
19
Independent Verification & Validation Analyst Resume Examples & Samples
- Participating in the IV&V/testing of federal information systems through all phases of the system life-cycle. In areas including but not limited to
- Design, development, testing, and documentation of computer programs
- Database planning and design
- Network services
- Data/records exchange and management
- Resource and facilities management
- Systems analysis and design
- Providing in IV&V Support Services Including
- Bachelor degree in information systems management, business administration, technology management, or related disciplines. Graduate degree is a plus
- Five or more years of experience working on large federal IV&V project
- Certifications/experience in areas such as: Project Management, Information Technology Infrastructure Library (ITIL), Capability Maturity Module Integration, and other software and software engineering certifications are a plus
- Strong problem solving, analytical, time management, organizational skills
- Self-directed and detail oriented, as well as being able to work as a part of a team
- Proficient in use of MS Office is required. Experience in the following are a plus
20
Validation Analyst Resume Examples & Samples
- Serves as Validation Support for new releases and modifications to applications throughout the Software Development Life Cycle. Prepares Validation Plans, Test Cases and Validation Summary Reports and executes Test Cases. Reviews and approves all change controls associated with the validated systems per SOP. Reviews PQ and change control documentation with the IT Project Manager per SOP. Meets with project teams on a regular basis to ensure effective communication and accuracy in testing. Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer. Updates test scripts where required based on requirement changes or upgrades in application functionality. Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably proving the software functions correctly. Creates, updates, and manages data within the testing environment sufficient to accurately test software functionality. Works with IT Project Manager to address any PQ related issues arising from client or internal audits
- Supervises the daily activities of other validation analysts or associate validation analysts performing the same or similar tasks. Assigns, monitors and reviews progress and accuracy of work. Directs efforts and provides technical guidance on more complex issues. May be required to complete tasks of subordinates when the need arises. May initiate and communicate a variety of personnel actions (e.g. performance and salary reviews, time off requests, timesheet and expense report approvals)
- Manages assignments to meet deadlines and produce high quality deliverables. Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs/WPDs. Monitors own assignments; evaluates and shifts priorities and assignments to meet deadlines and deliver high quality work. Communicates pro- actively with all Project team members and provides regular feedback to management concerning timeline/budget or resource constraints
- Participates in departmental and corporate process initiatives. Cross trains and mentors validation analysts on systems of expertise. Trains personnel resourced to validate software releases, including internal testers, contractors, and temporary employees
- Prepares for and represents department within relevant system related client / audit forums. Represents IT Validation in sponsor audits. Participates in or conducts vendor audits as appropriate for tools or systems in use
- 0-4 years experience with systems or programming tools in use at PPD or within the CRO/Pharmaceutical industry
- Experience in clinical research, or alternatively in another highly regulated technical environment preferred
- Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team
21
AP Validation Analyst Resume Examples & Samples
- Ensure the timely and accurate validation of invoice data captured during the scan process using Kofax Batch Manager with a minim of 500 invoices cleared through Kofax per day, covering any legal entity
- Research and resolve data capture discrepancies, utilizing various tools including SAP master data and other data lookups
- Reject invoices or vendor statements captured erroneously, and delete batches as necessary
- Manage backlog of batches to ensure that Bucharest Finance Hub Service Level is met
- Manage batches that fail SAP export and work with IT to resolve when necessary
- Review invoices for required data elements and communicate with vendors when missing
- Participate in process improvement projects as requested
- Perform other special projects and tasks assigned by the direct supervisor in accordance with the professional experience and area of expertise
- 1+ years of accounting support experience in a professional office environment
- Proficient working with Microsoft Office suite, including Word, Excel and Outlook
- Adaptable to learning new software applications and troubleshooting issues when necessary
- Language requirements: Romanian and fluent in English (comprehension, written and speech); other languages a plus
- Capacity to perform highly, both individually and within a team
- Required to manage a large volume of work and data entry
22
Validation Analyst Resume Examples & Samples
- Demonstrates working knowledge of Lean and Six Sigma processes and techniques in accordance with cGMP's
- Analyzes standard technical process problems and implements resolution with moderate guidance
- Performs standard process capability studies and process optimization with moderate guidance
- Assesses standard supplier processes and perform supplier audits and selection with moderate guidance
- Supports external resource/contractors as required
- Gains consensus from various parties involved
- Encourages informed Risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources
- Proactively develops and maintains technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices
- Supports the validation function by developing and executing qualification protocols, compiling data, and writing reports
- Participates in new product scale-up, process optimization, technology transfer and process verification and validation activities
- Lead project teams responsible for implementation of process enhancements
- Maintain validation schedule and validation files
- May perform environmental testing, laboratory testing, or process monitoring activities
- Responsible for the change control, deviation, and CAPA systems for all validated processes and equipment
- Work with Engineering, QC, and Maintenance in equipment purchase requirements as it pertains to validation
- Reviews batch records and supports batch record reconciliation
- Collects process data for process trending and monitoring
- Functions as system owner for computer systems, ensuring changes are managed properly and validated state is maintained
- Bachelor's Degree or the equivalent in Science, Technology, or Engineering preferred
- At least 2-5 years of relevant work experience as a Validation Engineer, Quality Assurance Engineering, or Quality Validation Consultant working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device)
- Must have experience with equipment qualification, software validation, test method validation, and/or process validation
- Must understand the Validation and Technology Transfer process and have experience with writing procedures/ reports and execution of laboratory test
- Must be able to problem solve and effectively troubleshoot issues
- Must work well with others and understand how to be successful in a Team environment
- Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated
- Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills
- Experience working with radiopharmaceuticals is a plus
- Ability to see, hear, write (English), and speak (English) clearly in order to communicate in manufacturing setting - required
23
Senior Scenario Validation Analyst Resume Examples & Samples
- Validate the design, performance, and controls of Ally's fraud defense and anti-money laundering (AML) scenarios
- Identify risks and provide recommendations that improve strategies' alignment with business goals
- Document and present findings to model validation leaders
- Develop procedures for validation of code changes and tuning events
- Develop and maintain effective partnerships with participants / stakeholders within Ally's model risk management community
- 2+ years in fraud detection and defense or AML in the financial services industry
24
Data Validation Analyst Resume Examples & Samples
- The Data Validation Analyst analyzes and validates loan approval data for commercial and consumer loans in all markets
- Uses knowledge of underwriting principals and the end-to-end loan process to review, analyze and interpret information in the Recap. Translates the information into what is required to be captured in the system of record
- Ensures compliance with established service objectives in accordance with procedures, corporate policies, legal guidelines, credit and lending policies, and applicable Federal and State Laws
- Gathers and enters into the system of record required data that is not included in the RECAP from various internal and external sources. Engages, interacts and/or consults with peers, other LTS departments, credit administration, relationship managers, legal counsel, customers and vendors
- Initiates direct communication, verbally and in writing, with credit support, relationship managers, internal and external legal counsel, customers, vendors, etc. to collect, validate and enter, into the system the required information to document, board and provide accurate reporting on Commercial/Consumer loans
- Maintains relationships and effectively encourages collaboration to provide quality customer service working diligently to meet internal and external deadlines
- Develops knowledge and understanding of support and loan documents required for the borrowing entity, collateral type and loan controls and/or covenants contained in the credit approval for various Commercial and Consumer loans
- Gathers and ensures accuracy of final documentation post-closing
- Understands and maintains knowledge of legal and regulatory issues to assess degree of risk in information obtained for various Commercial and Consumer loans
- Ensures all key operational metrics, particularly in the areas of service quality, productivity and overall efficiency are met
25
IRE Validation Analyst Resume Examples & Samples
- Provide appeals support by reviewing, researching, investigating, and auditing Part C and or D appeal cases
- Review approve/deny Maximus Packet after audit review conducted and ensure the packets are of high quality before sending to the Independent Review Entity (IRE)
- Work with Business Partners to research/resolve/update issues
- Create Case files for Dismissal Case File Requests from the Independent Review Entity (IRE)
- Document applicable systems and update Adobe PDF documents
- Analyze and identify trends and provide feedback
- Contact IRE Liaison as needed
- Assist with IRE inquires and provide high quality responses in a timely manner
- Assist with other IRE projects as assigned
- 2+ years of experience analyzing and solving Medicare beneficiary and/or provider issues in an office setting environment
- 2+ years of experience with computer and Windows PC applications (this includes the ability to learn new and complex computer system applications)
- Fully proficient with all HIPPA guidelines
- Flexible to work overtime as business needs require
- Experience with Medicare and Retirement Part C and or D plans
- Ability to multi-task, and prioritize work assignments
- Ability to understand multiple products and multiple levels of benefits within each product
26
QC Validation Analyst Resume Examples & Samples
- General analytical instrument qualification and software validation
- Software database management
- Basic scripts
- Documentation and report writing
- Demonstrable experience in data management and script writing
- A good understanding of analytical instrumentation
- Dedicated and motivated
- A team player - contributing to the objectives of the team
27
Comp Software Validation Analyst Resume Examples & Samples
- 2 years’ experience with S1000D tagging, business rules, IETM publishing with LiveContent, and providing over the shoulder S1000D training
- 5 years with a Bachelors in Science. In lieu of formal education, 8 years’ experience with TMSS SGML, Contenta, XPP, Arbortext and Part Number Database may be considered
- Possess a current or recent (w/in 90 days) Common Access Card (CAC) and the ability to maintain
- Demonstrated organizational skills and strong verbal/written communication skills are essential
- Experience resolving S1000D validation and publication errors
- Experience troubleshooting and testing software issues
- User training experience for S1000D tagging and Contenta CMS
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Validation Analyst Resume Examples & Samples
- Support order-based activity by reviewing customer prints and specifications to validate the company’s product meets all customer requirements
- Responsible to perform the “Product Review” task during Contract Validation (CV), and to identify exceptions or discrepancies to customer requirements
- Support “Issues Resolved” task by coordinating the necessary resources and reviews to resolve exceptions in a timely manner prior to order acknowledgement
- Work together with Sales, Customer Service, and Customer Engineering teams to resolve CV workflow issues or roadblocks
- CV analyst would be responsible for reviewing orders of either existing products or revisions to existing products
- AA or BA in work related experience, preferably Aerospace industry
- 3-5 years of experience with a software for PDM-product data management, preferably TeamCenter
- Understanding of CV process, metrics, and roles & responsibilities, working knowledge of TeamCenter CV workflow
- Ability review engineering prints and specifications and familiarity with Aerospace products and specifications
- Working knowledge of TeamCenter product data management system
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Successfactors Data Validation Analyst Resume Examples & Samples
- Must have PeopleSoft and Oracle experience
- Must have Experience with Microsoft Access
- Must have a previous SuccessFactors experience
- Experience and understanding of PeopleSoft systems and the use of the Oracle data tables for reporting and analysis
- PeopleSoft HR is a plus
- MS Access for import and export file, create, modify and execute queries. Use ODBC connectivity to connect with Oracle data sources
- Excel skills for imports, exports, pivot analysis which includes very large files
- Experience with SuccessFactors including the data objects, reporting tools, load error report analysis and data administration
30
Comp Software Validation Analyst Resume Examples & Samples
- 9 years with a Bachelors in Science. In lieu of formal education, 13 total years comprised of the following experience will be considered
- 10 years’ experience with Technical Manual Specification and Standards (TMSS), Standard Generalized Markup Language (SGML), Illustrated Parts Breakdown (IPB), XML Professional Publisher (XPP) Arobortext Editor
- 10 years’ analyzing S1000D requirements
- 10 years’ S1000D editing and publication with Extensible Markup Language (XML)
- 10 years’ experience with S1000D Business Rules
- 4 years’ experience with S1000D data management and publishing using SDL S1000D Contenta and Live Content
- Possess a current or recent (90 day) Common Access Card (CAC) and the ability to maintain
- Excellent organizational skills and strong verbal/written communication skills are essential
- Experience administering training for S1000D, IETM publishing, Applicability implementation and management, and content management with the CSDB
- Troubleshooting experience with S1000D editing, data management and IETM publishing issues
31
CS Validation Analyst Resume Examples & Samples
- Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in validation
- Coordinate, assist and document validation activities; preparation/approval of protocols and reports
- Draft, review and approve local validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation. Examples include SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls
- Prepare, assist, or participate in system design, specification development, and design review
- Perform systems FDA validation for SAP and customizations
- Perform revalidation and change control validation related activities
- Ability to apply complex system validation principles to work assignments
- Must be able to function independently, play a leadership role within a cross-functional team and address a variety of moderate to complex problems
- Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change
- Provide training to colleagues and contractors on our approach to systems implementation and validation SOP’s
- Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering, business owners
- Develop and maintain Validation SOPs, forms, documentation and files
- Coordinate meetings, document issues, action items, meeting notes, do appropriate follow up related to CSV projects. Recommend enhancements to project specs
- Coordinates fulfillment of all requirements for systems audits
- Project Management and mentorship of junior-level analysts
- Bachelor’s degree in computer science, technology or related field required
- At least five years experience in experience in the validation of computer systems, manufacturing, packaging, equipment and process, as well as utilities, and facilities qualification
- Must have thorough understanding of FDA regulations and computer validation guidance documents
- FDA Compliance experience required
- Experience in thorough testing of applications, computerized systems, changes and implementations
- Familiarity with the following systems: MES, SAP, ERP, Document Management, HP Quality Center and Quality Records Management
- Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA
- Computer knowledge of 21 CFR Part 11, CFR 820Excellent communication skills and customer service orientation
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Encounter Validation Analyst Resume Examples & Samples
- Strong 837, 277, or 999 experience required
- Background in claims, root cause analysis and / or health care data highly preferred
- Strong organizational skills including the ability to manage tasks with competing priorities
- Familiarity with SQL along with other HIPAA transactions and code sets helpful
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Encounter Validation Analyst Resume Examples & Samples
- Technical savvy, strong computer knowledge including experience in Excel is needed!
- Experience in working with large data files in Excel is a huge plus!
- Familiarity with SQL would be helpful
- Knowledge of 837 institutional and professional file structure is a plus
- Background in claims, root cause analysis and / or health care is a plus!
- Strong critical thinking skills are needed
- Strong analytical skills are needed
- Strong communication skills are needed
- Strong problem solving skills are needed
- Knowledge of all Microsoft office including Outlook is important
34
Validation Analyst Resume Examples & Samples
- 4+ years experience must include the following
- 2+ years software testing
- 2+ years software development experience
- 1+ years experience with testing automation tools
35
Validation Analyst Resume Examples & Samples
- Independent validation of the Internal Model, for both business and regulatory purposes, along with the production of Validation Reports, performed at a Group level and as required to support each XL Catlin legal entity
- Develop and maintain a robust validation policy and framework, that independently reviews the accuracy and appropriateness of the Internal Model
- The team also supports
- Taking ownership of the construction and maintenance of particular validation tools or summary models
- Running validation tests, producing validation output summaries and assisting in the interpretation of test conclusions
- Assisting in analysis of unexpected validation results and helping to suggest appropriate future courses of action
- Assisting in the production of validation reports throughout the year
- Assisting in developing and maintaining a robust technical validation framework
- Assisting in the validation of model changes implemented by the Capital Modelling Team
- The individual will be expected to be flexible in their work ethic. This might involve switching from one project to another as priorities change, changing study days or working later than planned
- In addition to the key accountabilities above, you may be required to undertake other duties from time to time as the Company may reasonably require
- Bachelor's degree from college or university in mathematics or related field
- Part qualified actuary with at least 2 years of relevant actuarial work experience is advantageous, but not essential. A suitable technical background in another risk management discipline will be considered
- Excellent attention to detail and a meticulous eye for identifying inconsistencies or inaccuracies in data entry or data outputs
- Ability to establish and follow robust, logical and auditable processes to complete a task or project
- Able to organise self (and others if applicable) including effective scheduling, prioritisation and time management skills, completing tasks to tight deadlines. Demonstrates a ‘can do’ attitude
- Comfortable taking ownership for own work, identifying the need for action (using initiative) whilst working effectively within a team
- Excellent computer skills including experience with Microsoft Excel, Microsoft Powerpoint and Microsoft Word
- Knowledge of the Igloo modelling software platform
- Demonstrable evidence of interpreting & manipulating data clearly and accurately with the ability to extract & clearly articulate key points
- Demonstrates excellent communication skills, a confident and articulate presenter to internal/external audiences, exercising appropriate discretion in dealing with people from all levels of the Company
- Ability to build effective working relationships (internally/externally), establishing credibility amongst a wide and demanding client group (if applicable)
- Displays a resilient and adaptable style, track record of remaining calm in demanding circumstances, adjusting comfortably to changing conditions / priorities
- The role would suit highly driven self-starters, with a strong desire to challenge and deliver
- Solid understanding of the insurance business environment, risk management operations and underwriting together with Solvency II exposure
- Business acumen – demonstrates sound intuitive judgment
36
Associate Validation Analyst Resume Examples & Samples
- Serves as Validation Support for new releases and modifications to applications throughout the Software Development Life Cycle
- Prepares Validation Plans, Test Cases and Validation Summary Reports and executes Test Cases
- Reviews and approves all change controls associated with the validated systems per SOP
- Reviews PQ and change control documentation with the IT Project Manager per SOP
- Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer. Updates test scripts where required based on requirement changes or upgrades in application functionality
- Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably proving the software functions correctly
- Creates, updates, and manages data within the testing environment, sufficient to accurately test software functionality
- Provides ongoing business support to users during the implementation and continued use of validated platforms, ensuring that appropriate training, support and maintenance is provided
- BS degree in computer science, lab sciences ( chemistry, biology or similar) or life sciences or related area, or equivalent combination of education, training and professional experience that provides the required knowledge, skills and abilities
- With 1+ year of relative experience in validation, lab operations or similar role
- Ability to perform detailed processes and procedures
- Previous experience with systems or software testing, analysis or review a plus
- Client focused service approach with strong interpersonal skills
- Ability to collaborate well with others and support deadline driven goals and projects
- Knowledge of Assist and or Connexions a plus
37
Encounter Data Validation Analyst Resume Examples & Samples
- Participate in the development, data collection and review, and timely completion of data validation studies, operational reviews, quarterly encounter logs and ad hoc audits
- Design, formulate and evaluate spreadsheets used to analyze and track encounter quality
- Recommend changes as to the workability and efficiency of health plan encounter data reporting practices and procedures. Evaluate corrective actions and advise management on possible courses of action
- Respond to technical inquiries from Contractor personnel
- Participate in the development and facilitation of encounter/data validation related training workshops for external and internal stakeholders
- Participate in the development and maintenance of data validation desk-top procedures and technical documents
- Proficient in analyzing complex problems and drawing logical conclusions based on information from several sources, including contractor
- Demonstrated experience with Claims/Encounter processing, concepts and healthcare industry practices
- Demonstrated experience communicating effectively when interacting with internal/external stakeholders in a variety of settings, including Contractors
- Demonstrated experience when using appropriate techniques for the analysis of encounter information
- Strong effective communication with all levels, both written and verbally with excellent interpersonal skills
- Proficient with Claims/Encounter processing, concepts and industry practices
- 1-2 years of experience working in a managed care environment
- 3-4 years of experience performing operational and/or program specific analyses
- 1-2 years of Community College/Vocational School Program in related field in nursing or medical record technology
38
Validation Analyst Resume Examples & Samples
- Active role in the execution of software verification and validation protocols/test cases for Informatics Solutions as required by the Quality Management System
- Recommend technical solutions and process improvements related to products
- Interface with related quality, R&D, Professional Services, Product Management and Commercial Organization. Participate in the design and development of black-box tests (i.e. tests based on normal use of the product being tested) and white-box tests (i.e. tests that may require use of development tools such as the STARLIMS Designer to initiate their execution)
- Interpret the results of those tests
- Identify and recommend subsets of existing test scripts for regression testing based on risk assessments (e.g. when a product is being re-released with a different configuration)
- Work is evaluated for soundness of judgment, compliance and overall quality and efficiency
- Supervise and mentor junior testers during the execution of product tests for validation and verification
- Generate and update test scripts based on user and functional requirements by determining expected results and identify coverage gaps including negative tests with emphasis on workflow scripts and technical test scripts
- Confer with personnel to analyze operational procedures identify problems and learn specific requirements per Abbott Informatics QMS. Evaluate the product beyond predefined test scripts consider end-user needs and recommend new features/enhancements
- Monitor and report on the progress of test executions
- Isolate defects in the software and report them in the quality tracking system. Interact with developers to help issue resolution
- Create methodologies for providing software testing support for the company’s products and assist in implementing these methodologies
- Write release documents such as release notes test plans and verification summary reports
- Report and investigate CAPAs by probing for root causes of problems, collaborate to find mutually beneficial solutions and propose actions or steps and assists through implementation
- Support the writing team in development of end-user training methods and documentation to promote and enhance the company's sales service and profitability
39
Software Validation Analyst, Intermediate Resume Examples & Samples
- Prepares Test Procedures in accordance with test plans
- Investigates test anomalies through analysis of data files, design documentation and interaction with development departments
- Prepares problem reports in the defect tracking system describing test failures and defects
- Develop test cases including operational and stress-test (bust-it) scenarios
- B.A.Sc in Electrical Engineering, Computer Engineering, Systems Engineering or equivalent
- Computer literacy including word processing, spreadsheet, and databases is essential. Computer literacy using special application software such as problem tracking, requirement management and parsing software is a significant asset
- Understands basic engineering management practices for project planning and scheduling
- Experience in task planning, including estimation, performance tracking and reporting
- Develop familiarity in the operation, design, and installation of delivered product as well as expertise in specific functionality
40
Spreadsheet Validation Analyst Resume Examples & Samples
- Review QATS for computational accuracy, functional propriety and control environment effectiveness
- Create high quality QATS validation reports that are consistently clear, factually accurate and concise
- Source relevant data from currently defined datasets and enterprise data warehouses to develop datasets for QATS validation analysis and reporting
- Build repeatable and auditable processes that support the generation of datasets, reports and analysis
- Answer ad hoc QATS validation analysis requests from Model Governance and other internal partners
- Work collaboratively with Line of Business, Risk and other matrix teams to identify opportunities for improving Model Risk Management analysis, modeling, reporting and monitoring
- Support the Model Validation Director in publishing reports and analyses to all constituencies
- Investigate reporting anomalies
- Interact with IT and other matrix partners to improve Model Risk Management and QATS validation capabilities
- Consistently push for reporting efficiency gains through use of technology driven automation and well-designed and documented processes
- Develop value added risk identification and quantification analysis and reporting
- Develop risk management presentation materials
- 2 years' experience in banking or financial services. Experience in a risk or line of business function preferred
- Advanced knowledge of Microsoft Office Excel, Word and Access. Knowledge of VBA or SAS preferred
- Data management and documentation skills and orientation to accuracy and details
- Excellent analytical skills and reasoning ability with the ability to develop and execute strategic and tactical plans
- Excellent written and verbal communication skills. Excellent technical writing skills
- Ability to think thoroughly within end-to-end processes to see downstream and upstream impacts
41
Senior Validation Analyst Resume Examples & Samples
- Tracking all software versions, features, bugs and validation efforts for all software created and/or modified by the Development teams
- Developing and utilizing test data sets that support the implementation of test plans and procedures
- Creating and executing manual test scripts which includes testing software applications for quality and functionality using defined validation protocol and testing techniques
- Creating associated validation documentation using defined documentation methods
- Writing comprehensive test plans and reports which set strategy and summarize results
- Working with application developers in resolving issues and retesting applications
- Partnering with technical and business teams to achieve understanding of current and future functionality
- Accurately assessing the risks associated with each design solution / project
- Exceling at business negotiation, ability to interact with clients, team members, various levels of management and external groups
- Attending and participating in applicable company-sponsored training
- Knowledge of Azure preferred
- Knowledge of cloud based testing preferred
- Ability to work in group setting and independently; ability to adjust to changing priorities
- Excellent attention to detail and orientation toward careful meticulous work
- Fluent in reading, writing and speaking English
- Strong documentation and organizational skills
- Ability to maintain professional and positive attitude
- 5+ years experience in validation/software testing required
- Experience working with computer software including Word, Excel and SQL preferred
- 2+ years experience working with clinical trials and/or within pharmaceutical environment required
- Working knowledge of the drug development process including knowledge of FDA requirements for GxPs and 21 CFR Part 11 required
- Knowledge of software development tools required, .NET, JAVA preferred
- Proven ability in problem solving and troubleshooting
- Proven mentoring and/or supervisory skills required
42
Clinical Validation Analyst Resume Examples & Samples
- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
- Travel (approximately 0%) domestic and/or international
- Performs validation/testing activities according to relevant ICON/Sponsor SOP’s and appropriate regulations
- Reviews Data Validation 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
- Reviews Listing Validation Specification document created by study team
- Validates listing outputs as per the study/sponsor requirements
- Maintains and completes study documentation in a timely manner following ICON or Sponsor procedures, as applicable
- 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
- Completes assigned tasks within budget and timeline constraints and reports any quality issues to lead or manager in a timely manner
- Attends sponsor audits and assists with in-progress audits, as needed
- Participates in and contributes to internal user group meetings to share knowledge and provides latest update/features. Participates in Data Management department initiatives
43
Independent Verification & Validation Analyst Resume Examples & Samples
- Providing IT System Technical Support, including
- IT Infrastructure Library (ITIL) certified or trained (if applicable) in their stated field; i.e., Release and Control Practitioner and or ITIL v3 Certification
- Certifications/experience in areas such as: Project Management, Capability Maturity Module Integration, and other software and software engineering certifications are a plus
44
Encounter Validation Analyst Resume Examples & Samples
- 1+ years of data interpretation and analysis experience. Extensive experience with databases as well interpretation and manipulation of related data
- Healthcare background. Strong organizational skills
- Working knowledge of Microsoft Office products (Word, Excel, PowerPoint, Outlook)
45
IRE Validation Analyst Resume Examples & Samples
- Review approve / deny Maximus Packet after audit review conducted and ensure the packets are of high quality before sending to the Independent Review Entity (IRE)
- Work with Business Partners to research / resolve / update issues
- 2+ years of experience analyzing and solving Medicare beneficiary and / or provider issues in an office setting environment
- Appeals experience with Medicare and Retirement Part C plans
46
Clinical / Validation Analyst Resume Examples & Samples
- This Clinical/Validation Analyst will gather, analyze and validate the business requirements of project stakeholders
- Elicit requirements through facilitated requirements gathering sessions
- Analyze requirements and create specifications
- Validate requirements to meet the needs of the business
- Perform system testing to validate the high-level functionality of solutions
- Build subject matter expertise in customer’s field and develop productive relationships with customers
- Extensive IT experience in Computer System Validation by ensuring compliance with FDA Regulations
- Expertise in authoring and reviewing documents related to Computer System Validation Lifecycle (CSV) such as – Validation Plan (VP), User and Functional Requirement Specification, Installation Qualification (IQ) and User acceptance testing plan (OQ, PQ), Test scripts, Test, and Validation summary reports
- Experience in validation of clinical and research and development systems
- Experience in Drafting, Reviewing and Updating various governing documents such as Standard Operating Procedures (SOP’s), Training Plan/Manuals and User Manuals
- Comprehensive knowledge of 21 CFR Part 11, GxP related compliance requirements and working knowledge of GAMP methodologies
- Proficient at problem identification and resolution, defining and managing business requirements
- Experience in producing various work products throughout the analysis and design phases of a project
- Knowledge and application of industry standard project management principles delivered using various systems development life cycle
- Educational Qualifications
- BA/BS degree in Business, Computer Science or related field
- 5+years direct work experience as a business analyst with BA certification desirable
47
Associate Validation Analyst Resume Examples & Samples
- Active role in the execution of software verification and validation protocols/test cases for Informatics Solutions as required by the Quality Management System
- Recommend technical solutions and process improvements related to products
- Interface with related quality, R&D, Professional Services, Product Management and Commercial Organization. Participate in the design and development of black-box tests (i.e. tests based on normal use of the product being tested) and white-box tests (i.e. tests that may require use of development tools such as the STARLIMS Designer to initiate their execution)
- Interpret the results of those tests
- Identify and recommend subsets of existing test scripts for regression testing based on risk assessments (e.g. when a product is being re-released with a different configuration)
- Work is evaluated for soundness of judgment, compliance and overall quality and efficiency
- Generate and update test scripts based on user and functional requirements by determining expected results and identify coverage gaps including negative tests with emphasis on workflow scripts and technical test scripts
- Confer with personnel to analyze operational procedures identify problems and learn specific requirements per Abbott Informatics QMS. Evaluate the product beyond predefined test scripts consider end-user needs and recommend new features/enhancements
- Monitor and report on the progress of test executions
- Isolate defects in the software and report them in the quality tracking system. Interact with developers to help issue resolution
- Write release documents such as release notes test plans and verification summary reports
- Report and investigate CAPAs by probing for root causes of problems, collaborate to find mutually beneficial solutions and propose actions or steps and assists through implementation
- Support in the technical writing and in the development of end-user training methods and documentation to promote and enhance the company's sales service and profitability
48
Computer System Validation Analyst Big Data Resume Examples & Samples
- Understand the GxP critical systems used within MSD and how enhancements to those applications can contribute to continuous improvement of quality management operations across the company
- Planning, execution and coordination of IT systems validation activities
- Creation of validation documentation
- Support and maintain Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with current GMP expectations and established agency requirement and guidelines
- Align the agile development techniques and practices with current regulatory expectations
- Education: MSC. Degree or BSc. Degree in Life Sciences, Information Technology or other relevant fields
- Ability to analyse quality management operations from a data and systems perspective and identify appropriate process and technological improvements
- Ability to work both independently and collaboratively
- Working/university experience in Pharmaceutical, medical device or other regulated industry
49
Computer System Validation Analyst Resume Examples & Samples
- Minimum 3 years of experience with Computer System Validation
- Strong problem-solving, analytical and process improvement skills
- Demonstrated ability to proactively identify issues and either resolve or escalate to the appropriate level for resolution
- Experience with process improvement
- Previous experience operating in a GxP work environment
- Curiosity about business and IT processes
- Working knowledge of IT applications utilized within Indy Dry Product manufacturing
- Knowledge of Indy Dry Product manufacturing
- Working knowledge of MQIT CSV practices, including system periodic reviews, external/internal audits
50
Senior Concept Validation Analyst Resume Examples & Samples
- Define key hypotheses to test, structuring the experimentation plan, and building test stimuli globally
- Leverage current methodologies and concepts to design concept validation plans, from end to end. Develop research methodology for proving/disproving hypotheses. Analyze, interpret, and present key results and recommendations to senior leadership
- Formulate a point of view on competitive advantages by performing secondary research on competitive landscape for new innovation ideas globally
- Conduct interviews with internal/external experts and consumers to assess unfair advantages, identify additional questions to test, and verify market sizing assumptions. Write discussion guides to inform interviews
- Develops quantitative models to estimate size of opportunities, leveraging creative solutions to arrive at market size. May conduct long-term trend and market analysis for future opportunities
- Develop go/no-go recommendations based on data to inform next steps within innovation
- Assists with and may create new techniques and approaches to expand the Concept Validation capability
- Spearhead expansion of global concept validation by working closely with broader, international network of SBU/Dept. countries
- Mentor more junior team members
- Experienced in Design Thinking, Innovation, or consumer research
- Able to synthesize facts to craft a story. Proficient in Excel, PowerPoint, and analysis
- Creative thinker, intellectually curious, able to think outside the box, and interested in emerging technologies and innovation trends
- Positive attitude, willingness to operate in a start-up environment and wear multiple hats
- Solid organization, communication and presentation skills
- Highly collaborative and strong interpersonal skills, with proven success in influencing others
- Bachelor's degree in business, economics, innovation or similar field
- Minimum of 5-7 years of relevant experience
51
Ccar Validation Analyst Resume Examples & Samples
- Bachelor's degree in a quantitative field, and five to eight years of experience in statistical modeling OR
- Master's or PhD degree in a quantitative field, and less than five years of experience in statistical modeling
- Excellent knowledge in statistics, mathematics, and financial modeling
- Experience in CCAR stress testing model development or validation
52
Product Validation Analyst Resume Examples & Samples
- Responsible for the problem analysis, development testing, maintenance and execution of developments, verifications and checks using NAVSTREETS or any other geo format
- Responsible for the Go/No Go decision for Europe (E/W) and MEA Data- and Distribution Product Products or their components submitted for 1 of the validation procedures/gates
- Create and execute test programs for Master acceptance and integration test support to car manufacturers
53
Data Validation Analyst Resume Examples & Samples
- Collect, evaluate and validate business data through internet based research
- Validation of data as appropriate, in line with our Operational Manual
- Creates and maintains full and comprehensive audit trails of corroborative sources for all records
- Follow company process and procedure methods for the evaluation of data as per Operational Manual
- Has a strong understanding of the Managed Data Service workflow and process
- Collects, analyses, interprets, and summarises data in preparation for generation of client reports
- Maintains computerised collection and tracking of relevant data through a comprehensive audit trail of corroborative sources
- Achieve pre-defined performance targets in order to satisfy client demand
- Key Relationships
- Reports to the Validation Team Manager on a daily basis
- Skilled in the use of personal computers and related software applications
- Attention to detail and accuracy
- Adaptable to change
- Professional in attitude and appearance
- Ability to work on your own initiative and as a team member
- Knowledge of internet research methodology, principles and procedures
- Foreign language skills
54
Validation Analyst Resume Examples & Samples
- Review QATs for computational accuracy, functional propriety and control environment effectiveness
- Create high quality QAT validation reports that are consistently clear, factually accurate and concise
- Answer ad hoc QAT validation analysis requests from Model Governance and other internal partners
- Source relevant data from currently defined datasets and enterprise data warehouses to develop datasets for QAT validation analysis and reporting (when applicable)
- Business related Bachelor's degree
- Advanced knowledge of Microsoft Office Excel, Word and Access, with VBA or SAS experience preferred
- Strong analytical, technical writing and verbal communication skills
- Strong project management skills (e.g. highly detail-oriented, deadline driven, self-directed, organized)
- Ability to multi-task and work well in a changing environment
- Excellent interpersonal skills to work effectively with a diverse team
