The QA SW Validation/Metrics Specialist is responsible for ensuring computer systems remain in a validated state and acts as the subject matter expert for validation related matters. The specialist is also responsible for the tracking and analysis of data for key quality indicators.
Duties and Responsibilities
• Generates, executes and reviews SW validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• Prepare materials and resources needed for the execution of qualification/validation studies according to approved protocols and OPs.
• Contributes to the system design and modification process for donor center and corporate automated systems and ensures that senior management is aware of known limitations of the system.
• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
• Investigates and troubleshoots problems that occur and determines solutions or recommendations for changes and/or improvements.
• Coordinates with other departments to complete validation tasks.
• Assesses validation documentation for completeness and accuracy.
• Track, evaluate Quality Metrics (QM) and Key Performance Indicators (KPI) to identify trends at the Donor Center and Corporate level
• Provide trend reports for both Donor Center and Corporate
• Medical, Dental, Vision
• Long Term Disability/ Short Term Disability
• Life Insurance
• Life Assistance Program
• 401(k) Retirement Plan
• Health Savings Accounts/Flexible Spending Accounts
• BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 1 year related experience within the SW validation field preferred; may substitute relevant experience for education.
• Ability to comprehend regulatory requirements and technical documentation.
• Ability to work independently and as part of a team. Ability to prioritize effectively, manage conflicting priorities, and adapt to changes should the situation require it.
• Ability to identify solutions to complex problems and strategically navigate challenges
• Committed drive and passion to achieve best interests for the Company.
• Ability to communicate effectively at all levels of the organization.
• Excellent people skills, which extends to a diverse group of individuals and demographics.
• Must be able to travel upon short notice.
• Travel requirements are approximately 50%.
• Professional appearance and demeanor.
• Ability to operate computer software.
• Ability to sit or stand for up to four (4) hours at a time.
• Ability to read and review documents for up to four (4) hours at a time.
• Ability to tug, lift, and pull up to fifty (50) pounds.
• Be able to bend, stoop or kneel and climb stairs and/or ladder.
• Occupational exposure to blood-borne pathogens.
• Able to travel by plane and drive car.