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Validation Analyst - 2700
at Carter BloodCare
Under the supervision of the Manager of IS Compliance, the Validation Analyst evaluates business and compliance risks related to software development, application upgrades, and systems modifications in a blood banking environment; performs risk analysis and determines the level of validation required and develops testing and validation plans; develops test cases, performs testing, validation, and verifications; documents errors, deviations and defects, compiles data and prepares validation summaries for management review.
Perform structural and functional testing of new/revised applications. Frequently acts as a liaison between users and software engineers, develops software requirements and specifications documents, participates in iterative development providing quality assurance oversight, and at times assumes the role of project manager or coordinator to manage project. Maintains validation documentation, version control, and performs data and configuration management. Frequently is required to assist with the development of user guides and manuals. Follow quality standards, Standard Operating Procedures (SOP), and internal guides to ensure compliance.
In coordination with users, resolve computer issues related to blood product quality and product release or donor eligibility. The position requires superior communication and people skills working with all levels within the organization, as well as blood donors, hospital staff, external developers and visitors. Regular full-time attendance is essential, especially during regular office hours.
- Some college is required
- Bachelor’s degree, especially in medical technology, SBB certification, or quality assurance diplomas, is preferred.
- 3-4 years of experience in an IT or healthcare field including validation, writing, and documentation. Blood Bank or other regulated industry experience preferred.
SKILLS AND KNOWLEDGE
- Ability to concentrate on complex projects
- Excellent oral and written communication skills
- Excellent analytical ability.
- Ability to deal with technical staff as well as users.
- Knowledge of software validation background is desirable.
Carter Bloodcare is an EEO/Affirmative Action employer. Carter Bloodcare provides equal employment opportunities (EEO) to all employees and applicants and will not discriminate in its employment practices due to an employee’s or applicant’s race, color, religion, sex, sexual orientation, gender identity, age, national origin, genetic, and veteran or disability status. In addition to federal law requirements, Carter BloodCare complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. Carter Bloodcare is a Pro Disabled & Veteran Employer.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.