Validation Analyst

Summarized Purpose:

Provides basic business/system support of software systems and/or laboratory instrumentation. Works with staff of various departments to initiate and complete performance qualification (PQ) validation. Facilitates the validation process and implementation of system upgrades, including guiding, testing, supporting the introduction and ongoing support of software systems.

Essential Functions

• Participates as a validation representative at project team meetings and completes assigned action items. Provides direction for future releases to software systems; reviews change requests. Communicates proactively with all project team members and provides regular feedback to management concerning timeline/budget or resource constraints.
• Provides validation support for new releases and modifications to applications throughout the software development life cycle. Prepares validation plans, test cases and supporting validation documentation and executes test cases.
• Reviews PQ and change control documentation with leadership per SOP.
• Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer.
• Assists in the execution of test scripts 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. Works with leadership to address any PQ related issues arising from client or internal audits.
• Manages assignments to meet deadlines and produce high quality deliverables. Remains familiar with relevant 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 and/or instrumentation.

Job Complexity

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

Job Knowledge

Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

Supervision Received

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 Relationships

Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters. Builds productive internal / external working relationships.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Client-focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others
• Strong attention to details and problem-solving skills
• Demonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum of instruction
• Positive attitude, enthusiasm toward work, and the ability to work well with others
• Effective organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines
• Solid understanding of clinical trials 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 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. Ability to assess the cause of test failures
• Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team

Management Role:

No management responsibility

Working Conditions and Environment:

Work is performed in an office environment with exposure to electrical office equipment

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• 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.
• Frequently interacts with others to obtain or relate information to diverse groups.
• 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.
• 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.
• Regular and consistent attendance.

Percent Billable : 0% - 20%