Software Validation Manager

At Trinity IT Services, we specialize in recruiting top talent for organizations across many industry verticals. With our extensive network and expertise in recruitment, we are dedicated to helping individuals like yourself find rewarding opportunities that align with your skills and career aspirations. Trinity is proud to be partnering with ARC-One Solutions for the recruitment of their full-time IT career opportunities. ARC-One Solutions is creating a next-generation Blood Establishment Computer Software (BECS) platform along with an extensive series of materials designed to provide their partners with robust software that is simple to implement and supports safe, efficient, and compliant regulated blood supply chain management. ARC-One Solutions was created in April 2020 through a partnership between two of the largest blood centers in the country, the American Red Cross and OneBlood. ARC-One Solutions has the privilege and responsibility to assist these organizations in fulfilling over 50% of the nation’s blood supply needs. Once implemented, their software will process approximately 10 million products across 56 states and territories. We are currently recruiting for a Software Validation Manager at ARC-One Solutions. The base salary range for this position is $94,000 - $165,000 as a full-time W2 employee of ARC-One Solutions. Actual pay will be determined based upon a candidate's job-related knowledge, skills, education, experience, geographic location, and may include other job-related factors such as certification(s), professional licensure, or internal equity considerations.

OverviewManages a team assigned to validate software. Responsible for establishing and maintaining continual improvement of systems that impact R&D and commercial operations of the organization. Collaborates with customers, business, and development teams to analyze business requirements to identify risk and ensure test cases are built to fully validate software.

ResponsibilitiesThe list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.· Leads software validation efforts by implementing and managing projects; provides leadership and guidance to team members· Selects and utilizes tools and methodologies to ensure that the quality of deliverables meets expected standards· Maintains system documentation and process diagrams according to company standards and in compliance with regulatory requirements· Works with process owners to understand the intent of software functionality of integrated business processes for the Blood Establishment Computer Software (BECS) system· Provides technical training to team members, including but not limited to creating a logical breakdown of test cases based on risk assessment· Develops comprehensive software validation protocols in alignment with the Agile framework used by Design and Development teams· Designs and maintains script templates and discrepancy tracking logs; resolves discrepancies and writes validation summaries· Coordinates with automated script development to create seed data and test run executions as well as manual regression and end-to-end test planning· Oversees creation of validation script writing, execution and approval· Creates and monitors reports for departmental key performance indicators, tracking and trending.

QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or ExperienceBachelor’s degree from a four-year college or university and five (5) years blood banking experience, quality experience preferred; or equivalent combination of education, training and/or experience. A minimum of three (3) years of experience as a leader, managing high performing teams preferred.

Certificates, Licenses, Registrations and DesignationsMedical Technology License, preferred

Knowledge, Skills and Abilities• Knowledge of performing validation of BECS Software and Standard Operating Procedures• Knowledge of risk/hazard analysis of business requirements leveraging GAMP 5• Knowledge of FDA and international medical device regulations• Knowledge in working with current issue and effect management software• Knowledge and understanding of applicable Regulated Software Application (RSA) modules preferred• Ability to think critically and prepare Seed Data required for use in executing Test Cases and associated Test Runs• Ability to read, analyze, and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, governmental regulations• Ability to write reports, correspondence, and procedure manuals according to CGMP (Current Good Manufacturing Practices) standards• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work• Ability to analyze and document complex business processes• Ability to multitask and remain flexible when priorities or work direction change• Strong analytical and problem-solving skills• Ability to explain technical concepts in non-technical terms to customers and staff• Knowledge in creating detailed test cases/scripts based on business and functional requirements, as well as reviewing the same• Knowledge of software development life cycle principles and quality assurance methodology• Ability to meet deadlines and focus on critical projects• Ability to lead others to meet goals and objectives.