Sr Analyst-Quality

Work Location Logistics: Is it Hybrid, Onsite or Remote This is an onsite position requiring the team member to be onsite for all scheduled workdays. This is a hybrid position requiring the team member to be onsite for 3 days per week. This is a remote position allowing the team member to work from home.   Relocation: Is relocation assistance provided or not This position offers relocation assistance. No relocation assistance is provided for this opportunity.   Sponsorship: Is Sponsorship provided or not for this opportunity. This position offers relocation assistance. No relocation assistance is provided for this opportunity.   At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?     There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.     We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.   Job Summary

The Senior Analyst – Digital Quality Assurance acts as an independent quality reviewer and approver for Computer Software Validation (CSV) documentation. This role ensures that all GxP computer systems comply with West's procedures, global quality standards, and applicable regulatory requirements.

As a key member of the Digital Quality Assurance (DQA) team, the Senior Analyst partners closely with cross-functional stakeholders, including the Project Team, Digital & Technology (D&T) teams (especially the Validation and Infrastructure groups), and Site/Business representatives(as applicable).     Essential Duties and Responsibilities

Ensure adherence to West’s global CSV procedures and support the qualification and validation of new or upgraded GxP software applications and process improvements. Collaborate with project and technical teams to ensure regulatory and quality requirements are clearly defined, documented, and implemented for GxP applications. Review test protocols, test execution records, and deviations, ensuring complete and compliant evidence of validation testing. Review and approve change control documentation related to GxP computerized systems to ensure continued compliance and system integrity. Review and approve periodic reviews of GxP computer systems to verify compliance with current procedures, standards, and regulations. Deliver training and guidance to D&T teams, including validation engineers and system owners, on CSV processes, data integrity principles, and the application of quality system procedures. Support the Digital QA Lead during internal and external audits, inspections, and assessments related to QMS and CSV documentation. Participate in the preparation, review, and approval of Quality Assurance documentation related to digital systems, including quality plans, risk management records, and audit responses. Contribute to the creation, review, and periodic update of CSV procedures and work instructions, aligning them with current regulatory expectations and industry best practices. Participate in global quality initiatives and events, collaborating across teams to strengthen quality culture and promote continuous improvement within digital systems compliance.