Responsible for the computerized system validation and data integrity at the JHS-Spokane site. The job functions include periodic review and audit trail reviews. Drafting, reviewing, and executing equipment-specific test plans. Drafting and reviewing user requirement specifications, risk assessments, traceability matrix, and qualification protocols - including test plans and acceptance reports. Responsibilities - The responsibilities may include the following tasks, knowledge, skills and other characteristics. (This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.) 1. Perform Periodic Reviews and Audit Trail Reviews of computerized systems. 2. Write and review documents to support the qualification of a computerized system. 1. Validation Plan 2. User Requirements Specification 3. Risk Assessment 4. Traceability Matrix 5. Qualification Protocol 6. Qualification Test Plan 7. Qualification Acceptance Report 8. Validation Plan Acceptance Report 3. Write and manage change control documents for computerized systems and assist with change controls for production computerized systems as necessary. 4. Write and review CSV SOPs. 5. Partner with other departments to ensure the site is compliant. 6. Provide support for computerized systems during audits, deviations, and investigations. Qualifications: - Minimum 5 years related experience with BS degree or 10 years of experience without BS degree. - Experience with technical writing, building and manufacturing computer control processes/systems. - QA operation systems and validation is required. - GAMP 5 Certification strongly preferred. - Experience with Data Integrity, Computer Software Validation, GMP records storage and SAP preferred. Location: Spokane, WA - On Site, Full- -Time Shift: Mon-Fri. 8am-5pm Compensation & Benefits That Start on Day One - Because Your Well Being Matters Hiring Wage: $80,169.00 - $90,000.00, with opportunities for growth, promotion, and annual raises. At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success. Starting on your first day, you receive: - Medical, Dental & Vision coverage - Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA) - Life & AD&D Insurance - Short-Term & Long-Term Disability Insurance - Employee Assistance Program Unlock Your Potential If you're seeking a dynamic and rewarding career, we welcome your application today. Apply online: Careers - Jubilant HollisterStier