What are the responsibilities and job description for the Validation Analyst position at American Cybersystems?
JOB REQUIREMENTS : Job Description : Summarized Purpose :
- Provides basic business / system support of software systems and / or laboratory instrumentation. Works with staff of various departments and the client 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 and approves / rejects 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 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.
- Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer.
- 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. 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 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 and / or instrumentation. 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 analyse software defects, assess the cau To view the full job description please use the link below.
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