Validation Specialist - Computer Systems Job Spokane area,Washington USA,Quality Assurance

Job Description

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

Perform periodic reviews and audit trail reviews of computerized systems.

Write and review documents to support the qualification of a computerized system, including:

Validation Plan
User Requirements Specification
Risk Assessment
Traceability Matrix
Qualification Protocol
Qualification Test Plan
Qualification Acceptance Report
Validation Plan Acceptance Report

Write and manage change control documents for computerized systems and assist with change controls for production computerized systems as necessary.

Write and review CSV SOPs.

Partner with other departments to ensure the site is compliant.

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 experience required.
GAMP 5 Certification strongly preferred.
Experience with Data Integrity, Computer Software Validation, GMP records storage and SAP preferred.

Location and Shift

Spokane, WA - On Site, Full-Time

Shift: Mon-Fri, 8am-5pm

Compensation & Benefits

Hiring Wage: $80,169.00 - $90,000.00, with opportunities for growth, promotion, and annual raises.

Benefits begin on day one:

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

Equal Employment Opportunity

Jubilant Hollister Stier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require assistance applying, contact J

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