Validation Analyst

reflect cost, time and alternative actions to satisfy existing and future needs of the corporation. Tests and evaluates plans and protocols for of system performance. Conducts analysis of systems specifications and uses the latest analysis/diagramming tools to represent business/technical processes. Develops conversion and system implementation plans. Prepares and obtains approval of system and
programming documentation. Recommends changes in development, maintenance and system standards. Coordinates system upgrade activity.
- Participates as a validation representative at project team meetings and completes assigned action items.
- Prepares validation plans, test cases and validation summary reports, and executes test cases.
- Reviews and approves all change controls associated with validated systems per SOP. Reviews PQ and change control documentation with leadership per SOP.
- 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 sufficient data within the testing environment to accurately test software functionality.
- Manages assignments to meet deadlines and produce high quality deliverables.
- Works with leadership to address any validation issues arising from client or internal audits.
- Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs.
- Participates in the identification of user requirements and system design and assists in the preparation and review of system documentation such as requirements and design specifications for software systems
- Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
- Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Business Contacts are internal to the company and with external customer/vendor contact on routine matters. Builds productive internal / external working relationships.

Qualifications:

- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Knowledge, Skills and Abilities:

- Client-focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others
- Demonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum of instruction
- Strong attention to details and problem-solving skills
- Effective organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines
- Positive attitude, enthusiasm toward work, and the ability to work well with others
- Solid understanding of life sciences operational processes and terminology and solid understanding of the software development life cycle (SDLC)
- Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced
- Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans.
- Ability to assess the cause of test failures
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
- Requires multiple periods of intense concentration.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask.
- Hours vary based on project deliverables. May be early in the morning or later at night.
- Regular and consistent attendance.