Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, we believe infant nutritional products should be human milk-based. As a privately held, scientifically driven company, committed to improving premature infant nutrition, we are using human milk to change the standard of care in the NICU. Prolacta operates and/or owns milk banks that provide the starting material for the products Prolacta sells.
The IT Tester is a critical role within the Prolacta Application Development team. This role will develop IT testing for all software applications, enhancements, modifications and releases as well as end user testing. Strong communication skills, systems analysis, extreme attention to detail and development experience in .NET/SQL, php/MySQL, Macros, Visual Basic are key attributes of this role. The Software QA Tester will develop and automate test cases; insure accuracy and completeness of all tests, and direct code remediation for developers. Experiences with writing test scripts for validated systems. Familiarity of GAMP 5 is a major plus.
Primary Duties and Responsibilities
• Provides traceability from business requirements and technical specifications to test conditions; reviews and approves documentation from developers.
• Creates and executes detailed test designs and conditions for unit tests, regression tests, integration tests and user acceptance tests.
• Approves test data; insure alignment with requirements
• Collect metrics to measure test progress and quality outcomes
• Tracks issues to successful resolution
• Collaborates with analysts, developers and system owners in the testing of software applications
• Works closely with the Prolacta Quality team to insure compliance with regulatory requirements
• Participates in special projects as assigned
Job Requirements and Qualifications
• Bachelor’s Degree required in Computer Science, Engineering, Business Systems, or Math
• 3+ years of experience with 21 CFR Part 11, ICH standards, EMEA, GLP, GCP, GMP, GDP regulations, GAMP Methodologies and general Software Development Standards.
• Solid understanding of IQ/OQ/PQ protocols and reports
• 3+ years’ experience with writing Testing Documents, Test Plans, and Test Scripts and reports
• 3+ years’ experience in test case design and execution
• 3+ years’ experience in data validation of SQL
• 3+ years’ experience in back-end interface testing with disparate systems
• 3+ years’ experience in testing data flows through multiple interfaces
• Proficient in testing frameworks and tools in the Microsoft .NET/SQL framework; Visual Studio/TFS, win runner/load runner
• Proficient in creating complex SQL scripts
• Proficient in test automation, Selenium and PowerShell Proficient in leveraging software tools to track requirements, test cases and defects
Other Knowledge, Skills and Abilities
• Excellent verbal and written communication skills; Ability to work effectively with individuals at all levels in the organization
• Experience in FDA regulated and/or biologic companies desired
• May work on other duties as assigned
Work Environment (Location, travel, shift, on-call, etc.)
Duarte, CA and City of Industry, CA
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.