Summary of Major Responsibilities
The Senior QA Validation Analyst is a member of the IT Applications Quality and Compliance team and is responsible for providing QA expertise and computer systems validation support activities across Exact Sciences.
This position serves as the IT quality liaison to the Exact Sciences Operations organization for GMP-related services and support and will represent Operations quality priorities in IT strategic planning activities. The Senior QA Validation Analyst is responsible for supporting Operations' validation teams in the qualifying, maintaining, and re-qualifying certain IT assets, software, and systems and will participate in GMP project teams as the IT representative. This role will also participate in IT process improvement projects.
The Senior QA Validation Analyst interacts with cross-functional groups across Exact Sciences including Operations, Manufacturing, Quality Engineering (QE), Validation, Organizational Engineering (OE), Data Services, Enterprise Applications, Infrastructure, and IT. QA Validation Analysts are recognized as strong quality proponents, computer systems validation subject matter experts, and technical resources on project teams across the business.
Essential Duties and Responsibilities
Collaborate with cross-functional groups across IT and other areas of the business to create and maintain standard processes and procedures for both Qualified and non-Qualified IT assets, software applications, and computer systems including Change Management processes and Release Management processes. Facilitate software applications and computer systems Change Management by participating in the planning, implementation, and verification and validation of the change.
Develop and maintain quality metrics for software applications and computer systems supported by IT.
Implement standard risk and impact assessment methods and metrics for IT assets, software applications, and computer systems.
Draft and maintain local validation and compliance documents that support GMP validation, computer systems validation, and SDLC utilizing good documentation practices for IT assets, software applications, and computer systems. Examples include SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.
Develop and provide training on our SDLC and computer system validation processes and SOP's.
Support continuous process improvement efforts relating to computer systems validation and software development and change. Identify opportunities and make constructive suggestions for change to improve process effectiveness to heighten quality.
Support Validation teams across the business in the qualification, maintenance, and re-qualification of Qualified IT assets, software, and systems. Maintain inventory of Qualified IT assets, software, and systems.
Perform/Review system assessments, validation protocols, test scripts.
Ensure that validation and qualification activities are compliant and consistent with company validation policies and procedures.
Work with internal IT partners to understand infrastructure architecture and framework to ensure regulatory requirements are met.
Regularly communicate status and progress of validation/qualification activities to the Senior IT Program Manager for Applications Quality and Compliance.
Provide mentorship and assistance to other team members
Special projects as business needs require.
Ability to work in an office setting, operate telephony devices, and a computer.
Regular and reliable attendance.
Support and comply with the company's Quality Management System policies and procedures.
Bachelor's degree in health-related sciences, engineering, information technology, or another discipline with equivalent work experience.; or high school degree/general education diploma and 4 years of relevant experience in lieu of degree
8 years work experience in the biotech, biological, pharmaceutical or other FDA or GMP-regulated industry
5+ years of validation experience in computer systems validation, FDA-regulated or GMP-regulated industry
Sound understanding of Change Management, Release Management, and Quality Risk Management concepts
Experience in developing, reviewing, and executing validation and change control documents, authoring SOP's, and validation protocols (e.g., IQ, OQ, PQ)
Strong technical writing skills
Proven ability to work within a fast-paced, cross-functional team environment
Strong leadership and communication skills
Self-starter, highly organized; excellent presentation and interpersonal skills; high level of business management and facilitation skills; capability to resolve complex problems
Adaptable, open to change and able to work in ambiguous situations and respond to new information or unexpected circumstances
Authorization to work in the United States without sponsorship
Master's degree in health-related sciences, engineering, information technology, or another discipline with equivalent work experience.
Basic understanding of Quality Management System (QMS) requirements
Ability to organize and present technical information with minimal assistance
Customer focused; Action-Oriented; Building Team Spirit; Self Development; Creativity & Innovation; Problem Solving; Ethics & Values
Experience with SAP, Agile, Seeburger, ServiceNow-CMMS, Electronic Form Database (EFD) validation a plus